Isolated Pancreatic Loop With Modified Pancreaticojejunos... | NCT04843670

Studies
Isolated Pancreatic Loop With Modified Pancreaticojejunostomy

NCT04843670

Sponsor

Université de Sousse

Status

Completed

Last Update Posted

Apr 13, 2021Actual

Enrollment

201Actual

Phase

Not provided

Conditions

Pancreaticoduodenectomy

Interventions

duodenopancreatectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Apr 7, 2021

First Submission Date that Met QC Criteria

Apr 11, 2021

First Posted Date

Apr 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2021

Last Update Posted Date

Apr 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Postoperative pancreatic fistula (POPF) is widely regarded as the most threatening complication following pancreaticoduodenectomy (PD). Its clinical impact and sequelae have been previously described and shown to contribute to the development of other morbid complications and high rates of mortality.

Methods: We report our early experience using a modified PJ technique with an isolated pancreatic loop after after PD in 201 patients between January 2010 and December 2020.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

201Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients operated for pancreas tumors		duodenopancreatectomy for head of the pancreas tumors	Procedure: duodenopancreatectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
duodenopancreatectomy	Procedure	resection of the head of the pancreas, the mower part of the biliary duct, and antrectomy	patients operated for pancreas tumors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of pancreatic fistula	level of lipase in abdominal drain after suregry	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age up to 30
head of the pancreas tumor

Exclusion Criteria:

body and tail pancreatic tumors

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

all patients undergoing duodenopancreatectomy procedure, in the surgery department .

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
ali ben ali, PROFESSOR	university of sousse	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016577	Pancreaticoduodenectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

Not provided