| CTRI Number |
CTRI/2024/10/075798 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sphincterotomy alone versus additional Balloon Dilatation for difficult choledocholithiasis |
|
Scientific Title of Study
|
Endoscopic sphincterotomy with large balloon dilatation (ESLBD) versus endoscopic sphincterotomy (ES) alone for predicted difficult choledocholithiasis: a randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Srivastava |
| Designation |
postdoctoral trainee Gastroenterology |
| Affiliation |
IPGMER and SSKM Hospital, Kolkata |
| Address |
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9472523778 |
| Fax |
|
| Email |
akansri2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshaunish Das |
| Designation |
Professor Department of Gastroenterology |
| Affiliation |
IPGMER and SSKM Hospital, Kolkata |
| Address |
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830349787 |
| Fax |
|
| Email |
dockdas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Srivastava |
| Designation |
postdoctoral trainee Gastroenterology |
| Affiliation |
IPGMER and SSKM Hospital, Kolkata |
| Address |
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9472523778 |
| Fax |
|
| Email |
akansri2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital Kolkata room no 24 Ronald ross IPGMER and SSKM Hospital AJC Bose Road Kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER and SSKM Hospital |
| Address |
Room no 24 4th floor Ronald ross building IPGMER and SSKM Hospital 244 AJC Bose road kolkata 700020 |
| Type of Sponsor |
Government medical college |
|
|
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 Akanksha Srivastava |
School of Digestive and liver disease IPGMER and SSKM Hospital |
ERCP suite , School of digestive liver disease building 4th floor IPGMER and SSKM Hospital 244 AJC Bose road kolkata 700020
Kolkata
WEST BENGAL |
9472523778
akansri2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research oversight committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K805||Calculus of bile duct without cholangitis or cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endoscopic Sphincterotomy Alone |
Biliary sphincterotomy will be extended to the full length of major duodenal papilla but not exceeding the major duodenal horizontal fold avoiding crossing the intramural part of the CBD. After ES Conventional extraction balloon trawled and the stone will be removed from the bile duct. Mechanical Lithotripsy will be used as rescue therapy . |
| Intervention |
Endoscopic Sphincterotomy With large Balloon Dilatation |
The length of the sphincterotomy will be limited to one third the length of sphincterotomy of ES alone group. EPLBD with a balloon catheter will be performed. The extent of balloon dilation can be from a minimum of 12mm to upto a maximum of 15mm depending upon the diameter of the proximal CBD. The balloon will be inflated for 15 to 30 seconds . After ESLBD conventional extraction balloon will be trawled and stone will be removed from the bile duct. Mechanical lithotrypsy will be used as rescue therapy . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults greater than 18 years old with radiologically ( Ultrasound and or MRCP) confirmed Choledocholithiasis of size equal to or greater than 10mm and or more than one in number undergoing ERCP for the first time
Ability to provide informed consent |
|
| ExclusionCriteria |
| Details |
Those with previous Biliary Sphincterotomy and or biliary stent in situ
Those with recurrent choledocholithiasis after previous endoscopic choledocholithiasis clearance
Patients having one or more choledocholithiasis with shortest transverse diameter greater than 15mm
Patients having impacted CBD calculus with relatively narrower CBD distal to the calculus on pre ERCP MRCP
Patients with Mirrizi syndrome
Patients with suspected biliary ascarisis
Patients having a stricture benign or malignant distal to the CBD calculus
Patients with ongoing Acute pancreatitis
Pancreatic head mass
Ongoing hypotension including those with sepsis
Patients with ongoing severe cholangitis as evidenced by the presence of one or greater organ dysfunction according to Tokyo guidelines
Pregnant women
Patients with significant renal illness like dialysis dependent
Patients with recent or past variceal bleeding uncontrolled ascites persistent hepatic encephalopathy and severe coagulopathy INR greater than 3
Patients with acute liver failure and or acute on chronic liver failure
Patients with recent Cerebrovascular accident and or Transient ischemic attack
Patients on anti coagulants and or clopidogrel that cannot be stopped temporarily
standard contraindications to ERCP
Unwillingness or inability to consent for the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Success rate defined as proportion of patients achieving complete removal of CBD calculus confirmed by cholangiogram at the end of the procedure |
end of procedure 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Complication rates Incidence of post procedural pancreatitis infections bleeding perforation and other adverse events
Procedure time Duration from successful deep cannulation of bile duct till procedure completion with bile duct clearance |
24 hours 48 hours 7 days 14 days |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dockdas@gmail.com].
- For how long will this data be available start date provided 04-12-2026 and end date provided 04-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
It is a Randomized controlled trial that will be conducted in the ERCP suite Division of Gastroenterology school of digestive and liver disease Institute of Post Graduate Medical Education and Research Kolkata India. This study will be an open label non inferiority parallel group 1:1 allocation randomized controlled clinical trial to assess the efficacy and safety of ESLBD versus ES for CBD clearance in patients with choledocholithiasis of size greater than 10mm and or greater or equal to 1 in number and undergoing index ERCP and it will be conducted in between October 2024 to March 2026. In each group sample size will be 54 making total of 108. Candidates will be selected as per Inclusion and exclusion criteria and will get randomized. After ES or ESLBD conventional extraction balloon trawled and stone will be removed from the bile duct. Mechanical lithotripsy will be used as rescue therapy in each group. Primary outcome of this study will be to determine Success rate that will be defined as per clearance achieved at the end of the procedure and secondary outcomes will be to know the incidence of post procedural complications in each group along with to determine the procedure time for each group. For the complications each individual will be followed for 24 hours 48 hours 7 days and 14 days. at the end of the study statistical analysis will be recorded in standard pre-defined proformas. Collected data will be entered in MS Excel sheet and analyzed by using SPSS statistics software. For analysis of categorical data chi square test will be used. For analysis of continuous variables Mann Whitney test will be used and for paired samples Wilcoxon rank sum test will be used. |