Comparative analysis of early post-operative outcomes between Laparoscopic-Assisted Pancreaticoduodenectomy and Open Whipples pancreaticoduodenectomy - A pilot study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Morbidity - Bleeding,Abdominal pain on visual analogue scale(VAS), Pancreatic fistula, Quality of life score – As per EuroQOL
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
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
- •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.
结局指标
主要结局
Morbidity - Bleeding,Abdominal pain on visual analogue scale(VAS), Pancreatic fistula, Quality of life score – As per EuroQOL
时间窗: Perioperative, VAS at 24 hrs, 4 weeks and 3 months, Quality of life at 3 months
次要结局
- mortality rates(within 30-day PostOperative)