| CTRI Number |
CTRI/2025/07/090669 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Efficacy of Surgical intervention over Percutaneous drainage in Infected Pancreatic Necrosis |
|
Scientific Title of Study
|
Efficacy of Video-Assisted Retroperitoneal Debridement (VARD) Over Radiological Percutaneous Interventions (RPI) in the Management of Infected Pancreatic Necrosis:An Open Labelled 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 |
DrRishit Mani |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Room 410 Surgical Gastroenterology OPD ,4th floor OPD Building,AIIMS Patna,Patna
Patna BIHAR 801507 India |
| Phone |
9939548239 |
| Fax |
|
| Email |
rishitmani@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrUtpal Anand |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Room 410 Surgical Gastroenterology OPD ,4th floor OPD Building,AIIMS Patna,Patna
Patna BIHAR 801507 India |
| Phone |
9661507725 |
| Fax |
|
| Email |
utpalanand2@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrUtpal Anand |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Room 410 Surgical Gastroenterology OPD ,4th floor OPD Building,AIIMS Patna,Patna
Patna BIHAR 801507 India |
| Phone |
9661507725 |
| Fax |
|
| Email |
utpalanand2@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Patna,Near AIIMS Golambar,Phulwarisharif,801507,Patna,Bihar,India |
|
|
Primary Sponsor
|
| Name |
Dr Rishit Mani |
| Address |
4th floor Surgical Gastroenterology OPD,OPD building,AIIMS Patna |
| Type of Sponsor |
Other [by 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 |
| Dr Rishit Mani |
AIIMS Patna |
Room 410 Surgical Gastroenterology OPD ,4th floor OPD Building,AIIMS Patna,Patna Patna BIHAR |
9939548239
rishitmani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee ,AIIMSPatna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Radiological Percutaneous Interventions |
Radiological Percutaneous Interventions involves the placement of catheters percutaneous under imaging guidance to drain infected necrotic material in pancreas |
| Intervention |
Video-Assisted Retroperitoneal Debridement |
Video-Assisted Retroperitoneal Debridement is a minimally invasive procedure that provides direct access to the necrotic cavity through a retroperitoneal approach, allowing for thorough debridement under video assistance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of more than 18 years ago with Documented infected necrotizing pancreatitis for more than 14 days of disease onset and Catheter drainage of the collection with infected necrosis is technically feasible as deemed by the Expert Radiologist and/or treating physician |
|
| ExclusionCriteria |
| Details |
Conditions with Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome),or
Previous retroperitoneal intervention for necrotizing pancreatitis or Documented chronic pancreatitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Video assisted retroperitoneal debridement compared to radiological percutaneous interventions in patients with suspected infected pancreatic necrosis. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the proportion of different outcomes among patients undergoing VARD and RPI in terms of Mortality, New onset (multi) organ failure, Bleeding requiring intervention, Perforation requiring intervention, Fistula formation,Incisional hernia, Wound infections, Endocrine and exocrine pancreas insufficiency, Number of patients with severe complications (Clavien-Dindo III or higher), Number of patients per Clavien-Dindo classification, Number of (re-)interventions, hospital and ICU length of stay, Direct costs.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="1" 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
|
Infected pancreatic necrosis is a severe complication of acute pancreatitis, requiring timely and appropriate intervention. While percutaneous catheter drainage has been widely used, it often fails to remove solid necrotic debris completely. Video-assisted retroperitoneal debridement has emerged as a minimally invasive alternative, allowing for direct debridement and better outcomes in selected patients.
Initial management of necrotizing pancreatitis is conservative, with intervention reserved for infected necrosis and clinical deterioration. Open necrosectomy, although effective, carries significant risks, including high mortality, incisional hernia, and fistula formation. Recent guidelines and trials, such as the PANTER study, have favored a step-up approach—starting with PCD and escalating to VARD if needed—due to lower morbidity and equivalent long-term outcomes.
VARD has shown efficacy, especially in deep-seated or complex collections. Studies report overall mortality around 13percent, with complications such as pancreatic fistula, bleeding, enteric fistula, and organ perforation. On average, one to three VARD procedures may be required. Approximately 61 percent of patients can be successfully treated with VARD alone.
Comparative studies, including the POINTER and TENSION trials, indicate that delayed and minimally invasive interventions are generally favorable over early or open approaches. However, VARD’s role is still evolving, and optimal patient selection remains crucial. While endoscopic techniques may offer advantages in some settings, VARD continues to play a key role in cases where PCD alone is inadequate.
This trial aims to assess the safety and efficacy of VARD compared to radiological percutaneous interventions, hypothesizing that VARD offers improved clinical outcomes in appropriate patient populations. |