Modified Laparoendoscopic Rendezvous for Secondary Choledocholithiasis: a Nonrandomized Controlled Clinical Study

Choledocholithiasis Clinical Trial

Official title:

Modified Laparoendoscopic Rendezvous for Secondary Choledocholithiasis: a Nonrandomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542784
• Other study ID #: 20223357016
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2022
• Source: Shenzhen Second People's Hospital
• Contact: Yongqiang Zhan, Chief physician
• Phone: 13714096676
• Email: yqzhan[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Patients with cholecystolithiasis secondary to common bile duct stones requiring surgical treatment during a 3-year period from 2022-6-1 to 2025-3-31 were enrolled in this non-randomized controlled clinical trial. Preoperative diameter of the middle common bile duct was determined by magnetic resonance cholangiography (MRCP) or B-ultrasound measurement. The actual treatment plan of the patients was recorded, including LERV treatment and ERCP+LC treatment. The baseline data and the success rate of stone removal, operation time, postoperative stone residual rate, complication rate, length of hospital stay and hospitalization cost were recorded for observation and follow-up. To determine whether modified LERV can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1?18 years = age <85 years 2?clinical diagnosis of choledocholithiasis secondary to cholecystolithiasis and middle choledocholithiasis (MCBD) diameter =10mm; The diameter of MCBD was based on MRCP measurements. If MRCP could not be performed, CT images were used as reference, and B-ultrasound measurements were used as the standard.

3? Good cardiopulmonary function, anesthesia evaluation tolerance under general anesthesia laparoscopic + endoscopic surgery.

-

Exclusion Criteria:

1? Intrahepatic bile duct stones with indications for surgery, and need simultaneous surgery; 2? Patients with choledocholithiasis >2 cm or a large number of stones were difficult to remove; 3? Patients with malignant hepatobiliary and pancreatic tumors or biliary tract malformations; 4? Severe patients with severe pancreatitis and septic shock before operation; 5?Patients with previous gastric and duodenoscopic surgery history and interruption of gastroduodenal continuity; 6? Severe partial stenosis of the upper gastrointestinal tract (from the oral cavity to the second duodenum), which is expected to be inaccessible to the duodenoscope.

-

Related Conditions & MeSH terms

• Choledocholithiasis

Intervention

Procedure:
• Modified LERV
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.

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (16)

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, Th — View Citation

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-2 — View Citation

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. Review — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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/s005 — View Citation

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. — View Citation

Noel R, Enochsson L, Swahn F, Löhr 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. d — View Citation

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. 20 — View Citation

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 Syst — View Citation

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 manageme — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness evaluation index	Success rate of stone removal (as judged by ERCP imaging)	intraoperative
Secondary	Postoperative related clinical indicators	The incidence of PEP	Blood routine, pancreatic enzyme binomial and liver function were examined on the first and second day after operation.
Secondary	The hospital indicators	Length of hospital stay after operation (including operation day), hospitalization cost after operation (including operation day)	an average 1 week
Secondary	the incidence of serious complications	including duodenal papilla hemorrhage, duodenal perforation, acute pancreatitis, duodenal leakage (fistula), abdominal abscess, the incidence of hyperamylasemia, the incidence of residual common bile duct stones, etc.	Within 1 year