The Efficacy and Safety of Performing Percutaneous Transhepatic Cholangioscopy (PTCS) Under Local Anesthesia for Pregnant Patient Suffering Acute Cholecystitis: A Study Protocol of a Prospective, Single-center, Single-arm Pilot Study

The Efficacy and Safety of Performing Percutaneous Transhepatic Cholangioscopy (PTCS) Under Local Anesthesia for Pregnant Patient Suffering Acute Cholecystitis: A Study Protocol of a Prospective, Single-center, Single-arm Pilot Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol The Efficacy and Safety of Performing Percutaneous Transhepatic Cholangioscopy (PTCS) Under Local Anesthesia for Pregnant Patient Suffering Acute Cholecystitis: A Study Protocol of a Prospective, Single-center, Single-arm Pilot Study Andrew Liman, Rongxing Zhou This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5992794/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Acute cholecystitis (AC) during pregnancy presents a clinical dilemma, as standard treatments like laparoscopic cholecystectomy (LC) involve general anesthesia, which carries risks for both the mother and fetus. Percutaneous Transhepatic Cholangioscopy (PTCS) under local anesthesia has emerged as a promising alternative, offering a safer approach for pregnant patients with AC. This study evaluates the safety and efficacy of PTCS under local anesthesia in pregnant women with acute cholecystitis. Methods This prospective, single-center, open-label pilot study enrolled pregnant women aged 18–40 years, diagnosed with acute cholecystitis, who met the inclusion criteria. PTCS was performed under local anesthesia using 2% lidocaine and 15 mg dexamethasone for intercostal nerve blockade. The primary outcome was the resolution of acute cholecystitis, defined as successful gallstone removal and symptom relief. Secondary outcomes included maternal and fetal safety, recovery time, and the need for further interventions. Data were compared with historical control groups receiving conservative treatment or laparoscopic cholecystectomy. Discussion PTCS under local anesthesia demonstrated promising results in resolving acute cholecystitis, with minimal maternal and fetal complications. The procedure was well-tolerated, with reduced anesthesia-related risks and shorter recovery times compared to general anesthesia. Fetal safety was maintained, and no significant adverse outcomes were observed. This approach could offer an effective, minimally invasive alternative for managing acute cholecystitis in pregnant patients, reducing the need for more invasive surgical interventions. Larger, randomized studies are needed to confirm these findings and assess long-term outcomes. Trial registration PTCS Pregnant Patients Acute Cholecystitis Single-arm Pilot Study Study Protocol Background Patients with acute cholecystitis (AC) who receive early invasive treatment tend to experience better outcomes compared to those who undergo delayed intervention 1 . However, the management of pregnant women with acute calculus cholecystitis often presents a clinical dilemma. Conservative treatment with antibiotics alone has limited efficacy, and the standard treatment—laparoscopic cholecystectomy (LC) —requires general anesthesia, which carries potential risks for both the patient and the fetus 2 . All general anesthetic agents have been shown to cross the placenta 3 , raising concerns about their potential effects on fetal development. Notably, the U.S. Food and Drug Administration (FDA) issued a 2016 warning regarding the use of anesthetics during pregnancy, particularly in the third trimester, due to concerns about neurodevelopmental impacts on the fetus 4 . Traditional PTCS is typically performed under general anesthesia, but local anesthesia may provide a safer alternative for pregnant patients, reducing maternal and fetal risks. This approach minimizes the risks associated with general anesthesia, potentially improving both maternal and fetal outcomes. Furthermore, PTCS under local anesthesia may provide significant benefits throughout the entire care continuum, from the preoperative and intraoperative phases to postoperative recovery and discharge. In this study, we examine the efficacy and safety of performing PTCS under local anesthesia in pregnant patients. Specifically, we assess its impact on the quality of life throughout pregnancy and the outcomes of pregnancy itself. Materials and Methods Patient Selection This prospective, single-center, single-arm, open-label pilot study aimed to assess the safety and efficacy of Percutaneous Transhepatic Cholangioscopy (PTCS) under local anesthesia for pregnant patients with acute cholecystitis. Eligible participants were pregnant women aged 18 to 40 years, diagnosed with acute cholecystitis, and meeting the inclusion and exclusion criteria. Inclusion Criteria : 1) Female, aged 18 to 40 years; 2) Pregnant, in any trimester; 3) Diagnosed with acute cholecystitis Exclusion Criteria : 1) History or current presence of autoimmune disease; 2)History of anaphylaxis or severe allergic reactions; 3) Current use of anticoagulant therapy within 2 weeks of screening; 4) History of severe cardiopulmonary disease This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki, Chinese Good Clinical Practice guidelines, and local regulatory requirements. The study protocol and informed consent were approved by the Institutional Review Board (IRB) of our institution. All participants provided written informed consent prior to enrollment. Study Design This open-label pilot study aimed to evaluate the safety and efficacy of PTCS under local anesthesia in pregnant women with acute cholecystitis. The primary focus was on the resolution of acute cholecystitis, maternal and fetal outcomes, and the benefits of local anesthesia compared to general anesthesia. Study Setting The study was conducted at a single academic medical center with expertise in maternal-fetal medicine and advanced biliary procedures. Participants were recruited from the hospital's obstetrics and gastroenterology departments. Intervention PTCS was performed under local anesthesia using 2% lidocaine to block the intercostal nerves and the puncture site. The procedure involved ultrasound-guided puncture of the right hepatic parenchyma, followed by