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

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ClinicalTrials.gov Identifier: NCT02246205
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
JULI BUSQUETS BARENYS, Hospital Universitari de Bellvitge

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Head of Pancreas Procedure: Pancreaticoduodenectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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 reconstruction techniques.

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 reconstruction techniques.




Primary Outcome Measures :
  1. Delayed gastric emptying incidence after pancreaticoduodenectomy [ Time Frame: within the first 60 daysafter surgery ]
    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


Secondary Outcome Measures :
  1. Morbidity and complications after pancreaticoduodenectomy [ Time Frame: within the first 60 daysafter surgery ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246205


Locations
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Spain
Hospital Universitari de Bellvitge
Hospitalet Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
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Principal Investigator: JULI BUSQUETS Hospital Universitari de Bellvitge

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Responsible Party: JULI BUSQUETS BARENYS, Medicine Doctor, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT02246205     History of Changes
Other Study ID Numbers: PAUDA
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017
Keywords provided by JULI BUSQUETS BARENYS, Hospital Universitari de Bellvitge:
pancreaticoduodenectomy
delayed gastric emptying
Roux en-Y reconstruction
Additional relevant MeSH terms:
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Neoplasms