Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric Conditioning

NCT ID: NCT06312839

Last Updated: 2024-03-15

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

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-12-31

Brief Summary

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This retrospective monocentric comparative study aims to assess the efficacy of preoperative ischemic conditioning, in preventing anastomotic leakage in esophageal cancer surgery. Two groups were included : a surgery-alone group (control group) and a PreopAE group (study group) treated with an embolization procedure before esophagectomy. Collected data included patient characteristics, embolization procedure details, surgical outcomes, and postoperative complications.

The primary outcome was the efficacy of preoperative ischemic conditioning in preventing anastomotic leakage, assessed through CT scans. Secondary outcomes included analyzing safety of ischemic gastric conditioning, hypertrophy of the gastroepiploic artery in embolized patients and comparing hospital stay length and postoperative mortality.

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control group

Esophagectomy alone

Collecting data from the medical record

Intervention Type OTHER

Collecting data from the medical record:

* Gastroepiploic artery diameter before and after ischaemic preconditioning
* Postoperative mortality
* Complications related to embolisation and surgery
* Length of stay in intensive care unit and total length of hospital stay

Study Group

Preoperative ischemic conditioning before esophagectomy

Collecting data from the medical record

Intervention Type OTHER

Collecting data from the medical record:

* Gastroepiploic artery diameter before and after ischaemic preconditioning
* Postoperative mortality
* Complications related to embolisation and surgery
* Length of stay in intensive care unit and total length of hospital stay

Interventions

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Collecting data from the medical record

Collecting data from the medical record:

* Gastroepiploic artery diameter before and after ischaemic preconditioning
* Postoperative mortality
* Complications related to embolisation and surgery
* Length of stay in intensive care unit and total length of hospital stay

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients older than 18 years with an indication for surgical esophagectomy with cervical anastomosis using the Lewis Santy technique or three stages approach.

Exclusion Criteria

* Esophagectomy for ischemic or caustic oesophagitis, and patients lost for follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rémi GRANGE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU de Saint-Etienne

Saint-Priest-en-Jarez, , France

Site Status

Countries

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France

Central Contacts

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Rémi GRANGE, MD

Role: CONTACT

(0)477828963 ext. +33

Sylvain GRANGE, MD

Role: CONTACT

(0)477829066 ext. +33

Facility Contacts

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Rémi Grange, MD

Role: primary

Other Identifiers

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IRBN032024/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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