Esophageal CancerNCT06312839
Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric Conditioning
An observational study of Esophageal Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
This retrospective monocentric comparative study aims to assess the efficacy of preoperative ischemic conditioning, in preventing anastomotic leakage in esophageal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Collecting data from the medical record
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with non-metastatic oesophageal cancer, eligible for curative surgery by oesophagectomy.
Who may be able to join
- All patients older than 18 years with an indication for surgical esophagectomy with cervical anastomosis using the Lewis Santy technique or three stages approach.
Who cannot join
- Esophagectomy for ischemic or caustic oesophagitis, and patients lost for follow-up.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
Rémi Grange, MD
Sylvain Grange, MD
About this study
Official title: 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.
- Conditions
- Esophageal Cancer
- Being tested
- Collecting data from the medical record
- Keywords
- Embolization, Ischemic conditioning, Esophagectomy, Lewis Santy, Anastomotic leakage
- Medical subject headings
- Esophageal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting data from the medical recordOther
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 | Role | What they receive |
|---|---|---|
| Control group | Esophagectomy alone Receives: Other: Collecting data from the medical record | |
| Study Group | Preoperative ischemic conditioning before esophagectomy Receives: Other: Collecting data from the medical record |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day : 90
Secondary outcomes (6)
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.
Measured: 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.
Measured: Day : 90
Safety of ischemic gastric conditioning
Safety of ischaemic gastric filling will be analysed on the basis of imaging and data recordings.
Measured: 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.
Measured: Day : 90
Comparing hospital stay length
Hospital stay length will be analysed on the basis of data recordings.
Measured: Day : 90
Comparing postoperative mortality
Postoperative mortality will be analysed on the basis of data recordings.
Measured: Day : 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémi GRANGE, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312839
- Sponsor's protocol ID
- IRBN032024/CHUSTE
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric Conditioning : a Retrospective Monocentric Comparative Study
- ClinicalTrials.gov ID
- NCT06312839
- Acronym / sponsor ID
- IRBN032024/CHUSTE
- Conditions
- Esophageal Cancer
- Keywords
- Embolization, Ischemic conditioning, Esophagectomy, Lewis Santy, Anastomotic leakage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Collecting data from the medical recordEsophagectomy alone |
| Study Group | – | Other: Collecting data from the medical recordPreoperative ischemic conditioning before esophagectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with non-metastatic oesophageal cancer, eligible for curative surgery by oesophagectomy.
Key inclusion criteria (1 listed)
- All patients older than 18 years with an indication for surgical esophagectomy with cervical anastomosis using the Lewis Santy technique or three stages approach.
Key exclusion criteria (1 listed)
- Esophagectomy for ischemic or caustic oesophagitis, and patients lost for follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting data from the medical recordCollecting 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 | Other | Control group, Study Group |
Primary outcome
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.
6 secondary outcomes
Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.
Time frame: Day : 90
Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.
Time frame: Day : 90
Safety of ischemic gastric conditioning
Time frame: Day : 90
Hypertrophy of the gastroepiploic artery
Time frame: Day : 90
Comparing hospital stay length
Time frame: Day : 90
Comparing postoperative mortality
Time frame: Day : 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi GRANGE, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rémi GRANGE, MD ((0)477828963 ext. +33, remi.grange@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy. (time frame: Day : 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.