Cholelithiasis Associated With Common Bile Duct Stones
Conditions
Brief summary
This randomized controlled trial aims to compare the mean operative time and outcomes of early versus delayed laparoscopic cholecystectomy after ERCP in patients with cholelithiasis and choledocholithiasis. Patients will be randomized into two groups: early cholecystectomy (within 72 hours of ERCP) and delayed cholecystectomy (≥1 month after ERCP). Outcomes include operative time, intra-operative blood loss, hospital stay, and conversion to open cholecystectomy
Detailed description
Gallstones are among the most common surgical problems worldwide, and up to 20% of patients with gallstones also present with stones in the common bile duct. Standard care involves clearance of bile duct stones, typically by Endoscopic Retrograde Cholangiopancreaticography (ERCP), followed by removal of the gallbladder by laparoscopic cholecystectomy (LC). The timing of cholecystectomy after ERCP remains debated. Early LC (within 72 hours) has been associated with fewer recurrent biliary events, reduced hospital stay, and potentially easier operative conditions. However, delayed LC (after one month) continues to be widely practiced due to institutional factors and scheduling constraints. This randomized controlled trial at Sheikh Zayed Hospital, Lahore, is designed to evaluate whether early LC after ERCP offers measurable advantages compared with delayed LC. Patients with confirmed cholelithiasis and choledocholithiasis will be randomized into two groups: early surgery and delayed surgery. The trial will provide local evidence to guide surgical practice, focusing on operative efficiency and patient recovery. By clarifying the optimal timing of LC after ERCP in our patient population, the study aims to support evidence-based surgical decision-making, improve outcomes, and potentially reduce healthcare costs.
Interventions
PROCEDUREEarly laparoscopic cholecystectomy
Laparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy
PROCEDUREDelayed Laparoscopic cholecystectomy
Laparoscopic removal of gall bladder 2 weeks or more after successful ERCP
Sponsors
Rija Zainab
Shaikh Zayed Hospital, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment (Two arms, Early vs Delayed Laparoscopic cholecystectomy)
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with cholelithiasis with choledocholithiasis based on clinical and radiological findings (right subcostal pain, presence of gallstones, and dilated common bile duct on ultrasound and MRCP) * Age 14 to 70 years * Both males and females * Duration of symptoms less than 3 days * Presence of common bile duct stone with successful clearance on ERCP
Exclusion criteria
* Features suggestive of malignancy on imaging * Patients who develop severe pancreatitis after ERCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Operative time | During surgery | Duration of surgery measured from the first incision to closure of the last incision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | From admission to discharge (up to 30 days) | Total number of days from hospital admission to discharge. |
| Intraoperative Blood Loss | During Surgery | Blood loss measured in milliliters from suction apparatus during surgery. |
| Conversion to Open Cholecystectomy | During Surgery | Number of patients requiring conversion from laparoscopic to open surgery |
Countries
Pakistan
Contacts
CONTACTDr. Rija Zainab, MS General surgery
CONTACTDr. Muhammad Imran Anwar, FCPS, FRCS
PRINCIPAL_INVESTIGATORDr. Rija Zainab, MS General surgery
Shaikh Zayed Hospital, Lahore
Outcome results
None listed