Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2024-10-01

Brief Summary

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

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Detailed Description

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Delayed gastric emptying is one of the main complications occurring after pancreatodudodenectomy, the incidence of which is estimated between 10 and 40% in the literature. Its occurrence leads to an alteration in post-operative quality of life (maintenance or resting of the nasogastric tube) and is the primary reason an increase in the length of hospital stay and therefore the cost of treatment. In addition, it predisposes to the risk of inhalation pneumopathy, which increases the risk of post-operative death. Various technical surgical points have been suggested by retrospective studies to reduce its incidence (pyloric preservation, respect for the left gastric vein, ante-colic positioning of the Child's handle, making a Y-shaped handle) but without ever being validated in randomized prospective studies.

Recently three retrospective studies have highlighted the interest of performing a side to side l rather than an end to side gastro-jejunal anastomosis to reduce the rate of post-operative delayed gastric emptying.

Conditions

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Surgical Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Side to side gastrojejunal reconstruction

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

Group Type EXPERIMENTAL

Reconstruction

Intervention Type PROCEDURE

Lateral gastrojejunal Terminolateral gastrojejunal

Terminolateral gastrojejunal reconstruction

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

Group Type ACTIVE_COMPARATOR

Reconstruction

Intervention Type PROCEDURE

Lateral gastrojejunal Terminolateral gastrojejunal

Interventions

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Reconstruction

Lateral gastrojejunal Terminolateral gastrojejunal

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No