| CTRI Number |
CTRI/2025/12/098589 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study To Compare Role of A Method To Reduce Complication After Pancreatic Surgery. |
|
Scientific Title of Study
|
Role of Afferent loop decompression in preventing Clinically Relevant Post Operative Pancreatic Fistula (CR-POPF) after Pancreaticoduodenectomy. |
| Trial Acronym |
POPF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipen Dineshbhai Patel |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical Sciences and SUM Hospital |
| Address |
Fourth Floor, Room No 5, Department of Surgical Gastroenterology, IMS and SUM Hospital, Kalinganagar, Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9429731649 |
| Fax |
|
| Email |
dipen2129@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyotirmay Jena |
| Designation |
Head of The Department |
| Affiliation |
Institute of Medical Sciences and SUM Hospital |
| Address |
Fourth Floor, Room No 2, Department of Surgical Gastroenterology, IMS and SUM Hospital, Kalinganagar, Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9861263696 |
| Fax |
|
| Email |
jyotirmay@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dipen Dineshbhai Patel |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical Sciences and SUM Hospital |
| Address |
Fourth Floor, Room No 5, Department of Surgical Gastroenterology, IMS and SUM Hospital, Kalinganagar, Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9429731649 |
| Fax |
|
| Email |
dipen2129@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences and SUM Hospital, K8 Kalinganagar, Bhubaneswar, Odisha - 751003 |
|
|
Primary Sponsor
|
| Name |
Dipen Dineshbhai Patel |
| Address |
IMS and SUM Hospital, K8 Kalinganagar, Bhubaneswar - 751003, Odisha, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dipen Dineshbhai Patel |
Institute of Medical Sciences and SUM Hospital |
Fourth Floor, Room No 5, Department of Surgical Gastroenterology, IMS and SUM Hospital, Kalinganagar, Bhubaneswar, Odisha
Khordha
ORISSA |
9429731649
dipen2129@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences(IMS) and SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Afferent loop decompression |
After Pancreaticoduodenectomy procedure during the reconstruction step: pancreaticojejunostomy, hepaticojejunostomy and gastrojejunostomy, A 16fr nasogastric tube(Ryle’s tube) is passed in the Afferent loop Intraoperatively during gastrojejunostomy and kept within 5-10 centimeters of hepaticojejunostomy. Serum and drain fluid amylase will be recorded on post operative day 1,3,5 and 7 as needed. RT will be under continuous drainage. PT will be started orally on POD 3 with RT in situ. RT will be removed once POPF resolve. |
| Comparator Agent |
Pancreaticoduodenectomy without afferent loop decompression. |
All steps are same except nasogastric tube is kept in stomach, and removed as oral diet starts. All tests are same for both group in post operative period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing Pancreaticoduodenectomy. |
|
| ExclusionCriteria |
| Details |
Age less than 18years.
Not willing to participate in study.
Additional procedure done along with Pancreaticoduodenectomy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Clinically Relevant Post Operative Pancreatic Fistula |
At Post Operative Day 3, Day 5, Day 7, and 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of post operative complications : Delayed Gastric Emptying, Post Pancreatectomy Hemorrhagic, Bile Leak, Surgical Site Infection |
At Post Operative Day 3, Day 5, Day 7, & 21 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
17/12/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Study title - Role of Afferent loop decompression in preventing Clinically Relevant Post Operative Pancreatic Fistula (CR-POPF) after Pancreaticoduodenectomy. Pancreaticoduodenectomy (PD), commonly known as the Whipple procedure, is widely considered the definitive surgical treatment for tumors arising from the periampullary region. POPF remains the most impactful complication following Pancreaticoduodenectomy. CR-POPF occurs in approximately 10% to 30% of cases, with its likelihood influenced by both patient-related and intraoperative variables. Exciting strategies to reduce CR-POPF have limited effectiveness or require expensive adjuncts. Intraluminal pressure is a modifiable factor with strong physiologic link to POPF. Afferent loop decompression is a simple, reproducible and low cost intervention with limited data on effectiveness in preventing CR-POPF. Our study aims to determine incidence of CR-POPF in patients with Afferent Loop decompression in Pancreaticoduodenectomy compared to standard technique and to determine whether ALD is an effective strategy to decrease burden of CRPOPF.
|