Billroth II or Roux-en-Y Reconstruction for GJ After PD: Randomized Controlled Trial (PAUDA TRIAL)
- Conditions
- Malignant Neoplasm of Head of Pancreas
- Interventions
- Procedure: Pancreaticoduodenectomy
- Registration Number
- NCT02246205
- Lead Sponsor
- Hospital Universitari de Bellvitge
- Brief Summary
The aim of the study is to compare the effect of Roux-en Y reconstruction (study group, DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after pancreaticoduodenectomy.
- Detailed Description
The pancreaticoduodenectomy (DPC) is the procedure of choice of the tumors of the head of the pancreas, periampullary tumors and intractable inflammatory pathology.
The high postoperative morbidity (50%) involve a mean hospital stay of 15 days after surgery. The most common complication is delayed gastric emptying (DGE), defined as the intolerance to solid oral intake by 7th day postoperative. In some severe cases, oral intolerance can occur after the 21th postoperative day. Therefore, the patient requires parenteral nutrition and prolonged hospital stay.
The aim of the study is to compare the effect of Roux-en Y reconstruction (study group, DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for DPC.
The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after pancreaticoduodenectomy.
A pilot randomized clinical trial has been designed to compare two surgical techniques for reconstruction of digestive tract after DPC in patients treated in our center. The patients are randomized after tumor resection and before the reconstruction througt computer-generated random numbers using a sealed envelope technique. The primary endpoint is the incidence of DGE. Secondary endpoints are postoperative morbidity and specific complications as pancreatic fistula, the hospital stay, and postoperative endocrine and exocrine function.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Patients with pancreatic head cancer considered resectable after the extension study
- Patients suffering from periampullary tumors considered resectable after the extension study
- Patients suffering from pancreatic inflammatory disease with medically intractable pain
- Patients who have read the information sheet of the study and signed the informed consent form
- Patients with history of previous gastrectomy
- Patients with associated resections of other organs, except for the superior portal vein or mesenteric vein
- Patients with enlargement to total pancreatectomy
- Patients who has recieved neoadjuvant treatment
- Patients with plastic peritonitis
- Patients with liver cirrhosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DPC DN Pancreaticoduodenectomy Roux-en Y reconstruction after pancreaticoduodenectomy DPC UN Pancreaticoduodenectomy Child reconstruction after pancreaticoduodenectomy
- Primary Outcome Measures
Name Time Method Delayed gastric emptying incidence after pancreaticoduodenectomy within the first 60 daysafter surgery DGE, defined as oral diet intolerance from the 7th postoperative day, and the persistence of nasogastric tube on the 4th postoperative day or later, according to the ISGPS criteria
- Secondary Outcome Measures
Name Time Method Morbidity and complications after pancreaticoduodenectomy within the first 60 daysafter surgery Postoperative morbidity was defined as any complication that appeared during hospital admission. Postoperative complications and postoperative mortality were defined according to the Clavien-Dindo classification.
Trial Locations
- Locations (1)
Hospital Universitari de Bellvitge
🇪🇸Hospitalet Llobregat, Barcelona, Spain