Billroth II or Roux-en-Y Reconstruction for GJ After PD: Randomized Controlled Trial (PAUDA TRIAL)

Catalan Institute of Health

Status

Completed

Conditions

Malignant Neoplasm of Head of Pancreas

Treatments

Procedure: Pancreaticoduodenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02246205

PAUDA

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.