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Completed

NCT Number: NCT06340594

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

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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Key information

Conditions

Choledocholithiasis With Cholecystitis Bile Duct Diseases Biliary Stones Biliary Tract Diseases Cholecystolithiasis Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Gallbladder Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine-Assiut University -Assiut-Egypt

Asyut, Asyut Governorate, 71515, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis

Exclusion criteria

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

Treatment and study plan

Laproscopic cholecystectomy (LC)

Procedure

Removal of gallbladder via laparoscopy

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Procedure

Removal of bile duct stones via endoscopy

Primary outcomes

  1. Operative time operative time

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

    total operative time of both ERCP+LC

Secondary outcomes

  1. CBD clearance rate

    Time frame: up to 2 years

    success rate of retrieval of stones

  2. Length of hospital stay

    Time frame: up to 2 weeks post-operative

    days of hospital stay

  3. Mortality rate

    Time frame: up to 1 month postoperative

    number of deaths intraoperative and postoperative related to surgery

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 1, 2024
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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