| CTRI Number |
CTRI/2025/11/097887 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Robotic, Laparoscopic, and Open Surgery for Periampullary Tumors: Early Outcomes and Patient Experience - A clinical trial |
|
Scientific Title of Study
|
Early post operative outcomes and PROM following Robotic-Assisted Pancreaticodiodenectomy RAW Laparoscopic-Assisted Pancreaticoduodenectomy LAW and Open Whipples Pancreaticoduodenectomy OWL a three arm RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asuri Krishna |
| Designation |
Professor |
| Affiliation |
All india institute of medical sciences, New delhi |
| Address |
Room no-406 4th Floor Surgery Block Aiims New Delhi Pin-110049 South West DELHI 110049 India
New Delhi DELHI 110046 India |
| Phone |
9999405767 |
| Fax |
|
| Email |
dr.asurikrishna@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Asuri Krishna |
| Designation |
Professor |
| Affiliation |
All india institute of medical sciences, New delhi |
| Address |
Room no-406 4th Floor Surgery Block Aiims New Delhi Pin-110049 South West DELHI 110049 India
DELHI 110046 India |
| Phone |
9999405767 |
| Fax |
|
| Email |
dr.asurikrishna@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vedant Kashikar |
| Designation |
MS General Surgery |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no-406 4th Floor Surgery Block Aiims New Delhi Pin-110049 South West DELHI 110049 India
New Delhi DELHI 110049 India |
| Phone |
9136593104 |
| Fax |
|
| Email |
kashikarvedant26@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Asuri Krishna |
| Address |
Room no-406 4th Floor Surgery Block Aiims New Delhi Pin-110049 South West DELHI 110049 India |
| 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 Asuri Krishna |
All india institute of medical sciences, New delhi |
Room no-406 4th Floor Surgery Block New Delhi DELHI |
9999405767
dr.asurikrishna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee AIIMS Room No 710,711, 7th floor NCA building, Ansari Nagar New Delhi 29 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic assisted Pancreaticoduodenectomy |
Laparoscopic ports inserted, after creating Pneumoperitoneum. Dissection will be done using laparoscopy
An 8cm incision will be given for specimen retrieval and anastamosis
|
| Comparator Agent |
Open Pancreaticoduodenectomy |
Roof top incision will be given, incise sheath, muscle and peritoneum layer and enter the peritoneal cavity. Hepatic flexure of the colon will be mobilized, Duodenum kocherized and SMV, SMA, and PV identified, will dissect Porta to identify the common hepatic artery. Hepatoduodenal ligament will be divided to identify Right Gastric artery and Gastroduodenal artery. Tunnel created between head of pancreas and SMV-PV axis. We will divide Stomach at antropyloric junction, Jejunum near to DJ flexure and Pancreas at neck, above the tunnel. We will divide CBD below level of cystic duct insertion, delivering the Pancreaticoduodenectomy and cholecystectomy specimen Now for the anastomosis part, Pancreaticojejunostomy and dunking pancreaticogastrostomy can be done as per Surgeons preference We will create Isolated loop by dividing the jejunum distally and subsequently End to side, duct to mucosa Hepaticojejunostomy done (Posterior continuous followed by anterior interrupted), End to side gastro-jejunostomy (or Loop Gastrojejunostomy), Side to side iso-peristaltic jejuno-jejunostomy and feeding Jejunostomy will be done completing the procedure |
| Intervention |
Robotic Assisted Pancreaticoduodenectomy |
Under General Anaesthesia, Parts will be painted and draped
Robotic Ports will be placed as follows:
R1 - 8MM - Fenestrated bipolar forceps
R2 - 12MM - Endoscope
R3 - 8MM - Vessel sealer
R4 - 8MM - Cadiere
A1 - 12MM - Air seal port
A2 - 5MM - Lap retraction
Robotic arms will be docked
Dissection will be done using robot
An 8cm midline incision above the umbilicus will be given for specimen retrieval and anastomosis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (age 18 years or older).
Surgical Obstructive Jaundice with
diagnosed proven PeriAmpullary mass -
requiring Pancreaticoduodenectomy
Benign, premalignant/malignant Pancreatic
diseases requiring
Pancreaticoduodenectomy |
|
| ExclusionCriteria |
| Details |
metastatic disease
Presence of unresectable tumor detected pre-operative or intra-operatively
BMI more than 35 kg/m2
Patients with ongoing pancreatitis
Patients with previous abdominal surgery
Patients with absolute contraindications of laparoscopic surgeries
Pregnancy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Morbidity as per Clavein-Dindo Classification |
At the time of discharge, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality |
At discharge, 1 month and 3 months |
| Wound infection rate |
At discharge, 1 month and 3 months |
| Operative time |
Intraoperative |
| Duration of hospital stay |
At discharge |
| Rates of clinically relevant - postoperative pancreatic fistula |
post operative day 3, day 5 and At discharge |
| Conversion rate from Robotic assisted Pancreatico-duodenectomy to Open Pancreatico-duodenectomy |
Intraoperative |
| Conversion rate from laparoscopic assisted Pancreatico-duodenectomy to open Pancreatico-duodenectomy |
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
28/11/2025 |
| 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
|
| Minimal Invasive surgeries have suggested to enhance post Operative recovery when compared to their Open counterparts, However, there are concerns about the extensive learning curve due to the complex nature which could increase the risk of complications.
Pancreatoduodenectomy is the only curative treatment option for periampullary cancer, for many benign and premalignant tumors of the region . Pancreaticoduodenectomy was described by Alessandro Codivilla, an Italian surgeon, in 1898.
The primary objective of this Randomized trial study is to conduct a preliminary comparative analysis of postoperative complications and mortality between robotic-assisted whipple’s procedure, laparoscopic-assisted Whipple’s procedure and open Whipple’s pancreaticoduodenectomy. By exploring a smaller dataset of patients who will undergo either technique, we aim to provide initial insights into potential differences in outcomes.
The cost-effectiveness and quality of life associated with MIPD have currently only been reported in small observational studies. These studies reported higher operative costs of MIPD, which were compensated by lower postoperative costs because of shorter hospital stay. However, the limited sample sizes of these studies do not allow reliable conclusions. Outcomes of open pancreatoduodenectomy have also improved in recent years with enhanced recovery strategies leading to shorter postoperative hospital stay. These parameters should therefore be assessed in a multicenter randomized trial using an enhanced recovery setting for both MIPD and open pancreatoduodenectomy.
Laparoscopic assisted pancreaticoduodenectomy (LAPD), a hybrid procedure combining laparoscopic resection and reconstruction under a small incision, may serve as an alternative on the road to matured application of TLPD. The potential advantages of LAPD include more precise mobilization and dissection compared with OPD, and more precise reconstruction and hemostasis compared with TLPD, which will possibly lead to a more favorable postoperative recovery. Almost a decade after laparoscopic Pancreaticoduodenectomy was practised, the development of innovative robotic platforms has
later opened a new horizon for surgical treatment of pancreatic cancer. Robotic
surgery has emerged as a potential alternative to laparoscopy, overcoming some of
the intrinsic limitations of laparoscopy. In the hands of experienced surgeons, RAPD
may have a modest yet statistically significant reduction in estimated blood loss,
postoperative length of stay, wound complications, and delayed gastric emptying
comparing to OPD in similar patients. The purpose of the present study is to compare the postoperative outcomes of RAPD, LAPD and OPD - Postoperative complications.
| |