| CTRI Number |
CTRI/2025/02/080071 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| 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 Pancreaticodudoenectomy done using ePTFE on pancreatic fistula |
|
Scientific Title of Study
|
Impact of ePTFE Suture for Pancreaticojejunosotmy on Clinically Relevant Post-operative Pancreatic Fistula after Pancreatoduodenectomy: A 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 |
Pavithran T |
| 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 |
9944280086 |
| Fax |
|
| Email |
pavithrant11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peeyush Varshney |
| Designation |
Associate Professor |
| 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 |
9929069007 |
| Fax |
|
| Email |
drpeeyushvarshney@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peeyush Varshney |
| Designation |
Associate Professor |
| 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 |
9929069007 |
| Fax |
|
| Email |
drpeeyushvarshney@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences , Jodhpur |
|
|
Primary Sponsor
|
| Name |
Pavithran T |
| Address |
Department of Surgical Gastroenterology, All India Institute of
Medical Sciences, Basni Industrial Area, Phase 2, Jodhpur |
| 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 |
| Dr Pavithran T |
All India Institute Of Medical Sciences, Jodhpur |
Department of Surgical
Gastroenterology, 5th
Floor, C block, Room
No.-549 AIIMS, Basni
Industrial Area,
Phase-II, Jodhpur
Jodhpur
RAJASTHAN |
9944280086
pavithrant11@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: D132||Benign neoplasm of duodenum, (2) ICD-10 Condition: D136||Benign neoplasm of pancreas, (3) ICD-10 Condition: C240||Malignant neoplasm of extrahepaticbile duct, (4) ICD-10 Condition: C241||Malignant neoplasm of ampulla of Vater, (5) ICD-10 Condition: C253||Malignant neoplasm of pancreatic duct, (6) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard duct-to-mucosa
pancreaticojejunostomy |
Firstly, the resection part of Pancreatoduodenectomy will be performed as per the inclusion criteria. Following this, a duct-to-mucosa pancreaticojejunostomy will be done using PDS suture in the comparator arm. In the postoperative period, the incidence of clinically relevant pancreatic fistula will be analyzed and compared with the intervention group. |
| Intervention |
Use of ePTFE for Pancreaticojejunostomy |
Firstly, the resection part of Pancreatoduodenectomy
will be performed as per the inclusion criteria.
Following this, a duct-to-mucosa
pancreaticojejunostomy will be done using ePTFE suture in the intervention arm. In the postoperative period, the incidence
of clinically relevant pancreatic fistula will be analyzed
and compared with the comparator 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. More than or equal to 18 years of age |
|
| ExclusionCriteria |
| Details |
1. Dunking type of pancreaticojejunostomy
2. Pancreaticogastrostomy
|
|
|
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 |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of stay in the intensive care unit (ICU).
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. 90 day Mortality
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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="2"
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
|
Although different surgical
approaches are currently used for PD (Pancreatoduodenectomy), there does not
seem to be an optimal technique that significantly decreases POPF rates [1].
Despite postoperative mortality rates having significantly decreased to less
than 5%, PD may still be associated with relevant morbidity, mainly related to
POPF (Post-Operative Panceatic Fistula) (2,3). Various studies have evaluated the role of application of sealant
patches in prevention of POPF after pancreaticoojejunostomy . However only few studies study till date has evaluated the efficacy of e PTFE sutures in
preventing CR-POPF (Clinically-Relevant
Post-Operative Panceatic Fistula) after pancreatoduodenectomy in the Indian scenario |