Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?

Biliary Stones Clinical Trial

Official title:

Single-stage Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06340594
• Other study ID #: RF-2-2024
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: January 30, 2024
• Est. primary completion date: December 1, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis

Exclusion Criteria:

• Contraindications to ERCP, or laparoscopic surgery
• Cholangitis and pancreatitis
• Previously failed ERCP

Related Conditions & MeSH terms

• Biliary Stones
• Cholecystitis
• Cholecystolithiasis
• Choledocholithiasis
• Choledocholithiasis With Cholecystitis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Laproscopic cholecystectomy (LC)
Removal of gallbladder via laparoscopy
• Endoscopic Retrograde Cholangiopancreatography (ERCP)
Removal of bile duct stones via endoscopy

Locations

Country	Name	City	State
Egypt	Faculty of Medicine-Assiut University -Assiut-Egypt	Assiut	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Elgeidie A, Atif E, Elebidy G. Intraoperative ERCP for management of cholecystocholedocholithiasis. Surg Endosc. 2017 Feb;31(2):809-816. doi: 10.1007/s00464-016-5036-1. Epub 2016 Jun 22. — View Citation

Muhammedoglu B, Kale IT. Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to-eight weeks later: A randomized controlled trial. Int J Surg. 2020 Apr;76:37-44. doi: 10.1016/j.ijsu.2020.02.021. Epub 2020 Feb 24. — View Citation

Nie S, Fu S, Fang K. Comparison of one-stage treatment versus two-stage treatment for the management of patients with common bile duct stones: A meta-analysis. Front Surg. 2023 Feb 3;10:1124955. doi: 10.3389/fsurg.2023.1124955. eCollection 2023. — View Citation

Rogers SJ, Cello JP, Horn JK, Siperstein AE, Schecter WP, Campbell AR, Mackersie RC, Rodas A, Kreuwel HT, Harris HW. Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease. Arch Surg. 2010 Jan;145(1):28-33. doi: 10.1001/archsurg.2009.226. — View Citation

Williams EJ, Green J, Beckingham I, Parks R, Martin D, Lombard M; British Society of Gastroenterology. Guidelines on the management of common bile duct stones (CBDS). Gut. 2008 Jul;57(7):1004-21. doi: 10.1136/gut.2007.121657. Epub 2008 Mar 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time operative time	total operative time of both ERCP+LC	time in minutes from intubation of the patient to the end of procedure
Secondary	CBD clearance rate	success rate of retrieval of stones	up to 2 years
Secondary	Length of hospital stay	days of hospital stay	up to 2 weeks post-operative
Secondary	Mortality rate	number of deaths intraoperative and postoperative related to surgery	up to 1 month postoperative