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CTRI Number  CTRI/2024/05/067014 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 07/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomised study to study the impact of reinforcement patch on pancreatic fistula after Pancreatoduodenectomy 
Scientific Title of Study   Outcomes of Reinforcement Patch Around Pancreaticojejunostomy on Clinically Relevant Pancreatic Fistula After Pancreatoduodenectomy- A Randomised Controlled Trial 
Trial Acronym  OTP Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaikh Muna Afroz Moizuddin 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Surgical Gastroenterology, All India Institute of Medical Sciences Basni Industrial Area, Phase 2, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7709459554  
Fax    
Email  drmunafroz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vaibhav Kumar Varshney 
Designation  Additional Professor and Head of Department 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Surgical Gastroenterology, All India Institute of Medical Sciences, Basni Industrial Area, Phase 2, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9968223072  
Fax    
Email  drvarshney09@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vaibhav Kumar Varshney 
Designation  Additional Professor and Head of Department 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Surgical Gastroenterology, All India Institute of Medical Sciences, Basni Industrial Area, Phase 2, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9968223072  
Fax    
Email  drvarshney09@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Shaikh Muna Afroz Moizuddin 
Address  Department of Surgical Gastroenterology, All India Institute of Medical Sciences, Basni Industrial Area, Phase-II, Jodhpur-342005 
Type of Sponsor  Other [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 
Shaikh Muna Afroz Moizuddin  AIIMS, Jodhpur  Department of Surgical Gastroenterology, 5th Floor, C block, Room No.-549 AIIMS, Basni Industrial Area, Phase-II, Jodhpur Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 7709459554

drmunafroz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institue of Medical Sciences, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C241||Malignant neoplasm of ampulla of Vater, (2) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas, (3) ICD-10 Condition: C240||Malignant neoplasm of extrahepaticbile duct, (4) ICD-10 Condition: K831||Obstruction of bile duct, (5) ICD-10 Condition: C253||Malignant neoplasm of pancreatic duct,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Application of Verisetâ„¢ patch around pancreaticojejunostomy   Firstly, the resection part of Pancreatoduodenectomy will be performed as per the inclusion criteria. Following this, a standard duct-to-mucosa pancreaticojejunostomy will be done. After that, in the intervention arm, after the randomisation, a Verisetâ„¢ patch will be placed around (anterior and posterior) the anastomosis. In the postoperative period, the incidence of clinically relevant pancreatic fistula will be analyzed and compared with the comparator group.  
Comparator Agent  Standard duct-to-mucosa pancreaticojejunostomy   Firstly, the resection part of Pancreatoduodenectomy will be performed as per the inclusion and exclusion criteria. Following this, a standard duct-to-mucosa pancreaticojejunostomy will be done. After that, in the comparator, after the randomisation, nothing will be placed around (anterior and posterior) the anastomosis. In the postoperative period, the incidence of clinically relevant pancreatic fistula will be analyzed and compared with the intervention group.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients undergoing Pancreatoduodenectomy with duct-to-mucosa Pancreaticojejunostomy
2. Benign or Malignant etiologies
3. ≥18 years of age 
 
ExclusionCriteria 
Details  1. Subjected to multivisceral resection along with Pancreatoduodenectomy
2. Dunking type of pancreaticojejunostomy or Pancreaticogastrostomy
3. Patients who received neoadjuvant therapy
4. Immunosuppressed patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Development of Clinically Relevant Post Operative Pancreatic Fistula (type B and C) as per the ISGPS definition  Perioperative period 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of intensive care unit (ICU) stay.
2) Duration of post-operative hospital stay.
3) Reintervention
4) 30-day morbidity
a) Deep/organ space infection
b) Delayed gastric emptying.
c) Post-pancreatomy hemorrhage.
d) Other complications
5) Death (irrespective of the cause). 		 Perioperative Period 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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 1 
Date of First Enrollment (India)   19/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drvarshney09@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Although different surgical approaches are currently used for pancreatoduodenectomy (PD), there does not seem to be an optimal technique that significantly decreases Post-operative Pancreatic Fistula (POPF) rates. Despite post-operative mortality rates having significantly decreased to less than 5 %, PD may still be associataed with relevant morbidity, mainly related to POPF. Various studies have evaluated the role of application of sealant patches in prevention of POPF after pancreaticojejunostomy. However no study till date has evalluated the efficacy of reinforcement patches [ Combination of Oxidised regenerataed cellulose, Trilysine and Polyethylene Glycol (OTP)] in preventing CR-POPF (Clinically-Relevant Post-Operative Pancreatic Fistula) after pancreatoduodenectomy in the Indian scenario. This study will be the first of its kind. 
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