Does Early Laparoscopic Cholecystectomy After ERCP Reduce the Risk of Complications

NCT06311305 | Recruiting DMC

• 1 other identifier: Soh-med-24-03-07MS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985. The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and nucleation. Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being more common occurs due to stones originating in gallbladder and then migrating through cystic duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in Asian populations. These stones are associated with biliary stasis and bacteria.

Conditions

Cholelithiases

Keywords

ERCP; Laparoscopic; cholecystectomy; Gallstones

Outcome Measures

Primary Outcomes (4)

• bile leakage

  yes or no

  2 weeks postoperative

• operative time

  in hours

  intraoperative

• intraoperative bleeding

  in cubic centimeters

  intraoperative

• sepsis

  yes or no

  2 weeks postoperative

Study Arms (1)

early laparoscopic cholecystectomy after ERCP

OTHER

we assess the risks and complications of early laparoscopic cholecystectomy after ERCP

Procedure: Early Laparoscopic cholecystectomy

Interventions

Early Laparoscopic cholecystectomy PROCEDURE

laparoscopic cholecystectomy early after ERCP with assessing the risks and complications

Also known as: laparoscopic cholecystectomy

early laparoscopic cholecystectomy after ERCP

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients post ERCP with gall stone.
• Age 15-70
• Gender female and male patient.

You may not qualify if:

• Post ERCP pancreatitis
• Septicemia
• Hepatocellular jaundice and End stage liver disease
• Patient who didn't give informed consent.
• Patients who refused laparoscopic cholecystectomy.
• Patients who were not fit for general anesthesia due to various medical illnesses.
• ERCP for reasons other than stone disease,
• Contraindications to Laparoscopic cholecystectomy like: Cardiovascular andpulmonary disease, coagulopathies and end-stage liver disease (ESLD).
• Patients with Carcinoma Gall bladder, Common bile duct strictures, Coagulopathy, previous upper abdominal surgeries

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Cholelithiasis; Gallstones

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Central Study Contacts

Abdulla M Ahmed, Master

CONTACT

01099696698; abdallah_mohamed_ex@med.sohag.edu.eg

Abdulla M Ahmed, Master

CONTACT

01099696698; farragmostafa50@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: NONE (open label single group)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Abdulla Mohammed Ahmed Hussein

Model Details: we aim to assess if the early laparoscopic cholecystectomy after ERCP can reduce the risks or complications

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 20, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)