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

Not yet recruiting

• Conditions: Esophageal Cancer
• Interventions: Other: Collecting data from the medical record

• Registration Number: NCT06312839
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Study Start: 2024-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Collecting data from the medical record	Preoperative ischemic conditioning before esophagectomy
Control group	Collecting data from the medical record	Esophagectomy alone

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety of ischemic gastric conditioning	Day : 90	Safety of ischaemic gastric filling will be analysed on the basis of imaging and data recordings.
Comparing hospital stay length	Day : 90	Hospital stay length will be analysed on the basis of data recordings.
Comparing postoperative mortality	Day : 90	Postoperative mortality will be analysed on the basis of data recordings.
Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.	Day : 90	Endoscopic confirmation of an anastomotic leak will be sought.
Hypertrophy of the gastroepiploic artery	Day : 90	Hypertrophy of the gastroepiploic artery in embolized patients will be analysed on the basis of imaging and data recordings.

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Priest-en-Jarez, France