Billroth II or Roux-en-Y Reconstruction for GJ After PD: Randomized Controlled Trial (PAUDA TRIAL)
NCT ID: NCT02246205
Last Updated: 2017-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2013-02-28
2015-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DPC DN
Roux-en Y reconstruction after pancreaticoduodenectomy
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.
DPC UN
Child reconstruction after pancreaticoduodenectomy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
ALL
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Responsible Party
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JULI BUSQUETS BARENYS
Medicine Doctor
Principal Investigators
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JULI BUSQUETS
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Locations
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Hospital Universitari de Bellvitge
Hospitalet Llobregat, Barcelona, Spain
Countries
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Other Identifiers
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PAUDA
Identifier Type: -
Identifier Source: org_study_id