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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312839
• Other study ID #: IRBN032024/CHUSTE
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Rémi GRANGE, MD
• Phone: (0)477828963
• Email: remi.grange[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

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

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Safety of ischemic gastric conditioning	Safety of ischaemic gastric filling will be analysed on the basis of imaging and data recordings.	Day : 90
Secondary	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
Secondary	Comparing hospital stay length	Hospital stay length will be analysed on the basis of data recordings.	Day : 90
Secondary	Comparing postoperative mortality	Postoperative mortality will be analysed on the basis of data recordings.	Day : 90