| CTRI Number |
CTRI/2019/07/020262 [Registered on: 19/07/2019] Trial Registered Prospectively |
| Last Modified On: |
18/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Appropriate timing of Laparoscopic Cholecystectomy after tackling CBD stones via ERCP |
|
Scientific Title of Study
|
Early Versus Delayed Laparoscopic Cholecystectomy after
management of Choledocholithiasis with Endoscopic Retrograde Cholangio
Pancreatography (ERCP) - A Comparative Study |
| Trial Acronym |
ERCPLAPCHOLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavan Madhukar Bhat |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery
Room no. 19, 3rd Floor,
New OPD Block,
Kasturba Medical College,
Manipal
SUMUKH
Door no. 2-1-95-c/2
Behind Dr. R.N.Bhats compound
Gundibail,Udupi
Karnataka 576102
Udupi
KARNATAKA
576104
India |
| Phone |
9731243720 |
| Fax |
|
| Email |
pavanbhat76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh BV |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery,
Room no. 19, 3rd Floor,
New OPD Block,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9731243720 |
| Fax |
|
| Email |
surgery1.kmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavan Madhukar Bhat |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery
Room no. 19, 3rd Floor,
New OPD Block,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9731243720 |
| Fax |
|
| Email |
pavanbhat76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Pavan Madhukar Bhat (nil expense)
Department of General Surgery, Room no.19, 3rd Floor, New OPD Block, Kasturba Hospital, Manipal, Udupi-576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Pavan Madhukar Bhat nil expense |
| Address |
SUMUKH, DOOR NO.2-1-95-C/2, GUNDIBAIL, UDUPI 576102, KARNATAKA |
| Type of Sponsor |
Other [SELF- NO EXPENSE] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pavan Madhukar Bhat |
Kasturba Medical College & Hospital |
Department of General Surgery
3rd floor New OPD Block
Kasturba Hospital
Madhav Nagar
Manipal 576104
Udupi
KARNATAKA |
9731243720
pavanbhat76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K804||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, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Documented radiological evidence of choledocholithiasis.
2. Management of CBD Stones with ERCP |
|
| ExclusionCriteria |
| Details |
1. Carcinoma of Gall Bladder
2. Previous abdominal surgeries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the appropriate time at which cholecystectomy should be done post ERCP. |
within 48 hours or after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the duration of hospital stay, outcome, complications, cost
profile in both set of patients. |
within 48 hours or after 6 weeks |
To analyse how the time gap between ERCP and cholecystectomy affects
the duration of surgery. |
within 48 hours or after 6 weeks |
To evaluate if there is a higher conversion rate of laparoscopic
cholecystectomy to open cholecystectomy with the increasing duration of
time after ERCP. |
within 48 hours or after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |