Esophageal Stump Washout

Esophageal Cancer Clinical Trial

Official title:

Esophageal Stump Washout Reduces Free Intraluminal Tumor Cells During Resection of Carcinomas of the Esophagus and Cardia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980394
• Other study ID #: Liestal-2012-OES
• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastrooesophageal Cancer

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