cholangioscopy for gallbladder visualization and treatment. Local anesthesia was carefully administered to minimize systemic absorption while ensuring adequate analgesia. All procedures were conducted by an experienced interventional radiologist and a maternal-fetal medicine specialist. Primary and Secondary Outcomes Primary Outcome Resolution of acute cholecystitis, defined as the successful removal of gallstones and relief of symptoms (pain, fever, elevated white blood cell count). Secondary Outcomes Maternal and fetal safety (including adverse pregnancy outcomes, fetal distress, preterm labor), recovery time (hospital stay, resumption of normal activities), and quality of life during pregnancy. Data Collection and Analysis Data on maternal and fetal outcomes were prospectively collected. Descriptive statistics were used to analyze baseline characteristics, procedural success rates, and outcome measures. Outcomes were compared with historical control data from patients receiving conservative treatment or laparoscopic cholecystectomy. Local Anesthesia Procedure Local anesthesia was administered at the 7th and 8th, as well as 8th and 9th, right paravertebral spaces. A combination of 15 mL of 33% ropivacaine and 15 mg dexamethasone was injected to achieve blockade of the intercostal nerves, providing region-specific numbness for the procedure. PTCS Procedure The procedure began with dilation of the existing Percutaneous Transhepatic Gallbladder Drainage (PTGD) fistula. A guidewire was advanced along the retained PTGD tube, and local anesthesia was administered at the puncture site using 2% lidocaine. The puncture channel was expanded to gain access to the gallbladder. Once access was achieved, a rigid cholangioscope was inserted to visualize the gallbladder, and fluid was flushed to dislodge smaller gallstones. Larger stones were fragmented using a ballistic lithoclast and retrieved with a lithotripter mesh basket. Intraoperative ultrasound was used to confirm the absence of residual gallstones. Efficacy Evaluation The efficacy of PTCS under local anesthesia was evaluated based on the following clinical endpoints: Resolution of Acute Cholecystitis: Success was defined by the removal of gallstones and relief of biliary obstruction, assessed through imaging and clinical symptoms (pain, fever, WBC count). Fetal and Maternal Outcomes: Fetal distress, preterm labor, miscarriage, and maternal complications (e.g., bleeding, infection) were recorded. Postoperative Recovery: Recovery time, length of hospital stay, and return to normal activities. Quality of Life: Assessed using patient-reported outcome measures (PROMs), including relief of symptoms and overall satisfaction with the procedure. Comparison with Traditional Treatments: Outcomes were compared with conservative antibiotic therapy and laparoscopic cholecystectomy, including maternal and fetal outcomes, as well as the need for further interventions. Safety Measures To ensure safety, the following precautions were taken: Patient Selection: Strict adherence to inclusion/exclusion criteria to ensure eligibility. Anesthesia Protocol: Local anesthesia was carefully administered using 2% lidocaine to minimize systemic absorption. Fetal Monitoring: Continuous monitoring of fetal well-being via ultrasound to assess fetal heart rate and amniotic fluid levels. Intraoperative Monitoring: Standard monitoring (blood pressure, heart rate, oxygen saturation) was used throughout the procedure. Infection Control: Strict aseptic techniques were followed, and prophylactic antibiotics were administered. Postoperative Care: Monitoring for complications such as bleeding or infection, with additional fetal monitoring as needed. Statistical Analyses Statistical analysis was performed using SPSS (version 25) or GraphPad Prism (version 9). Descriptive statistics summarized baseline characteristics. Fisher’s exact test was used for categorical variables (e.g., complications, fetal outcomes), while t-tests or Mann-Whitney U tests were used for continuous variables (e.g., recovery time, hospital stay). A p-value of < 0.05 was considered statistically significant. Discussion Infection is a significant contributor to pregnancy loss, with studies indicating that it may account for up to 15% of early miscarriages and up to 66% of late miscarriages 5 – 7 . Guidelines recommend early LC for pregnant women with AC 8 – 11 , acknowledging that while surgery during pregnancy is often necessary, it carries inherent risks to both the mother and fetus. Non-urgent surgeries should be postponed until after delivery to minimize potential harm 11 . In a study comparing operative versus non-operative management of AC during pregnancy, pregnancy loss occurred in 11.3% (134 out of 1182) of patients who underwent open cholecystectomy (OC) or LC, compared to 10.5% (235 out of 2244) in those receiving conservative antibiotic treatment 12 . This difference—approximately 0.8%—highlights the relatively small but significant additional risk associated with surgical interventions during pregnancy. The prenatal period is characterized by heightened sensitivity to neurotoxic drugs, and there is growing concern regarding the impact of general anesthesia on fetal neurodevelopment 13 . Preclinical studies have linked specific periods of fetal brain development to peak vulnerability from anesthetic exposure 14 , 15 . Maternal exposure to general anesthesia has been linked to negative neurodevelopmental outcomes in children, including behavioral issues 16 . For instance, the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) study found that children exposed to anesthesia during pregnancy had significantly worse Child Behavior Checklist (CBCL) total and internalizing scores than their unexposed siblings 17 . Similarly, the Mayo Anesthesia Safety in Children (MASK) study reported worse CBCL scores in children who had undergone multiple anesthetic exposures 18 . These findings underscore the potential risks of general anesthesia for both the pregnant woman and the fetus, particularly with regard to long-term neurodevelopmental outcomes. Given these concerns, PTCS performed under local anesthesia presents a promising alternative. Unlike conservative antibiotic therapy, which only addresses the symptoms of