Esophageal Malignant Neoplasm PrimaryNCT07449208
Registry Study of People Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak
An observational study of Esophageal Malignant Neoplasm Primary and Anastomotic Leak, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The main purpose of this study is to look at how often anastomotic leaks happen in participants who are at high risk of these leaks and are eligible to receive gastric preconditioning by percutaneous angioembolization before an esophagectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Malignant Neoplasm Primary, Anastomotic Leak
- What is being tested?
- Esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Feb 2026to 25 Feb 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All study participants will be recruited from the Thoracic Surgery clinics at MSK. Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or the research team by screening of patient medical records to identify suitable research study participants. The study will be discussed with each eligible patient. All potential risks and benefits associated with the study will be discussed with the patient. All patients will be monitored by the enrolling investigator. All patients who meet the above criteria will be eligible irrespective of sex, gender, ethnicity, or smoking status. Before enrollment, all potential risks and benefits associated with the study will be discussed with the patient. Patients who do not consent to study enrollment will still be eligible for percutaneous gastric preconditioning and all standard of care management of their cancer.
Who may be able to join
- Documentation of Disease
- Patients must have pathologically confirmed esophageal malignancy requiring esophagectomy.
- Patients must also have risk factors for anastomotic leak:
- Previous foregut or bariatric surgery (gastric sleeve or gastric bypass), but excluding fundoplication-only surgery OR
- Salvage esophagectomy OR
- Planned cervical anastomosis OR
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- Two or more comorbidities:
- Diabetes, obesity, coronary artery disease, vascular disease (including celiac stricture or atherosclerosis, significant aortic disease, or any previous diagnosis of peripheral arterial disease), steroid use, hypertension, current or former smoker, renal insufficiency, and heart failure.
- Definition of Disease
- Patients must have pathologically confirmed esophageal malignancy requiring esophagectomy and risk factors for anastomotic leak, as described above.
- Patients must be candidate and have agreed to receive gastric preconditioning procedure
- Prior Treatment
- o There are no requirements with regard to prior treatment.
- Age ≥ 18
- ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria)
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Daniela Molena, MD, 212-639-3870
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725
Daniela Molena, MD, 212-639-3870
- Recruiting
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Daniela Molena, MD, 212-639-3870
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Daniela Molena, MD, 212-639-3870
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Daniela Molena, MD, 212-639-3870
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Daniela Molena, MD, 212-639-3870
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11553
Daniela Molena, MD, 212-639-3870
About this study
Official title: Gastric Preconditioning by Percutaneous Angioembolization Before Esophagectomy in Patients With a High Risk of Anastomotic Leak
The main purpose of this study is to look at how often anastomotic leaks happen in participants who are at high risk of these leaks and are eligible to receive gastric preconditioning by percutaneous angioembolization before an esophagectomy.
- Being tested
- Esophagectomy
- Keywords
- esophageal malignancy, esophagectomy, anastomotic leak, Memorial Sloan Kettering Cancer Center, 26-045
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
Eligible participants will undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization.
| Study group | Role | What they receive |
|---|---|---|
| Participants Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak | Participants who are undergoing preoperative gastric preconditioning by percutaneous angioembolization before esophagectomy for esophageal malignancy and who have a high risk of anastomotic leak Receives: Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anastomotic leak
Determine the incidence of anastomotic leak among participants with a high risk of esophageal leak who undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start25 Feb 2026
- Primary completion25 Feb 2029 (estimated)
- Study completion25 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Malignant Neoplasm PrimaryStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Molena, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449208
- Sponsor's protocol ID
- 26-045
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Preconditioning by Percutaneous Angioembolization Before Esophagectomy in Patients With a High Risk of Anastomotic Leak
- ClinicalTrials.gov ID
- NCT07449208
- Acronym / sponsor ID
- 26-045
- Keywords
- esophageal malignancy, esophagectomy, anastomotic leak, Memorial Sloan Kettering Cancer Center, 26-045
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 25 Feb 2029 (estimated)
- Study completion
- 25 Feb 2029 (estimated)
- First posted
- 4 Mar 2026 (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 main purpose of this study is to look at how often anastomotic leaks happen in participants who are at high risk of these leaks and are eligible to receive gastric preconditioning by percutaneous angioembolization before an esophagectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak | – | Procedure: EsophagectomyParticipants who are undergoing preoperative gastric preconditioning by percutaneous angioembolization before esophagectomy for esophageal malignancy and who have a high risk of anastomotic leak |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study participants will be recruited from the Thoracic Surgery clinics at MSK. Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or the research team by screening of patient medical records to identify suitable research study participants. The study will be discussed with each eligible patient. All potential risks and benefits associated with the study will be discussed with the patient. All patients will be monitored by the enrolling investigator. All patients who meet the above criteria will be eligible irrespective of sex, gender, ethnicity, or smoking status. Before enrollment, all potential risks and benefits associated with the study will be discussed with the patient. Patients who do not consent to study enrollment will still be eligible for percutaneous gastric preconditioning and all standard of care management of their cancer.
Key inclusion criteria (15 listed)
- Documentation of Disease
- Definition of Disease
- Prior Treatment
- o There are no requirements with regard to prior treatment.
- Age ≥ 18
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EsophagectomyEligible participants will undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization. | Procedure or surgery | Participants Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak |
Primary outcome
Incidence of anastomotic leak
Time frame: 1 year
Determine the incidence of anastomotic leak among participants with a high risk of esophageal leak who undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Daniela Molena, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Malignant Neoplasm Primary and Anastomotic Leak, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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 15 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Molena, MD (212-639-3870, molenad@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anastomotic leak (time frame: 1 year). 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 4 Mar 2026.