Comparison of early post-operative outcomes between Laparoscopic-Assisted whipples procedure and Open Whipples procedure - A pilot study

Phase 2/3

Not yet recruiting

• Conditions: Malignant neoplasm of head of pancreas, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2023/10/058478
• Lead Sponsor: Dr Asuri Krishna

Brief Summary

Laparoscopic/Minimal Invasive surgeries have suggested to enhance postOperative recovery when compared to their Open counterparts, However, there areconcerns about the extensive learning curve due to the complex nature whichcould increase the risk of complications.

Pancreatoduodenectomy is the only curative treatment option forperiampullary 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 preliminarycomparative analysis of postoperative complications and mortality betweenlaparoscopic-assisted Whipple’s procedure and open Whipple’spancreaticoduodenectomy. By exploring a smaller dataset of patients who willundergo either technique, we aim to provide initial insights into potential differencesin outcomes.



The cost-effectiveness and quality of life associated with MIPD havecurrently only been reported in small observational studies. These studiesreported higher operative costs of MIPD, which were compensated by lowerpostoperative costs because of shorter hospital stay. However, the limitedsample sizes of these studies do not allow reliable conclusions. Outcomes of open pancreatoduodenectomy have also improved in recent yearswith enhanced recovery strategies leading to shorter postoperative hospital stay. These parameters should therefore be assessed in a multicenter randomizedtrial using an enhanced recovery setting for both MIPD and openpancreatoduodenectomy.



Laparoscopic assisted pancreaticoduodenectomy (LAPD), a hybridprocedure combining laparoscopic resection and reconstruction under a smallincision, may serve as an alternative on the road to matured application of TLPD.The potential advantages of LAPD include more precise mobilization anddissection compared with OPD, and more precise reconstruction and hemostasiscompared with TLPD, which will possibly lead to a more favorable postoperativerecovery. Limited literature described the safety and efficacy of LAPD. Meanwhile,comparative study lacked for LAPD and OPD.



The purpose of the present studyis to compare the postoperative outcomes of LAPD and OPD - Postoperativecomplications.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-10
• Study Start: 2023-10-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients (age 18 years or older). Surgical Obstructive Jaundice with diagnosed proven PeriAmpullary mass.
• requiring Pancreaticoduodenectomy Benign, premalignant/malignant Pancreatic diseases requiring Pancreaticoduodenectomy.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
mortality rates	within 30-day PostOperative

Trial Locations

Locations (1)

AIIMS New Delhi; 🇮🇳 Delhi, DELHI, India

AIIMS New Delhi

🇮🇳Delhi, DELHI, India

Dr Asuri Krishna

Principal investigator

9999405767

dr.asurikrishna@gmail.com