NCT01980394

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

9.6 years

First QC Date

August 30, 2013

Last Update Submit

February 24, 2016

Conditions

Esophageal CancerGastrooesophageal Cancer

Keywords

esophagusgastro-esophegeal junctioncancertumor seedingfree viable tumor cellssurgeryintraluminal tumor cellsstump washout

Outcome Measures

Primary Outcomes (1)

  • Presence of intraluminal tumor cells in the remaining oesophageal stump

    during the operation

Study Arms (1)

prospective cohort study

OTHER
Procedure: Esophageal Stump Washout

Interventions

Esophageal Stump WashoutPROCEDURE

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

prospective cohort study

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Baselland, Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

Location

MeSH Terms

Conditions

Esophageal NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Christoph A. Maurer, Professor, Chairman of Surgery

    Hospital of Liestal, Liestal, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2013

First Posted

November 11, 2013

Study Start

May 1, 2004

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

CH(1)