NCT04742166

Brief Summary

Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

February 4, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

February 4, 2021

Last Update Submit

July 27, 2023

Conditions

Surgical Technique

Outcome Measures

Primary Outcomes (1)

  • Post-operative delayed gastric emptying

    Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS))

    Day 90

Secondary Outcomes (13)

  • Occurrence of Clavien-Dindo complications

    Up to day 90

  • Pancreatic fistula

    Up to day 90

  • Biliary fistula

    Up to day 90

  • Haemorrhage

    Up to day 90

  • Food intake (liquid and solid)

    Up to five days after surgery

  • +8 more secondary outcomes

Study Arms (2)

Side to side gastrojejunal reconstruction

EXPERIMENTAL

The post-operative care: usual practise Follow-up: 90 days postoperatively At Day 90: * a blood test for albumin and prealbumin * a GIQLI questionnaire (quality of life score) to be completed by the patient

Procedure: Reconstruction

Terminolateral gastrojejunal reconstruction

ACTIVE COMPARATOR

The post-operative care: usual practise Follow-up: 90 days postoperatively At Day 90: * a blood test for albumin and prealbumin * a GIQLI questionnaire (quality of life score) to be completed by the patient

Procedure: Reconstruction

Interventions

ReconstructionPROCEDURE

Lateral gastrojejunal Terminolateral gastrojejunal

Side to side gastrojejunal reconstructionTerminolateral gastrojejunal reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient over 18 years old
  • to benefit from a cephalic duodenopancreatectomy whatever the indication (benign and malignant tumor)
  • affiliated with a health insurance system
  • having received oral and written information about the protocol and having signed a free and informed written consent.

You may not qualify if:

  • associated organ resection except for portal vein or hepatic artery resection.
  • history of gastric or esophageal resection
  • person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
  • pregnant or breastfeeding women
  • patient participating in another clinical trial that may interfere with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Paoli Calmettes

Marseille, 13009, France

Location

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Interventions

Plastic Surgery Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 5, 2021

Study Start

July 7, 2021

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)