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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01980394
Other study ID # Liestal-2012-OES
Secondary ID
Status Completed
Phase N/A
First received August 30, 2013
Last updated February 24, 2016
Start date May 2004
Est. completion date December 2013

Study information

Verified date February 2016
Source Kantonsspital Liestal
Contact n/a
Is FDA regulated No
Health authority Switzerland: Federal Office of Public Health
Study type Interventional

Clinical 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 anastomosis.


Description:

See study protocol!


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

- histologically confirmed cancer of gastro-esophageal junction with indication for surgery

Exclusion Criteria:

- missing informed consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Esophageal Stump Washout
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

Locations

Country Name City State
Switzerland Kantonsspital Baselland, Liestal Liestal Basel-Land

Sponsors (2)

Lead Sponsor Collaborator
Kantonsspital Liestal University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of intraluminal tumor cells in the remaining oesophageal stump during the operation Yes
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