Clinical trial NCT06340594: Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?
Official title: Single-stage Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choledocholithiasis With Cholecystitis
Biliary Stones
Keywords: Choledocholithiasis
ERCP
Laparoscopic cholecystectomy
Cholecystocholedocholithiasis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

* Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis

Exclusion Criteria:

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

Primary outcomes:
measure: Operative time operative time
timeFrame: time in minutes from intubation of the patient to the end of procedure
Secondary outcomes:
measure: CBD clearance rate
timeFrame: up to 2 years
measure: Length of hospital stay
timeFrame: up to 2 weeks post-operative
measure: Mortality rate
timeFrame: up to 1 month postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine-Assiut University -Assiut-Egypt
state: Asyut
Study officials:
References:
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.
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.
citation: 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.
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.
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.