acute cholecystitis, PTCS resolves the underlying cause by directly removing gallstones. Additionally, compared to percutaneous transhepatic gallbladder drainage (PTGD), PTCS offers the advantage of real-time visualization of the gallbladder 19 , making it safer and reducing radiation exposure when compared to ERCP 20 . PTCS provides more thorough control of cholecystitis, and the drainage tube, typically placed during the procedure, can often be removed within two weeks. This approach significantly reduces the risk of needing further intervention during pregnancy, with laparoscopic cholecystectomy remaining an option postpartum. The use of local anesthesia in PTCS offers several advantages over general anesthesia in pregnant women. Local anesthesia avoids the systemic effects of general anesthetics, which can negatively impact both maternal and fetal health. Additionally, local anesthesia is associated with reduced cardiovascular and pulmonary stress, minimized need for intraoperative monitoring and medication, and a shorter recovery period. It is also associated with fewer complications compared to surgeries requiring general anesthesia. Psychologically, the lower risk associated with local anesthesia allows patients to remain awake and engaged during the procedure, which can help alleviate fear and anxiety. Ultrasound-guided PTCS performed under local anesthesia has emerged as a safe and effective option for pregnant patients with acute cholecystitis who are at increased risk from general anesthesia 21 – 24 . The potential benefits of this approach include: 1) reduced anesthesia-related risks; 2) decreased impact on cardiovascular and pulmonary function; 3) less need for extensive intraoperative monitoring and medications; 4) a shorter recovery period; 5) fewer postoperative complications; and 6) reduced psychological stress, as patients can remain alert and informed throughout the procedure. In examining miscarriage rates, studies have shown variability depending on geographic, demographic, and socioeconomic factors. Large cohort studies from Europe and North America, which collectively involved 4.64 million pregnancies, reported an overall miscarriage rate of 15.3% (95% CI 12.5–18.7%) 25 – 32 . A Chinese study involving 299,582 women found a lower miscarriage rate of 9.06%, with 13.88% reporting at least one pregnancy loss, including both miscarriages and stillbirths 33 . These differences are likely influenced by various factors such as race, lifestyle, geography, environment, socioeconomic status, body mass index (BMI), chronic health conditions, and family history, all of which may contribute to the varying miscarriage rates. This study has several limitations, including its relatively small sample size and the absence of randomization in patient group selection. Additionally, the short follow-up period restricts the ability to assess the long-term safety and efficacy of PTCS for both the pregnant patient and the fetus. Future randomized controlled trials with larger sample sizes and extended follow-up periods are necessary to further evaluate the long-term outcomes, including the safety and durability of PTCS under local anesthesia. Declarations Conflict of interest disclosures: The authors declare that they have no conflict of interest. Contributors: Andrew Liman wrote the article, developed the study concept and protocol. Rongxing Zhou supervises the clinical trial and has access to the final trial dataset. All authors contributed to the article and approved the submitted version. Funding statement: This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. References Jared RG, Anthony C. Acute Cholecystitis: A Review. JAMA. 2022;327(10):965-975. doi: 10.1001/jama.2022.2350. Michele P, Niccolò A, Kurinchi G, et al. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020;15:61. doi: 10.1186/s13017-020-00336-x. Flood P, Rollins MD. Anesthesia for Obstetrics. In: Miller RD, ed. Miller’s anesthesia. Eighth edition. ed. Philadelphia, PA: Elsevier/Saunders; 2015:2328–59. FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women [12–14-2016]. Sindhu KS, Yujie Ma, Mary DS, et al. Placental inflammation and viral infection are implicated in second trimester pregnancy loss. Am J Obstet Gynecol. 2006;195(3):797-802. doi: 10.1016/j.ajog.2006.05.049. David B, Lesley R, Gilbert G. Emerging role of Chlamydia and Chlamydia-like organisms in adverse pregnancy outcomes. Curr Opin Infect Dis. 2008;21(1):70-6. doi: 10.1097/QCO.0b013e3282f3e6a5. Athena P K, Jennifer S R, Denise J J. Pregnancy and infection. N Engl J Med. 2014;370(23):2211-8. doi: 10.1056/NEJMra1213566. Sunjay SK, Amelia TC, Claire W, et al. SAGES guidelines for the use of laparoscopy during pregnancy. Surg Endosc. 2024;38(6):2947-2963. doi: 10.1007/s00464-024-10810-1. Tran TT, Ahn J, Reau NS (2016) ACG clinical guideline: liver disease and pregnancy. Am J Gastroenterol 111(2):176–194. ACOG committee opinion No. 775: nonobstetric surgery during pregnancy. Obstet Gynecol 133:e285–e286. 10.1097/AOG.0000000000003174. Ball E, Waters N, Cooper N, et al. Evidence-Based Guideline on Laparoscopy in Pregnancy: Commissioned by the British Society for Gynaecological Endoscopy (BSGE) Endorsed by the Royal College of Obstetricians & Gynaecologists (RCOG). Facts Views Vis Obgyn 2019; 11:5. Mariam NH, David JD, Michael GN, et al. Operative vs Nonoperative Management of Acute Cholecystitis During the Different Trimesters of Pregnancy. JAMA Surg. 2023;159(1):28–34. doi: 10.1001/jamasurg.2023.5803. Heyer DB, Meredith RM. Environmental toxicology: Sensitive periods of development and neurodevelopmental disorders. Neurotoxicology 2017;58:23–41. Vutskits L, Xie Z. Lasting impact of general anaesthesia on the brain: mechanisms and relevance. Nat Rev Neurosci 2016;17:705–17. Semple BD, Blomgren K, Gimlin K, et al. Brain development in rodents and humans: Identifying benchmarks of maturation and vulnerability to injury across species. Prog Neurobiol 2013;106–107:1–16. Caleb I, Ruth L, David D, et al. Prenatal Exposure to General Anesthesia and Childhood Behavioral Deficit. Anesth Analg. 2021 Sep 1;133(3):595–605. doi: 10.1213/ANE.0000000000005389. Sun LS, Li G, Miller TL, et al. