NCT04843670

Brief Summary

The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD

Trial Health

100
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

11 years

First QC Date

April 7, 2021

Last Update Submit

April 11, 2021

Conditions

Pancreaticoduodenectomy

Keywords

PancreaticoduodenectomypancreaticojejunostomyPostoperative pancreatic fistula.

Outcome Measures

Primary Outcomes (1)

  • incidence of pancreatic fistula

    level of lipase in abdominal drain after suregry

    10 years

Study Arms (1)

patients operated for pancreas tumors

duodenopancreatectomy for head of the pancreas tumors

Procedure: duodenopancreatectomy

Interventions

duodenopancreatectomyPROCEDURE

resection of the head of the pancreas, the mower part of the biliary duct, and antrectomy

patients operated for pancreas tumors

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients undergoing duodenopancreatectomy procedure, in the surgery department .

You may qualify if:

  • age up to 30
  • head of the pancreas tumor

You may not qualify if:

  • body and tail pancreatic tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • ali ben ali, PROFESSOR

    university of sousse

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 13, 2021

Study Start

January 1, 2010

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 13, 2021

Record last verified: 2021-04