| CTRI Number |
CTRI/2026/03/105364 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Short term outcomes of minimally invasive versus Open Pancreaticoduodenectomy |
|
Scientific Title of Study
|
Short term outcomes of Robotic/Laparoscopic/Hybrid-robotic-laparoscopic versus Open Pancreaticoduodenectomy:A Prospective Observational Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prathiksha Gavaskar |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Surgery,JIPMER Hospital, JIPMER Campus, Gorimedu, Dhanvantri nagar,Pondicherry
JIPMER Hospital, JIPMER Campus, Gorimedu, Dhanvantri nagar,Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9343722972 |
| Fax |
|
| Email |
prathikshagavaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debasis Naik |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Surgery, JIPMER Hospital, JIPMER Campus, Gorimedu, Dhanvantri nagar,Pondicherry
JIPMER Hospital, JIPMER Campus, Gorimedu, Dhanvantri nagar,Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8763124660 |
| Fax |
|
| Email |
debasismbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debasis Naik |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Surgery, JIPMER Hospital, JIPMER Campus, Gorimedu, Dhanvantri nagar,Pondicherry
JIPMER Hospital, JIPMER Campus, Gorimedu, Dhanvantri nagar,Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8763124660 |
| Fax |
|
| Email |
debasismbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER Hospital, JIPMER campus road, Gorimedu, Dhanvantri Nagar, Pondicherry. 605006 |
| Type of Sponsor |
Government medical college |
|
|
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 Debasis Naik |
JIPMER Hospital |
JIPMER Hospital, jipmer campus road, gorimedu, dhanvantri nagar, Pondicherry.
Pondicherry
PONDICHERRY |
8763124660
debasismbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 90 years undergoing robotic or laparoscopic or hybrid robotic,laparoscopic pancreaticoduodenectomy or open pancreaticoduodenectomy for various benign and malignant conditions of the pancreas or periampullary region |
|
| ExclusionCriteria |
| Details |
Patients requiring another concomitant organ resection.
Patients requiring vascular reconstruction during pancreaticoduodenectomy.
Pregnancy
American Society of Anesthesiologists (ASA) score more than 3.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To compare the CCI following robotic/ laparoscopic/ hybrid-robotic-laparoscopic pancreaticoduodenectomy and open pancreaticoduodenectomy. |
duration of 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare the incidence of grade B/C pancreas-specific complications following robotic/ laparoscopic/ hybrid-robotic-laparoscopic pancreaticoduodenectomy & open pancreaticoduodenectomy.
• To compare the reintervention rates, reoperation & readmission following robotic/ laparoscopic/ hybrid-robotic-laparoscopic pancreaticoduodenectomy & open pancreaticoduodenectomy.
• To compare the 30-day postoperative mortality following robotic/ laparoscopic/ hybrid-robotic-laparoscopic pancreaticoduodenectomy & open pancreaticoduodenectomy.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
15/03/2026 |
| 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 Yet Recruiting |
| 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
|
Minimally invasive surgery appears to be safe and more precise as compared to open surgeries, leading to better outcomes in post-operative period, forming rationale for our study. Hence comparing the comprehensive complication index between robotic/laparoscopic/hybrid robotic-laparoscopic vs open studies will lead to our desired outcome of finding better method with lesser complications for patients undergoing pancreaticoduodenectomies. We will also compare grade B and C pancreas specific complications, re-operation, re-intervention and readmission, and also 30 day mortality of patients in the post-operative period. The patients will be followed up in day 15 and day 30 following surgery. |