RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE MORBIDITY ON RECONSTRUCTION AFTER PANCREATICODUODENECTOMY(PAUDA)
Conditions
Malignant Neoplasm of Head of Pancreas
Conditions: official terms
Head and Neck Neoplasms - Neoplasms - Pancreatic Neoplasms
Conditions: Keywords
pancreaticoduodenectomy, delayed gastric emptying, Roux en-Y reconstruction
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pancreaticoduodenectomy
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- Patients with pancreatic head cancer considered resectable after the extension study

- Patients suffering from tumors considered resectable periampullary 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 undergoing previous gastrectomy

- Patients with refusal to initiate the study.

- Patients with unresectable cancer with criteria for inoperability as the presence of metastasis, invasion artery (superior mesenteric artery, celiac axis or hepatic artery), venous obliteration, or invasion of other organs by contiguity (except duodenum.
Location
Hospital Universitari de Bellvitge
Hospitalet Llobregat, Barcelona, Spain
Status: Recruiting
Contact: SILVIA MARTIN - 636830993 - silviamartin1985@gmail.com
Start Date
February 2013
Completion Date
September 2015
Sponsors
Hospital Universitari de Bellvitge
Source
Hospital Universitari de Bellvitge
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page