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA 2016;315:2312–20. Warner DO, Zaccariello MJ, Katusic SK, et al. Neuropsychological and Behavioral Outcomes after Exposure of Young Children to Procedures Requiring General Anesthesia: The Mayo Anesthesia Safety in Kids (MASK) Study. Anesthesiology 2018;129:89–105. Hua Z, ZeMing C, RunZhui L, et al. Percutaneous Transhepatic Choledochoscopic Lithotomy (PTCSL) is Effective for the Treatment of Intrahepatic and Extrahepatic Choledocholithiasis. Surg Laparosc Endosc Percutan Tech. 2020;31(3):326-330. doi: 10.1097/SLE.0000000000000874. Deheragoda M. Normal Liver Anatomy and Introduction to Liver Histology. Textbook of Pediatric Gastroenterology, Hepatology and Nutrition: A Comprehensive Guide to Practice 2022: 739-742. Susana V, Daniel JC, Maxime C. Cognitive Decline Associated With Anesthesia and Surgery in Older Patients. JAMA. 2021; 326(24):2531-2531. 10.1001/jama.2021.20285. doi: 10.1001/jama.2021.4773. L Evered, K Atkins, B Silbert, et al. Acute peri-operative neurocognitive disorders: a narrative review. Anaesthesia 2022;77 Suppl 1:34-42. doi: 10.1111/anae.15613. Mary EM, Sulpicio GS. Does general anesthesia affect neurodevelopment in infants and children? BMJ 2019;367:l6459. doi: 10.1136/bmj.l6459. Laszlo V, Zhongcong X. Lasting impact of general anaesthesia on the brain: mechanisms and relevance. Nat Rev Neurosci 2016;17(11):705-717. doi: 10.1038/nrn.2016.128. Himmelberger DU, Brown BW Jr, Cohen EN. Cigarette smoking during pregnancy and the occurrence of spontaneous abortion and congenital abnormality. Am J Epidemiol 1978; 108: 470–79. Armstrong BG, McDonald AD, Sloan M. Cigarette, alcohol, and coffee consumption and spontaneous abortion. Am J Public Health 1992; 82: 85–87. Nybo Andersen AM, Wohlfahrt J, Christens P, Olsen J, Melbye M. Maternal age and fetal loss: population based register linkage study. BMJ 2000; 320: 1708–12. Adolfsson A, Larsson PG. Cumulative incidence of previous spontaneous abortion in Sweden in 1983–2003: a register study. Acta Obstet Gynecol Scand 2006; 85: 741–47. Linnakaari R, Helle N, Mentula M, et al. Trends in the incidence, rate and treatment of miscarriage-nationwide register-study in Finland, 1998–2016. Hum Reprod 2019; 34: 2120–28. Magnus MC, Wilcox AJ, Morken NH, Weinberg CR, Håberg SE. Role of maternal age and pregnancy history in risk of miscarriage: prospective register based study. BMJ 2019; 364: l869. Rossen LM, Ahrens KA, Branum AM. Trends in risk of pregnancy loss among US women, 1990–2011. Paediatr Perinat Epidemiol 2018; 32: 19–29. Nguyen BT, Chang EJ, Bendikson KA. Advanced paternal age and the risk of spontaneous abortion: an analysis of the combined 2011–2013 and 2013–2015 National Survey of Family Growth. Am J Obstet Gynecol 2019; 221: 476.e1–7. Li J, Sha H, Jia YH, et al. Pregnancy Loss and Risk of All-Cause Mortality in Chinese Women: Findings From the China Kadoorie Biobank. Int J Public Health. 2023;68:1605429. doi: 10.3389/ijph.2023.1605429. Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5992794","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":413522568,"identity":"9c1362e8-a58b-4cba-bae5-bb110e43b7be","order_by":0,"name":"Andrew Liman","email":"","orcid":"","institution":"Biliary Surgical Department of West China Hospital","correspondingAuthor":false,"prefix":"","firstName":"Andrew","middleName":"","lastName":"Liman","suffix":""},{"id":413522569,"identity":"ba7bbc14-0740-4e85-87ac-ef629785b221","order_by":1,"name":"Rongxing Zhou","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6UlEQVRIie3RMQrCMBSA4UihLgHXQKFe4UmgKJT2Ki2FTEUKXqDiWveAglfwCEqwXcTZwcHJxaXg4lDQBEGcGkfB/JCQQD5CCEIm0w8W5moGOYgcNfiulsDmg3R4xuiXBL2IhWsR60k1F1ecnYLVYlY6PlgR6orduo2ExYGNOFyS6bJkTgr2GGHGjm0kIKkHNYjEkgtJ8AQR7LUSqkgkia3IEEic68iAp/QsbwmwIghAT2C/9zocREQIS0YFRNTWvQWqgt5wI8I+T7bHe/Nwe11RthKZrf49zt9bzXGVVcsp/OKgyWQy/WtP8lNIPxkf4DEAAAAASUVORK5CYII=","orcid":"","institution":"Biliary Surgical Department of West China Hospital","correspondingAuthor":true,"prefix":"","firstName":"Rongxing","middleName":"","lastName":"Zhou","suffix":""}],"badges":[],"createdAt":"2025-02-09 13:53:12","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5992794/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5992794/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":104015772,"identity":"432b6b59-3a7d-4e1c-bed1-80010ed63e6a","added_by":"auto","created_at":"2026-03-05 16:55:37","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":499071,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5992794/v1/88a3e605-b403-4f23-8d7a-017d7faf6781.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"The Efficacy and Safety of Performing Percutaneous Transhepatic Cholangioscopy (PTCS) Under Local Anesthesia for Pregnant Patient Suffering Acute Cholecystitis: A Study Protocol of a Prospective, Single-center, Single-arm Pilot Study","fulltext":[{"header":"Background","content":"\u003cp\u003ePatients with acute cholecystitis (AC) who receive early invasive treatment tend to experience better outcomes compared to those who undergo delayed intervention \u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e. However, the management of pregnant women with acute calculus cholecystitis often presents a clinical dilemma. Conservative treatment with antibiotics alone has limited efficacy, and the standard treatment\u0026mdash;laparoscopic cholecystectomy (LC) \u0026mdash;requires general anesthesia, which carries potential risks for both the patient and the fetus \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. All general anesthetic agents have been shown to cross the placenta \u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e, raising concerns about their potential effects on fetal development. Notably, the U.S. Food and Drug Administration (FDA) issued a 2016 warning regarding the use of anesthetics during pregnancy, particularly in the third trimester, due to concerns about neurodevelopmental impacts on the fetus \u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e .\u003c/p\u003e \u003cp\u003eTraditional PTCS is typically performed under general anesthesia, but local anesthesia may provide a safer alternative for pregnant patients, reducing maternal and fetal risks. This approach minimizes the risks associated with general anesthesia, potentially improving both maternal and fetal outcomes. Furthermore, PTCS under local anesthesia may provide significant benefits throughout the entire care continuum, from the preoperative and intraoperative phases to postoperative recovery and discharge.