Esophageal NeoplasmsNCT04994548
Endoscopic Resection of Early Esophageal Tumors in the Context of Cirrhosis or Portal Hypertension
An observational study of Esophageal Neoplasms and Cirrhosis, run by Central Hospital, Nancy, France.
Trial summary
Cirrhotic patients may be at high risk for esophageal cancer. Endoscopic resection is the standard treatment for superficial tumors. However, cirrhosis might be associated with upper gastrointestinal bleeding, particularly in case of portal hypertension or coagulopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms, Cirrhosis, Portal Hypertension
- What is being tested?
- Endosocpic resection of early esophageal tumor
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 31 Mar 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 112 patients with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor
Who may be able to join
- older than 18 years with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor
Who cannot join
- younger than 18
About this study
Official title: Endoscopic Resection of Early Esophageal Tumors in the Context of Cirrhosis or Portal Hypertension: a Multicenter Observational Study
Cirrhotic patients may be at high risk for esophageal cancer. Endoscopic resection is the standard treatment for superficial tumors. However, cirrhosis might be associated with upper gastrointestinal bleeding, particularly in case of portal hypertension or coagulopathy. This study aims to assess safety, efficacy and methods to prevent potential complications in cirrhosis or portal hypertension context for esophageal endoscopic resection.
This retrospective multicentric French-Belgian study includes all consecutive patients with cirrhosis or portal hypertension who underwent esophageal endoscopic resection from January 2005 to 2021.
- Conditions
- Esophageal Neoplasms, Cirrhosis, Portal Hypertension
- Being tested
- Endosocpic resection of early esophageal tumor
- Medical subject headings
- Esophageal Neoplasms, Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endosocpic resection of early esophageal tumorProcedure or surgery
under general anesthesia, by mucosectomy or endoscopic submucosal dissection
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic patients or with portal hypertension | Patients with early esophageal cancer Receives: Procedure: Endosocpic resection of early esophageal tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical success of early esophageal cancer resection
defined by a complete macroscopic resection
Measured: baseline
Secondary outcomes (4)
adverse events per procedure (immediate bleeding, perforation)
Measured: baseline
morbidity post procedure (delayed bleeding, infection, esophageal stenosis, 30-days related liver decompensation, 30-days related mortality)
Measured: up to 4 weeks
Potential risk factors for adverse events
Measured: baseline
preemptive methods to the risk of bleeding
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Jan 2005
- Primary completion3 Feb 2005
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994548
- Sponsor's protocol ID
- 2019PI67
- Status last verified
- Jul 2021
- First submitted
- 29 Jul 2021
- Last updated
- 6 Aug 2021
- 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 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Resection of Early Esophageal Tumors in the Context of Cirrhosis or Portal Hypertension: a Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT04994548
- Acronym / sponsor ID
- 2019PI67
- Conditions
- Esophageal Neoplasms, Cirrhosis, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 3 Feb 2005 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 6 Aug 2021 (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.
Cirrhotic patients may be at high risk for esophageal cancer. Endoscopic resection is the standard treatment for superficial tumors. However, cirrhosis might be associated with upper gastrointestinal bleeding, particularly in case of portal hypertension or coagulopathy. This study aims to assess safety, efficacy and methods to prevent potential complications in cirrhosis or portal hypertension context for esophageal endoscopic resection.
This retrospective multicentric French-Belgian study includes all consecutive patients with cirrhosis or portal hypertension who underwent esophageal endoscopic resection from January 2005 to 2021.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic patients or with portal hypertension | – | Procedure: Endosocpic resection of early esophageal tumorPatients with early esophageal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 112 patients with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor
Key inclusion criteria (1 listed)
- older than 18 years with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor
Key exclusion criteria (1 listed)
- younger than 18
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 |
|---|---|---|
| Endosocpic resection of early esophageal tumorunder general anesthesia, by mucosectomy or endoscopic submucosal dissection | Procedure or surgery | Cirrhotic patients or with portal hypertension |
Primary outcome
technical success of early esophageal cancer resection
Time frame: baseline
defined by a complete macroscopic resection
4 secondary outcomes
adverse events per procedure (immediate bleeding, perforation)
Time frame: baseline
morbidity post procedure (delayed bleeding, infection, esophageal stenosis, 30-days related liver decompensation, 30-days related mortality)
Time frame: up to 4 weeks
Potential risk factors for adverse events
Time frame: baseline
preemptive methods to the risk of bleeding
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms and Cirrhosis, run by Central Hospital, Nancy, 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: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
technical success of early esophageal cancer resection (time frame: baseline). 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 6 Aug 2021.