Clinical trial NCT02246205: Billroth II or Roux-en-Y Reconstruction for GJ After PD: Randomized Controlled Trial (PAUDA 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm of Head of Pancreas
Keywords: pancreaticoduodenectomy
delayed gastric emptying
Roux en-Y reconstruction
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Delayed gastric emptying incidence after pancreaticoduodenectomy
timeFrame: within the first 60 daysafter surgery
Secondary outcomes:
measure: Morbidity and complications after pancreaticoduodenectomy
timeFrame: within the first 60 daysafter surgery
Other outcomes:
Locations:
city: Hospitalet Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: JULI BUSQUETS
role: PRINCIPAL_INVESTIGATOR
References: