Operable Esophageal CancerNCT06453031
Gastric Ischemic Preconditioning Before Esophagectomy
An observational study of Operable Esophageal Cancer and Embolization of the Left Gastric Artery Prior to Surgery, run by CHU Rennes - Hopital Pontchaillou at 1 site in France.
Trial summary
The aim of the study is to investigate the impact of left gastric artery embolization before esophagectomy on postoperative complications, particularly anastomotic leaks and necrosis of the gastric conduit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Operable Esophageal Cancer, Embolization of the Left Gastric Artery Prior to Surgery
- What is being tested?
- Gastric Ischemic Preconditioning Before Esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2024to Jun 2025
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with operable esophageal cancer who underwent embolization of the left gastric artery prior to surgery.
Who may be able to join
- Patient with operable esophageal cancer who underwent embolization of the left gastric artery prior to surgery.
Who cannot join
- Patient with no operable esophageal cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Outcomes of Gastric Ischemic Preconditioning Before Esophagectomy With Preoperative Embolization of the Left Gastric Artery: A Prospective Single-Center Study
The aim of the study is to investigate the impact of left gastric artery embolization before esophagectomy on postoperative complications, particularly anastomotic leaks and necrosis of the gastric conduit.
- Being tested
- Gastric Ischemic Preconditioning Before Esophagectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Ischemic Preconditioning Before EsophagectomyProcedure or surgery
Does embolization of the left gastric artery prior oesophagectomy reduce postoperative complications, particularly anastomotic leaks and ischemia of the gastric conduit?
| Study group | Role | What they receive |
|---|---|---|
| Patient who underwent Gastric Ischemic Preconditioning Before Esophagectomy | Patient with operable esophageal cancer who underwent embolization of the left gastric artery prior to surgery Receives: Procedure: Gastric Ischemic Preconditioning Before Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak
Measured: 6 months
Anastomotic stenosis
Measured: 6 months
Gastric conduit necrosis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operable 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
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- CHU Rennes - Hopital Pontchaillou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIVIN Marie, CHU Rennes - Hopital Pontchaillou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453031
- Sponsor's protocol ID
- CHU Pontchaillou Rennes
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcomes of Gastric Ischemic Preconditioning Before Esophagectomy With Preoperative Embolization of the Left Gastric Artery: A Prospective Single-Center Study
- ClinicalTrials.gov ID
- NCT06453031
- Acronym / sponsor ID
- CHU Pontchaillou Rennes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CHU Rennes - Hopital PontchaillouUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 11 Jun 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.
The aim of the study is to investigate the impact of left gastric artery embolization before esophagectomy on postoperative complications, particularly anastomotic leaks and necrosis of the gastric conduit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient who underwent Gastric Ischemic Preconditioning Before Esophagectomy | – | Procedure: Gastric Ischemic Preconditioning Before EsophagectomyPatient with operable esophageal cancer who underwent embolization of the left gastric artery prior to surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with operable esophageal cancer who underwent embolization of the left gastric artery prior to surgery.
Key inclusion criteria (1 listed)
- Patient with operable esophageal cancer who underwent embolization of the left gastric artery prior to surgery.
Key exclusion criteria (1 listed)
- Patient with no operable esophageal cancer
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 |
|---|---|---|
| Gastric Ischemic Preconditioning Before EsophagectomyDoes embolization of the left gastric artery prior oesophagectomy reduce postoperative complications, particularly anastomotic leaks and ischemia of the gastric conduit? | Procedure or surgery | Patient who underwent Gastric Ischemic Preconditioning Before Esophagectomy |
Primary outcome
Anastomotic leak
Time frame: 6 months
Anastomotic stenosis
Time frame: 6 months
Gastric conduit necrosis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Operable Esophageal Cancer and Embolization of the Left Gastric Artery Prior to Surgery, run by CHU Rennes - Hopital Pontchaillou 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 11 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak (time frame: 6 months). The study lists 3 primary outcomes in all. 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 11 Jun 2024.