| CTRI Number |
CTRI/2025/12/098288 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized trial to compare the complications and oncological outcomes between two techniques of robotic and laparoscopic pancreatoduodenectomy done for periampullary cancer |
|
Scientific Title of Study
|
Peri-operative and Oncological Outcomes of Robotic Vs Laparoscopic Pancreatoduodenectomy: A Randomised Controlled Trial |
| Trial Acronym |
ROBOLA Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Kumar Varshney |
| Designation |
Additional Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Surgical Gastroenterology
5th Floor, C block, Room No. 549
Basni Industrial Area, Phase-II
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9968223072 |
| Fax |
|
| Email |
drvarshney09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaibhav Kumar Varshney |
| Designation |
Additional Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Surgical Gastroenterology
5th Floor, C block, Room No. 549
Basni Industrial Area, Phase-II
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 |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Surgical Gastroenterology
5th Floor, C block, Room No. 549
Basni Industrial Area, Phase-II
RAJASTHAN
342005
India |
| Phone |
9968223072 |
| Fax |
|
| Email |
drvarshney09@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vaibhav Kumar Varshney |
| Address |
Department of Surgical Gastroenterology, All India Institute of
Medical Sciences, Basni Industrial Area, Phase-II, 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 Vaibhav Kumar Varshney |
AIIMS, Jodhpur |
Room No. 549, C block, 5th floor,
Department of Surgical Gastroenterology
Jodhpur
RAJASTHAN |
919968223072
drvarshney09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical Trial) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C241||Malignant neoplasm of ampulla of Vater, (2) ICD-10 Condition: C240||Malignant neoplasm of extrahepaticbile duct, (3) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laparoscopic Pancreatoduodenectomy |
Analysis of perioperative and oncological outcomes of Laparoscopic Pancreatoduodenectomy and comparing it with Robotic Pancreatoduodenectomy.
Total Duration: Each surgical procedure lasts 6 to 8 hours. The total study duration will be 2 years and 6 months. |
| Intervention |
Robotic Pancreatoduodenectomy |
Analysis of perioperative and oncological outcomes of Robotic Pancreatoduodenectomy and comparing it with Laparoscopic
Pancreatoduodenectomy.
Total Duration: Each surgical procedure lasts 6 to 8 hours. The total study duration will be 2 years and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a) Age above 18 years
b) Patients undergoing minimally invasive PD for clinically indicated malignant or premalignant lesions in the pancreatic and periampullary region
c) Resectable lesion less than 4 cm in size without vascular invasion
d) ECOG performance status 0 or 1
e) Absence of prohibitive cardiopulmonary comorbidities that preclude prolonged pneumoperitoneum
f) Absence of uncorrected coagulopathy, chronic liver disease, or chronic renal disease
|
|
| ExclusionCriteria |
| Details |
a) Pregnancy
b) Previous history of major upper abdominal surgery
c) Open or Hybrid Pancreatoduodenectomy
d) Emergency Pancreatoduodenectomy
e) Requirement for multi-visceral resection
f) Borderline or locally advanced Pancreatic cancer
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Major Surgical Complications at 30 days (Clavien Dindo Grade more than or equal to IIIa) |
Outcome will be assessed at the time of discharge after Pancreatoduodenectomy and at 90-day follow-up.
Additionally, if there are any readmissions within the first 90 days after surgical intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Intraoperative: Operative duration, intraoperative blood loss, need for transfusion, conversion rate to open
b. Postoperative: Delayed gastric emptying (DGE), postoperative pancreatic fistula (POPF), post pancreatectomy hemorrhage (PPH) as per ISGPS criteria (references), bile leak, surgical site infection, length of postoperative hospital stay, 30-day mortality, readmission, & resurgery rates
c. Histopathological: Number of lymph nodes harvested, R0 resection rate
|
Outcome will be assessed at the time of discharge after Pancreatoduodenectomy & at 90-day follow-up.
Additionally, if there are any readmissions within the first 90 days after surgical intervention. |
|
|
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)
|
15/12/2025 |
| 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="6"
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
|
Pancreatoduodenectomy (PD) is the standard surgical treatment for malignant and benign diseases of the pancreatic head, duodenum, ampulla of Vater, and distal common bile duct. Minimally invasive approaches, such as Laparoscopic PD (LPD) and Robotic PD (RPD), are increasingly performed, but there is limited high-quality evidence directly comparing their safety and oncological efficacy.
This prospective study aims to compare perioperative outcomes and short-term oncological results between LPD and RPD. The primary objective is to assess whether RPD reduces major postoperative morbidity (Clavien–Dindo grade more than or equal to IIIa) compared to LPD. Secondary objectives include evaluation of operative parameters, postoperative recovery, complication profile, margin status, lymph-node yield, and 90 day mortality. Findings from this trial will help define the optimal minimally invasive approach for PD.
|