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

NCT ID: NCT06340594

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Choledocholithiasis With Cholecystitis Biliary Stones

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A (ERCP 1st approach)

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

Laproscopic cholecystectomy (LC)

Intervention Type PROCEDURE

Removal of gallbladder via laparoscopy

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Intervention Type PROCEDURE

Removal of bile duct stones via endoscopy

Group B (LC 1st approach)

The patients first underwent LC followed by ERCP.

Laproscopic cholecystectomy (LC)

Intervention Type PROCEDURE

Removal of gallbladder via laparoscopy

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Intervention Type PROCEDURE

Removal of bile duct stones via endoscopy

Interventions

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Laproscopic cholecystectomy (LC)

Removal of gallbladder via laparoscopy

Intervention Type PROCEDURE

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Removal of bile duct stones via endoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis

Exclusion Criteria

* Contraindications to ERCP, or laparoscopic surgery
* Cholangitis and pancreatitis
* Previously failed ERCP
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamad Raafat

Lecturer at General surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine-Assiut University -Assiut-Egypt

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 20083751 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32105889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27334962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18321943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36816010 (View on PubMed)

Other Identifiers

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RF-2-2024

Identifier Type: -

Identifier Source: org_study_id

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