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CompletedNCT06340594Updated Apr 2, 2024

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

An observational study in Choledocholithiasis With Cholecystitis and Biliary Stones, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
115
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Choledocholithiasis With Cholecystitis
  • Biliary Stones

Keywords

  • Choledocholithiasis
  • ERCP
  • Laparoscopic cholecystectomy
  • Cholecystocholedocholithiasis
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In context

Cholecystolithiasis

88 studies on the registry are indexed under Cholecystolithiasis; 17 are open to participants now.

This study's enrollment of 115 is below the median of 341 across 28 observational studies indexed under Cholecystolithiasis.

Browse Cholecystolithiasis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis

Exclusion criteria

Exclusion Criteria:

  • to ERCP, or laparoscopic surgery
  • Cholangitis and pancreatitis
  • Previously failed ERCP
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
115 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureLaproscopic cholecystectomy (LC)

    Removal of gallbladder via laparoscopy

  • ProcedureEndoscopic Retrograde Cholangiopancreatography (ERCP)

    Removal of bile duct stones via endoscopy

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What researchers measure

Primary outcomes

  1. Operative time operative time

    total operative time of both ERCP+LC

    Time frame: time in minutes from intubation of the patient to the end of procedure

Secondary outcomes

  1. CBD clearance rate

    success rate of retrieval of stones

    Time frame: up to 2 years

  2. Length of hospital stay

    days of hospital stay

    Time frame: up to 2 weeks post-operative

  3. Mortality rate

    number of deaths intraoperative and postoperative related to surgery

    Time frame: up to 1 month postoperative

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Study locations

1 site
  • Faculty of Medicine-Assiut University -Assiut-Egypt
    Assiut, Asyut 71515, Egypt
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References and documents

Publications

  • 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. PubMed 20083751 ↗
  • 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. PubMed 32105889 ↗
  • 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. PubMed 27334962 ↗
  • 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. PubMed 18321943 ↗
  • 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. PubMed 36816010 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06340594
Lead sponsor
Assiut University
Responsible party
Mohamad Raafat (Lecturer at General surgery department, Assiut University) — Principal investigator
First posted
Apr 1, 2024
Start date
Jan 1, 2021
Primary completion
Dec 1, 2023
Completion
Jan 30, 2024
Last update
Apr 2, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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