\u003c/p\u003e \u003cp\u003eIn this study, we examine the efficacy and safety of performing PTCS under local anesthesia in pregnant patients. Specifically, we assess its impact on the quality of life throughout pregnancy and the outcomes of pregnancy itself.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePatient Selection\u003c/h2\u003e \u003cp\u003e This prospective, single-center, single-arm, open-label pilot study aimed to assess the safety and efficacy of Percutaneous Transhepatic Cholangioscopy (PTCS) under local anesthesia for pregnant patients with acute cholecystitis. Eligible participants were pregnant women aged 18 to 40 years, diagnosed with acute cholecystitis, and meeting the inclusion and exclusion criteria.\u003c/p\u003e \u003cp\u003e \u003cb\u003eInclusion Criteria\u003c/b\u003e: 1) Female, aged 18 to 40 years; 2) Pregnant, in any trimester; 3) Diagnosed with acute cholecystitis\u003c/p\u003e \u003cp\u003e \u003cb\u003eExclusion Criteria\u003c/b\u003e: 1) History or current presence of autoimmune disease; 2)History of anaphylaxis or severe allergic reactions; 3) Current use of anticoagulant therapy within 2 weeks of screening; 4) History of severe cardiopulmonary disease\u003c/p\u003e \u003cp\u003e This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki, Chinese Good Clinical Practice guidelines, and local regulatory requirements. The study protocol and informed consent were approved by the Institutional Review Board (IRB) of our institution. All participants provided written informed consent prior to enrollment.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStudy Design\u003c/h3\u003e\n\u003cp\u003eThis open-label pilot study aimed to evaluate the safety and efficacy of PTCS under local anesthesia in pregnant women with acute cholecystitis. The primary focus was on the resolution of acute cholecystitis, maternal and fetal outcomes, and the benefits of local anesthesia compared to general anesthesia.\u003c/p\u003e\n\u003ch3\u003eStudy Setting\u003c/h3\u003e\n\u003cp\u003eThe study was conducted at a single academic medical center with expertise in maternal-fetal medicine and advanced biliary procedures. Participants were recruited from the hospital's obstetrics and gastroenterology departments.\u003c/p\u003e\n\u003ch3\u003eIntervention\u003c/h3\u003e\n\u003cp\u003ePTCS was performed under local anesthesia using 2% lidocaine to block the intercostal nerves and the puncture site. The procedure involved ultrasound-guided puncture of the right hepatic parenchyma, followed by cholangioscopy for gallbladder visualization and treatment. Local anesthesia was carefully administered to minimize systemic absorption while ensuring adequate analgesia. All procedures were conducted by an experienced interventional radiologist and a maternal-fetal medicine specialist.\u003c/p\u003e\n\u003ch3\u003ePrimary and Secondary Outcomes\u003c/h3\u003e\n\u003cp\u003e \u003cstrong\u003ePrimary Outcome\u003c/strong\u003e \u003cp\u003eResolution of acute cholecystitis, defined as the successful removal of gallstones and relief of symptoms (pain, fever, elevated white blood cell count).\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eSecondary Outcomes\u003c/strong\u003e \u003cp\u003eMaternal and fetal safety (including adverse pregnancy outcomes, fetal distress, preterm labor), recovery time (hospital stay, resumption of normal activities), and quality of life during pregnancy.\u003c/p\u003e \u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData Collection and Analysis\u003c/h2\u003e \u003cp\u003eData on maternal and fetal outcomes were prospectively collected. Descriptive statistics were used to analyze baseline characteristics, procedural success rates, and outcome measures. Outcomes were compared with historical control data from patients receiving conservative treatment or laparoscopic cholecystectomy.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eLocal Anesthesia Procedure\u003c/h3\u003e\n\u003cp\u003eLocal anesthesia was administered at the 7th and 8th, as well as 8th and 9th, right paravertebral spaces. A combination of 15 mL of 33% ropivacaine and 15 mg dexamethasone was injected to achieve blockade of the intercostal nerves, providing region-specific numbness for the procedure.\u003c/p\u003e\n\u003ch3\u003ePTCS Procedure\u003c/h3\u003e\n\u003cp\u003eThe procedure began with dilation of the existing Percutaneous Transhepatic Gallbladder Drainage (PTGD) fistula. A guidewire was advanced along the retained PTGD tube, and local anesthesia was administered at the puncture site using 2% lidocaine. The puncture channel was expanded to gain access to the gallbladder. Once access was achieved, a rigid cholangioscope was inserted to visualize the gallbladder, and fluid was flushed to dislodge smaller gallstones. Larger stones were fragmented using a ballistic lithoclast and retrieved with a lithotripter mesh basket. Intraoperative ultrasound was used to confirm the absence of residual gallstones.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eEfficacy Evaluation\u003c/h2\u003e \u003cp\u003eThe efficacy of PTCS under local anesthesia was evaluated based on the following clinical endpoints:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eResolution of Acute Cholecystitis: Success was defined by the removal of gallstones and relief of biliary obstruction, assessed through imaging and clinical symptoms (pain, fever, WBC count).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eFetal and Maternal Outcomes: Fetal distress, preterm labor, miscarriage, and maternal complications (e.g., bleeding, infection) were recorded.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePostoperative Recovery: Recovery time, length of hospital stay, and return to normal activities.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eQuality of Life: Assessed using patient-reported outcome measures (PROMs), including relief of symptoms and overall satisfaction with the procedure.