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

NCT06312839 | Not Yet Recruiting

• 1 other identifier: IRBN032024/CHUSTE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

Embolization; Ischemic conditioning; Esophagectomy; Lewis Santy; Anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.

  Day : 90

• Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.

  Day : 90

• Safety of ischemic gastric conditioning

  Day : 90

• Hypertrophy of the gastroepiploic artery

  Day : 90

• Comparing hospital stay length

  Day : 90

Study Arms (2)

Control group

Esophagectomy alone

Other: Collecting data from the medical record

Study Group

Preoperative ischemic conditioning before esophagectomy

Other: Collecting data from the medical record

Interventions

Collecting data from the medical record 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

Control group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Esophagectomy for ischemic or caustic oesophagitis, and patients lost for follow-up.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rémi GRANGE, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rémi GRANGE, MD

CONTACT

(0)477828963; remi.grange@chu-st-etienne.fr

Sylvain GRANGE, MD

CONTACT

(0)477829066; grangesylvain@hotmail.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 15, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)