NCT02246205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

September 16, 2014

Last Update Submit

October 13, 2017

Conditions

Malignant Neoplasm of Head of Pancreas

Keywords

pancreaticoduodenectomydelayed gastric emptyingRoux en-Y reconstruction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Morbidity and complications after pancreaticoduodenectomy

    within the first 60 daysafter surgery

Study Arms (2)

DPC DN

EXPERIMENTAL

Roux-en Y reconstruction after pancreaticoduodenectomy

Procedure: Pancreaticoduodenectomy

DPC UN

ACTIVE COMPARATOR

Child reconstruction after pancreaticoduodenectomy

Procedure: Pancreaticoduodenectomy

Interventions

PancreaticoduodenectomyPROCEDURE

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 DNDPC UN

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

Hospitalet Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • JULI BUSQUETS

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medicine Doctor

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 22, 2014

Study Start

February 1, 2013

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

ES(1)