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

NCT06340594 | Completed

• 1 other identifier: RF-2-2024
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Choledocholithiasis With Cholecystitis; Biliary Stones

Keywords

Choledocholithiasis; ERCP; Laparoscopic cholecystectomy; Cholecystocholedocholithiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• CBD clearance rate

  up to 2 years

• Length of hospital stay

  up to 2 weeks post-operative

• Mortality rate

  up to 1 month postoperative

Study Arms (2)

Group A (ERCP 1st approach)

The patients first underwent ERCP followed by standard 4 port LC.

Procedure: Laproscopic cholecystectomy (LC); Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

Group B (LC 1st approach)

The patients first underwent LC followed by ERCP.

Procedure: Laproscopic cholecystectomy (LC); Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

Interventions

Laproscopic cholecystectomy (LC) PROCEDURE

Removal of gallbladder via laparoscopy

Group A (ERCP 1st approach); Group B (LC 1st approach)

Endoscopic Retrograde Cholangiopancreatography (ERCP) PROCEDURE

Removal of bile duct stones via endoscopy

Group A (ERCP 1st approach); Group B (LC 1st approach)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic calculous cholecystitis associated with common bile duct (CBD) stones admitted in a tertiary care hospital

You may qualify if:

• Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine-Assiut University -Assiut-Egypt

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (5)

• 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.

  PMID: 20083751 BACKGROUND

• 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.

  PMID: 32105889 BACKGROUND

• 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.

  PMID: 27334962 BACKGROUND

• 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.

  PMID: 18321943 BACKGROUND

• 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.

  PMID: 36816010 BACKGROUND

MeSH Terms

Conditions

Cholecystolithiasis; Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Common Bile Duct Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at General surgery department

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: January 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 30, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)