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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  
AIIMS, New Delhi 
 
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  
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 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  
Status 
Not Applicable 
 
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.
 

 
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