Esophageal CancerNCT01980394
Esophageal Stump Washout
A study testing Esophageal Stump Washout in people with Esophageal Cancer and Gastrooesophageal Cancer, run by Kantonsspital Liestal at 1 site in Switzerland.
Trial summary
Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the esophagus and the cardia. The aim of the the study was to establish a method of mechanical lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer cells before doing the esophageal… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Esophageal Cancer, Gastrooesophageal Cancer
- What is being tested?
- Esophageal Stump Washout
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2004to Dec 2013
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed cancer of gastro-esophageal junction with indication for surgery
Who cannot join
- missing informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Baselland, Liestal
Liestal, Basel-Landschaft, 4410
About this study
Official title: Esophageal Stump Washout Reduces Free Intraluminal Tumor Cells During Resection of Carcinomas of the Esophagus and Cardia
Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the esophagus and the cardia. The aim of the the study was to establish a method of mechanical lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer cells before doing the esophageal anastomosis.
Read the detailed description
See study protocol!
- Conditions
- Esophageal Cancer, Gastrooesophageal Cancer
- Being tested
- Esophageal Stump Washout
- Keywords
- esophagus, gastro-esophegeal junction, cancer, tumor seeding, free viable tumor cells, surgery, intraluminal tumor cells, stump washout
- Medical subject headings
- Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal Stump WashoutProcedure or surgery
a washout of the closed esophageal stump with Ringer-solution (10 times 30ml) is performed by means of a transorally inserted 24F-Foley catheter. The first, fifth and tenth portion of the lavage fluid are collected and sent to cytological examination
| Study group | Role | What they receive |
|---|---|---|
| prospective cohort study | Other | Not described Receives: Procedure: Esophageal Stump Washout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of intraluminal tumor cells in the remaining oesophageal stump
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startMay 2004
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Liestal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Christoph A. Maurer, Professor, Chairman of Surgery, Study chair, Hospital of Liestal, Liestal, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980394
- Sponsor's protocol ID
- Liestal-2012-OES
- Status last verified
- Feb 2016
- First submitted
- 30 Aug 2013
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Maurer CA, Walensi M, Mattiello D, Kaser SA, Zarfl K, Egger C. Intraoperative esophageal washout reduces free intraluminal tumor cells during resection of carcinomas of the esophagus and cardia. Eur J Surg Oncol. 2024 Apr;50(4):108017. doi: 10.1016/j.ejso.2024.108017. Epub 2024 Feb 11.
PubMed 38377885
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Stump Washout Reduces Free Intraluminal Tumor Cells During Resection of Carcinomas of the Esophagus and Cardia
- ClinicalTrials.gov ID
- NCT01980394
- Acronym / sponsor ID
- Liestal-2012-OES
- Conditions
- Esophageal Cancer, Gastrooesophageal Cancer
- Keywords
- esophagus, gastro-esophegeal junction, cancer, tumor seeding, free viable tumor cells, surgery, intraluminal tumor cells, stump washout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kantonsspital LiestalUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- May 2004
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Nov 2013 (estimated)
- 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.
Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the esophagus and the cardia. The aim of the the study was to establish a method of mechanical lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer cells before doing the esophageal anastomosis.
Detailed description
See study protocol!
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prospective cohort study | Other | Procedure: Esophageal Stump Washout |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histologically confirmed cancer of gastro-esophageal junction with indication for surgery
Key exclusion criteria (1 listed)
- missing informed consent
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 |
|---|---|---|
| Esophageal Stump Washouta washout of the closed esophageal stump with Ringer-solution (10 times 30ml) is performed by means of a transorally inserted 24F-Foley catheter. The first, fifth and tenth portion of the lavage fluid are collected and sent to cytological examination | Procedure or surgery | prospective cohort study |
Primary outcome
Presence of intraluminal tumor cells in the remaining oesophageal stump
Time frame: during the operation
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 25 Feb 2016.
- Derived from this study: PubMed 38377885Maurer CA, Walensi M, Mattiello D, Kaser SA, Zarfl K, Egger C. Intraoperative esophageal washout reduces free intraluminal tumor cells during resection of carcinomas of the esophagus and cardia. Eur J Surg Oncol. 2024 Apr;50(4):108017. doi: 10.1016/j.ejso.2024.108017. Epub 2024 Feb 11.
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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.
Christoph A. Maurer, Professor, Chairman of Surgery study chair
Hospital of Liestal, Liestal, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal Stump Washout in people with Esophageal Cancer and Gastrooesophageal Cancer, run by Kantonsspital Liestal at 1 site in Switzerland.
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 25 Feb 2016. 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 Switzerland. 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?
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?
Presence of intraluminal tumor cells in the remaining oesophageal stump (time frame: during the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01980394, which also lists 1 linked publication.
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 25 Feb 2016.