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

Malignant Neoplasm of Head of Pancreas Clinical Trial

— PAUDA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246205
• Other study ID #: PAUDA
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: October 13, 2017
• Start date: February 2013
• Est. completion date: April 2015

Study information

• Verified date: October 2017
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis
• Head and Neck Neoplasms
• Malignant Neoplasm of Head of Pancreas
• Neoplasms
• Pancreatic Neoplasms

Intervention

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 reconstruction techniques.

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	Hospitalet Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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