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eComparison with Traditional Treatments: Outcomes were compared with conservative antibiotic therapy and laparoscopic cholecystectomy, including maternal and fetal outcomes, as well as the need for further interventions.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eSafety Measures\u003c/h2\u003e \u003cp\u003eTo ensure safety, the following precautions were taken:\u003c/p\u003e \u003cp\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003ePatient Selection: Strict adherence to inclusion/exclusion criteria to ensure eligibility.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eAnesthesia Protocol: Local anesthesia was carefully administered using 2% lidocaine to minimize systemic absorption.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eFetal Monitoring: Continuous monitoring of fetal well-being via ultrasound to assess fetal heart rate and amniotic fluid levels.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eIntraoperative Monitoring: Standard monitoring (blood pressure, heart rate, oxygen saturation) was used throughout the procedure.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eInfection Control: Strict aseptic techniques were followed, and prophylactic antibiotics were administered.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003ePostoperative Care: Monitoring for complications such as bleeding or infection, with additional fetal monitoring as needed.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analyses\u003c/h2\u003e \u003cp\u003eStatistical analysis was performed using SPSS (version 25) or GraphPad Prism (version 9). Descriptive statistics summarized baseline characteristics. Fisher\u0026rsquo;s exact test was used for categorical variables (e.g., complications, fetal outcomes), while t-tests or Mann-Whitney U tests were used for continuous variables (e.g., recovery time, hospital stay). A p-value of \u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eInfection is a significant contributor to pregnancy loss, with studies indicating that it may account for up to 15% of early miscarriages and up to 66% of late miscarriages \u003csup\u003e\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. Guidelines recommend early LC for pregnant women with AC \u003csup\u003e\u003cspan additionalcitationids=\"CR9 CR10\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e, acknowledging that while surgery during pregnancy is often necessary, it carries inherent risks to both the mother and fetus. Non-urgent surgeries should be postponed until after delivery to minimize potential harm \u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. In a study comparing operative versus non-operative management of AC during pregnancy, pregnancy loss occurred in 11.3% (134 out of 1182) of patients who underwent open cholecystectomy (OC) or LC, compared to 10.5% (235 out of 2244) in those receiving conservative antibiotic treatment \u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. This difference\u0026mdash;approximately 0.8%\u0026mdash;highlights the relatively small but significant additional risk associated with surgical interventions during pregnancy.\u003c/p\u003e \u003cp\u003eThe prenatal period is characterized by heightened sensitivity to neurotoxic drugs, and there is growing concern regarding the impact of general anesthesia on fetal neurodevelopment \u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. Preclinical studies have linked specific periods of fetal brain development to peak vulnerability from anesthetic exposure \u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e,\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. Maternal exposure to general anesthesia has been linked to negative neurodevelopmental outcomes in children, including behavioral issues \u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e. For instance, the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) study found that children exposed to anesthesia during pregnancy had significantly worse Child Behavior Checklist (CBCL) total and internalizing scores than their unexposed siblings \u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. Similarly, the Mayo Anesthesia Safety in Children (MASK) study reported worse CBCL scores in children who had undergone multiple anesthetic exposures \u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. These findings underscore the potential risks of general anesthesia for both the pregnant woman and the fetus, particularly with regard to long-term neurodevelopmental outcomes.\u003c/p\u003e \u003cp\u003eGiven these concerns, PTCS performed under local anesthesia presents a promising alternative. Unlike conservative antibiotic therapy, which only addresses the symptoms of acute cholecystitis, PTCS resolves the underlying cause by directly removing gallstones. Additionally, compared to percutaneous transhepatic gallbladder drainage (PTGD), PTCS offers the advantage of real-time visualization of the gallbladder \u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e, making it safer and reducing radiation exposure when compared to ERCP \u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e. PTCS provides more thorough control of cholecystitis, and the drainage tube, typically placed during the procedure, can often be removed within two weeks. This approach significantly reduces the risk of needing further intervention during pregnancy, with laparoscopic cholecystectomy remaining an option postpartum.\u003c/p\u003e \u003cp\u003eThe use of local anesthesia in PTCS offers several advantages over general anesthesia in pregnant women. Local anesthesia avoids the systemic effects of general anesthetics, which can negatively impact both maternal and fetal health. Additionally, local anesthesia is associated with reduced cardiovascular and pulmonary stress, minimized need for intraoperative monitoring and medication, and a shorter recovery period. It is also associated with fewer complications compared to surgeries requiring general anesthesia. Psychologically, the lower risk associated with local anesthesia allows patients to remain awake and engaged during the procedure, which can help alleviate fear and anxiety.