Malignant Neoplasm of Head of Pancreas Clinical Trial
Official title:
Billroth II or Roux-en-Y Reconstruction for Gastrojejunostomy After Pancreaticoduodenectomy: Randomized Controlled Trial (PAUDA TRIAL): Comparison of Morbidity and Delayed Gastric Emptying
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.
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.
;