NCT05542784|Unknown
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Sponsor study identifier
observational
90
1 country
1
Study Start
June 1, 2022
Actual (reported)Primary Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study intends to explore the success rate and clinical efficacy of modified LERV in the treatment of patients with non-dilated common bile duct (internal diameter ≤10mm) through a non-randomized controlled clinical trial, and to clarify whether modified LERV can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2022
Actual (reported)July 29, 2022
Actual (reported)September 15, 2022
Actual (reported)March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Effectiveness evaluation index
Success rate of stone removal (as judged by ERCP imaging)
intraoperative
Postoperative related clinical indicators
Blood routine, pancreatic enzyme binomial and liver function were examined on the first and second day after operation.
The hospital indicators
an average 1 week
the incidence of serious complications
Within 1 year
Patients routinely underwent LC. The ligature clamp clamps the distal end of the capsule tube. In this case, you need to perform two steps: Laparoscopic operation: proximal incision, anterograde placement of guide wire into the duodenum. The catheter was removed and the balloon dilated. The balloon was released and removed when the ERCP was initiated for cannulation. After successful ERCP retrograde placement, the anterograde guide wire was pulled out and the gallbladder was removed. ERCP procedure: After the anterograde guide wire was observed by duodenoscope, duodenal papilla was placed through a retrograde incision along the anterograde guide wire, and a retrograde cannula was inserted into the common bile duct. Remove stones by dragging them with a net basket or/and balloon. Angiography confirmed that there was no filling defect in the extrahepatic bile duct, and ENBD was indwelled.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients aged 18 to 85 years with common bile duct stones who are suitable for and consent to undergo laparoscopic plus endoscopic surgery under general anesthesia
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Tazuma S. Gallstone disease: Epidemiology, pathogenesis, and classification of biliary stones (common bile duct and intrahepatic). Best Pract Res Clin Gastroenterol. 2006;20(6):1075-83. doi: 10.1016/j.bpg.2006.05.009.
Bradley A, Sami S, Hemadasa N, Macleod A, Brown LR, Apollos J. Decision analysis of minimally invasive management options for cholecysto-choledocholithiasis. Surg Endosc. 2020 Dec;34(12):5211-5222. doi: 10.1007/s00464-020-07816-w. Epub 2020 Jul 24.
Zibing Fan, Attending physician
Shenzhen Second People's Hospital
Ganchen Sun, Nurse practitioner
Shenzhen Second People's Hospital
Yanan Bao, nurse-in-charge
Shenzhen Second People's Hospital
Xuelin Liu, Nurse practitioner
Shenzhen Second People's Hospital
First Submitted
July 29, 2022
First Posted
September 15, 2022
Study Start
June 1, 2022
Actual (reported)Primary Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Comparison of LCBDE vs ERCP + LC for Choledocholithiasis
Contact the study team to confirm eligibility.
Deslandres E, Gagner M, Pomp A, Rheault M, Leduc R, Clermont R, Gratton J, Bernard EJ. Intraoperative endoscopic sphincterotomy for common bile duct stones during laparoscopic cholecystectomy. Gastrointest Endosc. 1993 Jan-Feb;39(1):54-8. doi: 10.1016/s0016-5107(93)70011-5. No abstract available.
Liu W, Wang Q, Xiao J, Zhao L, Huang J, Tan Z, Li P. A modified technique reduced operative time of laparoendoscopic rendezvous endoscopic retrograde cholangiopancreatography combined with laparoscopic cholecystectomy for concomitant gallstone and common bile ductal stone. Gastroenterol Res Pract. 2014;2014:861295. doi: 10.1155/2014/861295. Epub 2014 Jun 15.
Mine T, Morizane T, Kawaguchi Y, Akashi R, Hanada K, Ito T, Kanno A, Kida M, Miyagawa H, Yamaguchi T, Mayumi T, Takeyama Y, Shimosegawa T. Clinical practice guideline for post-ERCP pancreatitis. J Gastroenterol. 2017 Sep;52(9):1013-1022. doi: 10.1007/s00535-017-1359-5. Epub 2017 Jun 26.