\u003c/p\u003e \u003cp\u003eUltrasound-guided PTCS performed under local anesthesia has emerged as a safe and effective option for pregnant patients with acute cholecystitis who are at increased risk from general anesthesia \u003csup\u003e\u003cspan additionalcitationids=\"CR22 CR23\" citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e. The potential benefits of this approach include: 1) reduced anesthesia-related risks; 2) decreased impact on cardiovascular and pulmonary function; 3) less need for extensive intraoperative monitoring and medications; 4) a shorter recovery period; 5) fewer postoperative complications; and 6) reduced psychological stress, as patients can remain alert and informed throughout the procedure.\u003c/p\u003e \u003cp\u003eIn examining miscarriage rates, studies have shown variability depending on geographic, demographic, and socioeconomic factors. Large cohort studies from Europe and North America, which collectively involved 4.64\u0026nbsp;million pregnancies, reported an overall miscarriage rate of 15.3% (95% CI 12.5\u0026ndash;18.7%) \u003csup\u003e\u003cspan additionalcitationids=\"CR26 CR27 CR28 CR29 CR30 CR31\" citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. A Chinese study involving 299,582 women found a lower miscarriage rate of 9.06%, with 13.88% reporting at least one pregnancy loss, including both miscarriages and stillbirths \u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e. These differences are likely influenced by various factors such as race, lifestyle, geography, environment, socioeconomic status, body mass index (BMI), chronic health conditions, and family history, all of which may contribute to the varying miscarriage rates.\u003c/p\u003e \u003cp\u003eThis study has several limitations, including its relatively small sample size and the absence of randomization in patient group selection. Additionally, the short follow-up period restricts the ability to assess the long-term safety and efficacy of PTCS for both the pregnant patient and the fetus. Future randomized controlled trials with larger sample sizes and extended follow-up periods are necessary to further evaluate the long-term outcomes, including the safety and durability of PTCS under local anesthesia.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eConflict of interest disclosures:\u003c/strong\u003e The authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eContributors:\u003c/strong\u003e Andrew Liman wrote the article, developed the study concept and protocol. Rongxing Zhou supervises the clinical trial and has access to the final trial dataset. All authors contributed to the article and approved the submitted version.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding statement:\u003c/strong\u003e This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eJared RG, Anthony C. Acute Cholecystitis: A Review. JAMA. 2022;327(10):965-975. doi: 10.1001/jama.2022.2350.\u003c/li\u003e\n\u003cli\u003eMichele P, Niccol\u0026ograve; A, Kurinchi G, et al. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020;15:61. doi: 10.1186/s13017-020-00336-x.\u003c/li\u003e\n\u003cli\u003eFlood P, Rollins MD. Anesthesia for Obstetrics. In: Miller RD, ed. Miller\u0026rsquo;s anesthesia. Eighth edition. ed. Philadelphia, PA: Elsevier/Saunders; 2015:2328\u0026ndash;59.\u003c/li\u003e\n\u003cli\u003eFDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women [12\u0026ndash;14-2016].\u003c/li\u003e\n\u003cli\u003eSindhu KS, Yujie Ma, Mary DS, et al. Placental inflammation and viral infection are implicated in second trimester pregnancy loss. Am J Obstet Gynecol. 2006;195(3):797-802. doi: 10.1016/j.ajog.2006.05.049.\u003c/li\u003e\n\u003cli\u003eDavid B, Lesley R, Gilbert G. Emerging role of Chlamydia and Chlamydia-like organisms in adverse pregnancy outcomes. Curr Opin Infect Dis. 2008;21(1):70-6. doi: 10.1097/QCO.0b013e3282f3e6a5.\u003c/li\u003e\n\u003cli\u003eAthena P K, Jennifer S R, Denise J J. Pregnancy and infection. N Engl J Med. 2014;370(23):2211-8. doi: 10.1056/NEJMra1213566.\u003c/li\u003e\n\u003cli\u003eSunjay SK, Amelia TC, Claire W, et al. SAGES guidelines for the use of laparoscopy during pregnancy. Surg Endosc. 2024;38(6):2947-2963. doi: 10.1007/s00464-024-10810-1.\u003c/li\u003e\n\u003cli\u003eTran TT, Ahn J, Reau NS (2016) ACG clinical guideline: liver disease and pregnancy. Am J Gastroenterol 111(2):176\u0026ndash;194.\u003c/li\u003e\n\u003cli\u003eACOG committee opinion No. 775: nonobstetric surgery during pregnancy. Obstet Gynecol 133:e285\u0026ndash;e286. 10.1097/AOG.0000000000003174.\u003c/li\u003e\n\u003cli\u003eBall E, Waters N, Cooper N, et al. Evidence-Based Guideline on Laparoscopy in Pregnancy: Commissioned by the British Society for Gynaecological Endoscopy (BSGE) Endorsed by the Royal College of Obstetricians \u0026amp; Gynaecologists (RCOG). Facts Views Vis Obgyn 2019; 11:5.\u003c/li\u003e\n\u003cli\u003eMariam NH, David JD, Michael GN, et al. Operative vs Nonoperative Management of Acute Cholecystitis During the Different Trimesters of Pregnancy. JAMA Surg. 2023;159(1):28\u0026ndash;34. doi: 10.1001/jamasurg.2023.5803.\u003c/li\u003e\n\u003cli\u003eHeyer DB, Meredith RM. Environmental toxicology: Sensitive periods of development and neurodevelopmental disorders. Neurotoxicology 2017;58:23\u0026ndash;41.\u003c/li\u003e\n\u003cli\u003eVutskits L, Xie Z. Lasting impact of general anaesthesia on the brain: mechanisms and relevance. Nat Rev Neurosci 2016;17:705\u0026ndash;17.\u003c/li\u003e\n\u003cli\u003eSemple BD, Blomgren K, Gimlin K, et al. Brain development in rodents and humans: Identifying benchmarks of maturation and vulnerability to injury across species. Prog Neurobiol 2013;106\u0026ndash;107:1\u0026ndash;16.\u003c/li\u003e\n\u003cli\u003eCaleb I, Ruth L, David D, et al. Prenatal Exposure to General Anesthesia and Childhood Behavioral Deficit. Anesth Analg. 2021 Sep 1;133(3):595\u0026ndash;605. doi: 10.1213/ANE.0000000000005389.\u003c/li\u003e\n\u003cli\u003eSun LS, Li G, Miller TL, et al. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA 2016;315:2312\u0026ndash;20.\u003c/li\u003e\n\u003cli\u003eWarner DO, Zaccariello MJ, Katusic SK, et al. Neuropsychological and Behavioral Outcomes after Exposure of Young Children to Procedures Requiring General Anesthesia: The Mayo Anesthesia Safety in Kids (MASK) Study. Anesthesiology 2018;129:89\u0026ndash;105.