| CTRI Number |
CTRI/2023/10/058478 [Registered on: 10/10/2023] Trial Registered Prospectively |
| Last Modified On: |
06/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of early post-operative outcomes between Laparoscopic-Assisted whipples procedure and Open Whipples procedure - A pilot study |
|
Scientific Title of Study
|
Comparative analysis of early post-operative outcomes between Laparoscopic-Assisted Pancreaticoduodenectomy and Open Whipples pancreaticoduodenectomy - A pilot 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 |
Dr Asuri Krishna |
| Designation |
Additional 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 |
9051742097 |
| Fax |
|
| Email |
dr.asurikrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asuri Krishna |
| Designation |
Additional 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 |
9051742097 |
| Fax |
|
| Email |
dr.asurikrishna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushrut Chandra |
| 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 |
9837504440 |
| Fax |
|
| Email |
drskchandra@rediffmail.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 |
| 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 |
AIIMS New Delhi |
Room no- 406 4th floor
Surgery block AIIMS
New delhi Pin-110049
South West
DELHI
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 ot block 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, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laparoscopic Assisted Pancreaticoduodenectomy |
Laparoscopic ports inserted, after creating
Pneumoperitoneum. We will divide gastrocolic omentum, enter the lesser sac,
identify the right gastroepiploic vessels, then ligate and divide the same. Then
Kocherisation of duodenum will be done. Next step is to identify the Superior
Mesentric vein at inferior border of pancreas and create a tunnel between neck of
pancreas and SMV-PV axis. Hepatoduodenal ligament will be divided to identify
Right Gastric artery and Gastroduodenal artery. We will divide Stomach at
antropyloric junction, Jejunum near to DJ flexure and Pancreas at neck, above the
tunnel
Upper midline incision will be given from xiphisternum till supraumbilical port,
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 Surgeon’s 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
Duration of procedure - 3.5 hours (210 minutes) |
| Intervention |
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 Surgeon’s 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
Duration of procedure - 3 hours (180 minutes) |
|
|
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 |
1 Patients with Non resectable Tumor -
Detected IntraOperatively - Requiring Triple
Bypass
2 Tumor involvement of major vasculature
(SMV,PV,SMA,HA)
3 BMI > 35 kg/m2
4 Patients with ongoing pancreatitis
5 Patients with previous abdominal
surgery/Abdominal scars
6 Converted cases from Laparoscopic/Lapassisted to Open Whipple’s
Pancreaticoduodenectomy
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Morbidity - Bleeding,Abdominal pain on visual analogue scale(VAS), Pancreatic fistula, Quality of life score – As per EuroQOL |
Perioperative, VAS at 24 hrs, 4 weeks and 3 months, Quality of life at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mortality rates |
within 30-day PostOperative |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/10/2023 |
| 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
|
Laparoscopic/Minimal Invasive surgeries have suggested to enhance postOperative 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 pilot study is to conduct a preliminary
comparative analysis of postoperative complications and mortality between
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. Limited literature described the safety and efficacy of LAPD. Meanwhile,
comparative study lacked for LAPD and OPD.
The purpose of the present study
is to compare the postoperative outcomes of LAPD and OPD - Postoperative
complications. |