| CTRI Number |
CTRI/2021/02/031004 [Registered on: 04/02/2021] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Therapeutic Endoscopy (ERCP)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised trial to study the effect of precut techniques as primary modality on post ERC pancreatitis (PEP) rate among those who come under high risk for PEP |
|
Scientific Title of Study
|
A randomized trial to study the effect of primary precut papillotomy versus primary precut fistulotomy on post ERC pancreatitis (PEP) rate among high risk cohort for PEP |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NK/6772/Study/696 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshal S Mandavdhare |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Department of Gastroenterology, Ground floor, F block, Nehru Hospital, PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592814877 |
| Fax |
|
| Email |
hmandavdhare760@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harshal S Mandavdhare |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Department of Gastroenterology, Ground floor, F block, Nehru Hospital, PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592814877 |
| Fax |
|
| Email |
hmandavdhare760@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshal S Mandavdhare |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Department of Gastroenterology, Ground floor, F block, Nehru Hospital, PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592814877 |
| Fax |
|
| Email |
hmandavdhare760@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
PGIMER |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Harshal S Mandavdhare |
PGIMER |
Dept of Gastroenterology
Chandigarh
CHANDIGARH |
9592814877
hmandavdhare760@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K831||Obstruction of bile duct, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Primary precut fistulotomy |
In this group, we will start ERC upfront by performing primary precut fistulotomy without attempting standard cannulation method. This will be done with the help of needle knife (Microknife XL, Boston Scientific, USA) preloaded with guidewire by performing a linear free hand cut (ENDOcut I mode-effect 2, watt-60, ERBE, Tubingen, Germany) on to the ampullary bulge 3-4 mm separate from the papillary orifice and then deepening the cut in a stepwise manner till we reach the whitish muscle layer of the lower end of common bile duct (CBD). Once the muscle layer is reached a further deep cut will be giving after which wire will be advanced under the fluoroscopic guidance. Once the wire is seen going into the liver, selective biliary cannulation will be confirmed by water soluble contrast cholangiogram. |
| Comparator Agent |
Primary precut papillotomy |
In this group, we will start ERC by performing primary precut papillotomy without attempting standard cannulation method. This will be done with the help of needle knife (Microknife XL, Boston Scientific, USA) preloaded with guidewire by performing a linear free hand cut (ENDOcut I mode-effect 2, watt-60, ERBE, Tubingen, Germany) starting from the upper margin of the papillary orifice and positioning the needle at the upper margin and giving a linear cut in below upward fashion of around 2-3 mm and then deepening the cut in a stepwise manner till we reach the whitish muscle layer of the lower end of common bile duct (CBD). Once the muscle layer is reached a further deep cut will be giving after which wire will be advanced under the fluoroscopic guidance. Once the wire is seen going into the liver, selective biliary cannulation will be confirmed by water soluble contrast cholangiogram. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing ERC and come under high risk group for development of PEP will be randomised into either primary precut fistulotomy or paplillotomy groups |
|
| ExclusionCriteria |
| Details |
1-Previous sphincterotomy
2-Severe coagulopathy (INR>1.5)
3-Suspected periampullary growth
4-Distorted anatomy-Billroth II surgery
5-Small flat papilla
6-Periampullary diverticulum other than type III
7-Pancreatitis (Acute/chronic)
8- Unwilling to give informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of primary PP with primary PF on PEP rate in high risk cohort for PEP |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-Compare the success rate of selective biliary cannulation (SBC)
2-Compare the rate of other ERC related complications
3-Compare the total procedure time (starting from precut to successful SBC)
4-Need for other interventions
5-Compare the rate of hyperamylasemia |
3 days |
|
|
Target Sample Size
|
Total Sample Size="324"
Sample Size from India="324"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="324" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2021 |
| Date of Study Completion (India) |
10/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
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
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hmandavdhare760@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
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
|
Post ERCP pancreatitis (PEP) is the most common and worrisome complication of ERCP with an incidence ranging from 3.5-9.7%. Among the high-risk group for PEP the incidence reported is around 14.7%. As per ESGE guidelines 2020 a patient is considered to be high risk for PEP in presence of at least 1 definite or 2 likely patient /procedure related risk factors. A recent multicenter randomized trial has shown very good efficacy and safety of primary precut fistulotomy in high risk cohort for PEP. Another randomized trial compared very early precut papillotomy (PP) with primary PP. The primary PP group had only 1 case of PEP (0.67%), suggesting good safety of the primary PP approach, although the very early group had PEP rate of 5.2%, same as has been reported in standard cannulation. In the second study the PP was done in average risk patients and even among them the PEP rate in the very early group was 5.2%. We do not know what is role of primary PP in high risk cohort for PEP, hence, we planned this randomized trial to compare the effect of primary PP with primary PF on PEP rate in high risk cohort for PEP. |