Appropriate timing of Laparoscopic Cholecystectomy after tackling CBD stones via ERCP
- Conditions
- Calculus of bile duct with cholecystitis, (2) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (3) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (4) ICD-10 Condition: K805||Calculus of bile duct without cholangitis or cholecystitis,
- Registration Number
- CTRI/2019/07/020262
- Lead Sponsor
- Dr Pavan Madhukar Bhat nil expense
- Brief Summary
Laparoscopic cholecystectomy preceded by pre-operative ERCP remains the cornerstone and most commonly practiced strategy worldwide for management of co-existing gallbladder and CBD stones.However there is difference in opinion as to the time interval between performing the two procedures. There is a surgeon-to-surgeon difference in preferences with various factors coming into play.
Purpose of trial: This study is to analyse the various factors that impact this decision and to conclude if performing the surgery early(within 48 hours) is better or late(after 6 weeks)
Major drawback of delaying Laparoscopic Cholecystectomy are high incidence of biliary complications like bile spill, stone spill and occurence of intra-operative adhesions.
Major drawbacks of early Laparoscopic Cholecystectomy is difficult handling of structures that are in a setting of ongoing inflammation.
This study is to analyse the benefits and disadvantages of each approach from both
1. Surgeon’s point of view- Duration of surgery, Intra-op adhesions, intra / post-op complications
2. Patient’s point of view- Hospital stay, cost profile
Methodology-
Retrospective samples -
1. Patients who underwent ERCP for choledocholithiasis (under Department of Gastroenterology) followed by laparoscopic cholecystectomy (under the Department of General Surgery) in Kasturba Hospital, Manipal will be included in the study after fulfilling the inclusion and exclusion criteria.
2. Requisite pre-op laboratory values, intra-op op & post-operative parameters will be noted from the patient’s medical records.
Prospective samples-
1. Patients satisfying inclusion criteria will be chosen by closely following the ERCP list performed by Gastroenterology.
2. Patients among these who are then referred to General Surgery department for Post-ERCP Laparoscopic Cholecystectomy will be decided for early or late Laparoscopic Cholecystectomy based on
surgeon’s preference.
3. At this point, informed consent will be taken from the patient to include them in the study.
4. Pre-op- Lab values will be noted. - Total leukocyte count, Total & Direct Bilirubin, Liver enzymes
5. Intra-op- Operation will be observed for - duration of surgery, status of calot’s triangle, intra-abdominal adhesions
6. Post-op- Patient will be followed up on a daily basis to note - bile leak, surgical site infection, sepsis
7. Total hospital stay & costs incurred to patient will be noted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- Documented radiological evidence of choledocholithiasis.
- Management of CBD Stones with ERCP.
- Carcinoma of Gall Bladder 2.
- Previous abdominal surgeries.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the appropriate time at which cholecystectomy should be done post ERCP. within 48 hours or after 6 weeks
- Secondary Outcome Measures
Name Time Method To analyse how the time gap between ERCP and cholecystectomy affects the duration of surgery. To evaluate if there is a higher conversion rate of laparoscopic cholecystectomy to open cholecystectomy with the increasing duration of To assess the duration of hospital stay, outcome, complications, cost profile in both set of patients.
Trial Locations
- Locations (1)
Kasturba Medical College & Hospital
🇮🇳Udupi, KARNATAKA, India
Kasturba Medical College & Hospital🇮🇳Udupi, KARNATAKA, IndiaDr Pavan Madhukar BhatPrincipal investigator9731243720pavanbhat76@gmail.com