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临床试验/CTRI/2025/11/097887
CTRI/2025/11/097887
尚未招募
2/3 期

Early post operative outcomes and PROM following Robotic-Assisted Pancreaticodiodenectomy RAW Laparoscopic-Assisted Pancreaticoduodenectomy LAW and Open Whipples Pancreaticoduodenectomy OWL a three arm RCT

Dr Asuri Krishna1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年11月28日最近更新:

概览

阶段
2/3 期
状态
尚未招募
发起方
Dr Asuri Krishna
入组人数
75
试验地点
1
主要终点
Morbidity as per Clavein-Dindo Classification

概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Morbidity as per Clavein-Dindo Classification

时间窗: At the time of discharge, 1 month and 3 months

次要结局

  • Operative time(Intraoperative)
  • Duration of hospital stay(At discharge)
  • Mortality(At discharge, 1 month and 3 months)
  • Wound infection rate(At discharge, 1 month and 3 months)
  • 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)

研究者

发起方
Dr Asuri Krishna
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Dr Asuri Krishna

All india institute of medical sciences, New delhi

研究点 (1)

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