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

Study Overview

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

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.

Malignant Neoplasm of Head of Pancreas

PROCEDURE: Pancreaticoduodenectomy

PAUDA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-09-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-10-13
First Submitted that Met QC Criteria 2014-09-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-10-16
First Posted (ACTUAL) 2014-09-22	Results First Posted N/A	Last Verified 2017-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: DPC DN Roux-en Y reconstruction after pancreaticoduodenectomy	PROCEDURE: Pancreaticoduodenectomy Pancreaticoduodenectomy is the classical operative technique to resect cephalic pancreatic cancer. In a first phase of the surgery, the resection may be performed. In the second phase, the digestive tract must be restored. We planify two different reconst
ACTIVE_COMPARATOR: DPC UN Child reconstruction after pancreaticoduodenectomy	PROCEDURE: Pancreaticoduodenectomy Pancreaticoduodenectomy is the classical operative technique to resect cephalic pancreatic cancer. In a first phase of the surgery, the resection may be performed. In the second phase, the digestive tract must be restored. We planify two different reconst

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: DPC DN

Roux-en Y reconstruction after pancreaticoduodenectomy

PROCEDURE: Pancreaticoduodenectomy

Pancreaticoduodenectomy is the classical operative technique to resect cephalic pancreatic cancer. In a first phase of the surgery, the resection may be performed. In the second phase, the digestive tract must be restored. We planify two different reconst

ACTIVE_COMPARATOR: DPC UN

Child reconstruction after pancreaticoduodenectomy

PROCEDURE: Pancreaticoduodenectomy

Pancreaticoduodenectomy is the classical operative technique to resect cephalic pancreatic cancer. In a first phase of the surgery, the resection may be performed. In the second phase, the digestive tract must be restored. We planify two different reconst

Primary Outcome Measures	Measure Description	Time Frame
Delayed gastric emptying incidence after pancreaticoduodenectomy	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	within the first 60 daysafter surgery

Secondary Outcome Measures	Measure Description	Time Frame
Morbidity and complications after pancreaticoduodenectomy	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.	within the first 60 daysafter surgery

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: JULI BUSQUETS, Hospital Universitari de Bellvitge

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

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Clinical Trial Record