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

Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric Conditioning : a Retrospective Monocentric Comparative Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Other: Collecting data from the medical record

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Rémi GRANGE, MD; Phone Number: +33 (0)477828963; Email: remi.grange@chu-st-etienne.fr
• Study Contact Backup: Name: Sylvain Grange, MD; Phone Number: +33 (0)477829066; Email: grangesylvain@hotmail.fr

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • CHU de Saint-Etienne
    • Sub-Investigator: Sylvain GRANGE, MD
    • Principal Investigator: Rémi Grange, MD
    • Contact: Rémi Grange, MD
    • Sub-Investigator: Zoé Sahut, resident

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-metastatic oesophageal cancer, eligible for curative surgery by oesophagectomy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Esophagectomy alone	Other: 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
Study Group; Preoperative ischemic conditioning before esophagectomy	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.	Radiological confirmation by thoracoabdominal CT scan with oral contrast showing dehiscence of the oesophagastric anastomosis will be sought.	Day : 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.	Dehiscence confirmed by the surgeon during a repeat operation will be sought.	Day : 90
Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.	Endoscopic confirmation of an anastomotic leak will be sought.	Day : 90
Safety of ischemic gastric conditioning	Safety of ischaemic gastric filling will be analysed on the basis of imaging and data recordings.	Day : 90
Hypertrophy of the gastroepiploic artery	Hypertrophy of the gastroepiploic artery in embolized patients will be analysed on the basis of imaging and data recordings.	Day : 90
Comparing hospital stay length	Hospital stay length will be analysed on the basis of data recordings.	Day : 90
Comparing postoperative mortality	Postoperative mortality will be analysed on the basis of data recordings.	Day : 90

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Rémi GRANGE, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Anastomotic leakage; Embolization; Esophagectomy; Ischemic conditioning; Lewis Santy
• Other Study ID Numbers: IRBN032024/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No