\u003c/li\u003e\n\u003cli\u003eHua Z, ZeMing C, RunZhui L, et al. Percutaneous Transhepatic Choledochoscopic Lithotomy (PTCSL) is Effective for the Treatment of Intrahepatic and Extrahepatic Choledocholithiasis. Surg Laparosc Endosc Percutan Tech. 2020;31(3):326-330. doi: 10.1097/SLE.0000000000000874.\u003c/li\u003e\n\u003cli\u003eDeheragoda M. Normal Liver Anatomy and Introduction to Liver Histology. Textbook of Pediatric Gastroenterology, Hepatology and Nutrition: A Comprehensive Guide to Practice 2022: 739-742.\u003c/li\u003e\n\u003cli\u003eSusana V, Daniel JC, Maxime C. Cognitive Decline Associated With Anesthesia and Surgery in Older Patients. JAMA. 2021; 326(24):2531-2531. 10.1001/jama.2021.20285. doi: 10.1001/jama.2021.4773.\u003c/li\u003e\n\u003cli\u003eL Evered, K Atkins, B Silbert, et al. Acute peri-operative neurocognitive disorders: a narrative review. Anaesthesia 2022;77 Suppl 1:34-42. doi: 10.1111/anae.15613.\u003c/li\u003e\n\u003cli\u003eMary EM, Sulpicio GS. Does general anesthesia affect neurodevelopment in infants and children? BMJ 2019;367:l6459. doi: 10.1136/bmj.l6459.\u003c/li\u003e\n\u003cli\u003eLaszlo V, Zhongcong X. Lasting impact of general anaesthesia on the brain: mechanisms and relevance. Nat Rev Neurosci 2016;17(11):705-717. doi: 10.1038/nrn.2016.128.\u003c/li\u003e\n\u003cli\u003eHimmelberger DU, Brown BW Jr, Cohen EN. Cigarette smoking during pregnancy and the occurrence of spontaneous abortion and congenital abnormality. Am J Epidemiol 1978; 108: 470\u0026ndash;79.\u003c/li\u003e\n\u003cli\u003eArmstrong BG, McDonald AD, Sloan M. Cigarette, alcohol, and coffee consumption and spontaneous abortion. Am J Public Health 1992; 82: 85\u0026ndash;87.\u003c/li\u003e\n\u003cli\u003eNybo Andersen AM, Wohlfahrt J, Christens P, Olsen J, Melbye M. Maternal age and fetal loss: population based register linkage study. BMJ 2000; 320: 1708\u0026ndash;12.\u003c/li\u003e\n\u003cli\u003eAdolfsson A, Larsson PG. Cumulative incidence of previous spontaneous abortion in Sweden in 1983\u0026ndash;2003: a register study. Acta Obstet Gynecol Scand 2006; 85: 741\u0026ndash;47.\u003c/li\u003e\n\u003cli\u003eLinnakaari R, Helle N, Mentula M, et al. Trends in the incidence, rate and treatment of miscarriage-nationwide register-study in Finland, 1998\u0026ndash;2016. Hum Reprod 2019; 34: 2120\u0026ndash;28.\u003c/li\u003e\n\u003cli\u003eMagnus MC, Wilcox AJ, Morken NH, Weinberg CR, H\u0026aring;berg SE. Role of maternal age and pregnancy history in risk of miscarriage: prospective register based study. BMJ 2019; 364: l869.\u003c/li\u003e\n\u003cli\u003eRossen LM, Ahrens KA, Branum AM. Trends in risk of pregnancy loss among US women, 1990\u0026ndash;2011. Paediatr Perinat Epidemiol 2018; 32: 19\u0026ndash;29.\u003c/li\u003e\n\u003cli\u003eNguyen BT, Chang EJ, Bendikson KA. Advanced paternal age and the risk of spontaneous abortion: an analysis of the combined 2011\u0026ndash;2013 and 2013\u0026ndash;2015 National Survey of Family Growth. Am J Obstet Gynecol 2019; 221: 476.e1\u0026ndash;7.\u003c/li\u003e\n\u003cli\u003eLi J, Sha H, Jia YH, et al. Pregnancy Loss and Risk of All-Cause Mortality in Chinese Women: Findings From the China Kadoorie Biobank. Int J Public Health. 2023;68:1605429. doi: 10.3389/ijph.2023.1605429.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"PTCS, Pregnant Patients, Acute Cholecystitis, Single-arm Pilot Study, Study Protocol","lastPublishedDoi":"10.21203/rs.3.rs-5992794/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5992794/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAcute cholecystitis (AC) during pregnancy presents a clinical dilemma, as standard treatments like laparoscopic cholecystectomy (LC) involve general anesthesia, which carries risks for both the mother and fetus. Percutaneous Transhepatic Cholangioscopy (PTCS) under local anesthesia has emerged as a promising alternative, offering a safer approach for pregnant patients with AC. This study evaluates the safety and efficacy of PTCS under local anesthesia in pregnant women with acute cholecystitis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis prospective, single-center, open-label pilot study enrolled pregnant women aged 18–40 years, diagnosed with acute cholecystitis, who met the inclusion criteria. PTCS was performed under local anesthesia using 2% lidocaine and 15 mg dexamethasone for intercostal nerve blockade. The primary outcome was the resolution of acute cholecystitis, defined as successful gallstone removal and symptom relief. Secondary outcomes included maternal and fetal safety, recovery time, and the need for further interventions. Data were compared with historical control groups receiving conservative treatment or laparoscopic cholecystectomy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePTCS under local anesthesia demonstrated promising results in resolving acute cholecystitis, with minimal maternal and fetal complications. The procedure was well-tolerated, with reduced anesthesia-related risks and shorter recovery times compared to general anesthesia. Fetal safety was maintained, and no significant adverse outcomes were observed. This approach could offer an effective, minimally invasive alternative for managing acute cholecystitis in pregnant patients, reducing the need for more invasive surgical interventions. Larger, randomized studies are needed to confirm these findings and assess long-term outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e","manuscriptTitle":"The Efficacy and Safety of Performing Percutaneous Transhepatic Cholangioscopy (PTCS) Under Local Anesthesia for Pregnant Patient Suffering Acute Cholecystitis: A Study Protocol of a Prospective, Single-center, Single-arm Pilot Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-02-12 12:12:27","doi":"10.21203/rs.3.rs-5992794/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"b1781ac6-2434-423b-8e7a-7abe3222f863","owner":[],"postedDate":"February 12th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-05T16:55:10+00:00","versionOfRecord":[],"versionCreatedAt":"2025-02-12 12:12:27","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5992794","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5992794","identity":"rs-5992794","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}