Gallbladder and Bile Duct Calculi
Conditions
Keywords
time of cholecystectomy after ERCP
Brief summary
Approximately 10-15% of all patients with gallstones have coexisting common bile duct (CBD) stones. However CBD stones can also be formed in the absence of gallbladder stones. The current standard of treatment for calcular obstructive jaundice is endoscopic removal of the stones. Endoscopic sphincterotomy (ES) is widely accepted as the treatment of choice for patients with CBDS. Stone extraction is successful in up to 97% of patients The time interval between ERCP and laparoscopic cholecystectomy (LC) is a matter of debate that may vary from days to months. Some retrospective and other prospective studies have investigated this issue without sharp clue or definite conclusion This study planned to compare early LC (within admission) versus late LC (after 1 month) after ERCP as regard technical difficulties and surgical outcomes.
Detailed description
The aim is comparing early versus delayed laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography in patients with gall bladder stones and calcular obstructive jaundice as regards operative difficulties, conversion rate, signs of inflammation, degree of adhesions, blood loss, postoperative morbidity, and hospital stay. Moreover, bacterial examination of bile and culture sensitivity test for assessment of bacterial colonization and relate the degree of colonization to timing of laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography, to decide upon the optimal timing for the surgery. The study population will be divided into 2 groups; group (A) will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP and group (B) will be managed by late LC one month after ERCP.
Interventions
PROCEDUREearly cholecystectomy
Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 1 will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP
PROCEDURElate cholecystectomy
Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 2 will be managed by late LC one month after ERCP.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with CBD stone and treated by ERCP
Exclusion criteria
* Patient unfit for surgery, * Pregnant patients, * Patients with severe malnutrition, * Patients with liver cirrhosis, * Patients in whom endoscopic management of CBD stones failed * Patients who experienced pancreatitis or perforation as a complication of the endoscopic management of CBD stones * Patients who underwent previous upper abdominal surgeries * Mentally retarded patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| conversion rate to open | 1 day | number of patients underwent conversion to open |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| signs of inflammation (redness, pus) | 30 days | signs of inflammation redness, pus, wall thickness |
| postoperative morbidity | 1 days | postoperative morbidity |
| degree of adhesion (mild,moderate, severe) | 1 days | degree of adhesions |
Outcome results
None listed