- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06312839
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
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
-
-
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Saint-Priest-en-Jarez, France, 42270
- CHU de Saint-Etienne
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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
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
Esophagectomy alone
|
Collecting data from the medical record:
|
Study Group
Preoperative ischemic conditioning before esophagectomy
|
Collecting data from the medical record:
|
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.
Time Frame: Day : 90
|
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.
Time Frame: Day : 90
|
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.
Time Frame: Day : 90
|
Endoscopic confirmation of an anastomotic leak will be sought.
|
Day : 90
|
Safety of ischemic gastric conditioning
Time Frame: Day : 90
|
Safety of ischaemic gastric filling will be analysed on the basis of imaging and data recordings.
|
Day : 90
|
Hypertrophy of the gastroepiploic artery
Time Frame: Day : 90
|
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
Time Frame: Day : 90
|
Hospital stay length will be analysed on the basis of data recordings.
|
Day : 90
|
Comparing postoperative mortality
Time Frame: Day : 90
|
Postoperative mortality will be analysed on the basis of data recordings.
|
Day : 90
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rémi GRANGE, MD, CHU de Saint-Etienne
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRBN032024/CHUSTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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