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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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