Bailey AA, Bourke MJ, Williams SJ, Walsh PR, Murray MA, Lee EY, Kwan V, Lynch PM. A prospective randomized trial of cannulation technique in ERCP: effects on technical success and post-ERCP pancreatitis. Endoscopy. 2008 Apr;40(4):296-301. doi: 10.1055/s-2007-995566.
Cotton PB, Garrow DA, Gallagher J, Romagnuolo J. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc. 2009 Jul;70(1):80-8. doi: 10.1016/j.gie.2008.10.039. Epub 2009 Mar 14.
ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.
Noel R, Enochsson L, Swahn F, Lohr M, Nilsson M, Permert J, Arnelo U. A 10-year study of rendezvous intraoperative endoscopic retrograde cholangiography during cholecystectomy and the risk of post-ERCP pancreatitis. Surg Endosc. 2013 Jul;27(7):2498-503. doi: 10.1007/s00464-012-2768-4. Epub 2013 Jan 26.
Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
Pan L, Chen M, Ji L, Zheng L, Yan P, Fang J, Zhang B, Cai X. The Safety and Efficacy of Laparoscopic Common Bile Duct Exploration Combined with Cholecystectomy for the Management of Cholecysto-choledocholithiasis: An Up-to-date Meta-analysis. Ann Surg. 2018 Aug;268(2):247-253. doi: 10.1097/SLA.0000000000002731.
Ricci C, Pagano N, Taffurelli G, Pacilio CA, Migliori M, Bazzoli F, Casadei R, Minni F. Comparison of Efficacy and Safety of 4 Combinations of Laparoscopic and Intraoperative Techniques for Management of Gallstone Disease With Biliary Duct Calculi: A Systematic Review and Network Meta-analysis. JAMA Surg. 2018 Jul 18;153(7):e181167. doi: 10.1001/jamasurg.2018.1167. Epub 2018 Jul 18.
Tan C, Ocampo O, Ong R, Tan KS. Comparison of one stage laparoscopic cholecystectomy combined with intra-operative endoscopic sphincterotomy versus two-stage pre-operative endoscopic sphincterotomy followed by laparoscopic cholecystectomy for the management of pre-operatively diagnosed patients with common bile duct stones: a meta-analysis. Surg Endosc. 2018 Feb;32(2):770-778. doi: 10.1007/s00464-017-5739-y. Epub 2017 Jul 21.
Tse F, Yuan Y, Moayyedi P, Leontiadis GI. Guide wire-assisted cannulation for the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis. Endoscopy. 2013 Aug;45(8):605-18. doi: 10.1055/s-0032-1326640. Epub 2013 Jun 27.
Morino M, Baracchi F, Miglietta C, Furlan N, Ragona R, Garbarini A. Preoperative endoscopic sphincterotomy versus laparoendoscopic rendezvous in patients with gallbladder and bile duct stones. Ann Surg. 2006 Dec;244(6):889-93; discussion 893-6. doi: 10.1097/01.sla.0000246913.74870.fc.
Tatulli F, Cuttitta A. Laparoendoscopic approach to treatment of common bile duct stones. J Laparoendosc Adv Surg Tech A. 2000 Dec;10(6):315-7. doi: 10.1089/lap.2000.10.315.
Haoyuan Deng, Attending physician
Shenzhen Second People's Hospital
Yifan Zhang, Master's Degree student
Shenzhen Second People's Hospital
Yang Li, Nurse practitioner
Shenzhen Second People's Hospital
Haoran Ma, Nurse practitioner
Shenzhen Second People's Hospital
Naiyang Zhan, Attending physician
Shenzhen Second People's Hospital
Yiyuan Chen, Master's Degree student
Shenzhen Second People's Hospital
Study Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 15, 2022
Record last verified: 2022-05
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