Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.stent-in.nl

Contact information

Type

Scientific

Primary contact

Dr Jeanin van Hooft

ORCID ID

Contact details

Afd. Maag-
Darm- en Leverziekten
C2-220
Academisch Medisch Centrum
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
+31 (0)63 002 3579
info@stent-in.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1206

Study information

Scientific title

Acronym

Stent-in I study

Study hypothesis

1. Patients with incurable disseminated left-sided colonic cancer are better palliated by colonic stenting than surgery, measured by hospital free survival in "good health" (World Health Organization [WHO] score 0 or 1)
2. Colonic stenting is cost effective in patients with incurable disseminated left-sided colonic cancer

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Colonic cancer

Intervention

Surgical palliation versus "wait and see" policy and colonic stenting if obstruction is imminent.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Total hospital free survival in good health (corrected for days with a WHO performance status greater than 1)
2. Integral costs (product of volume consumed care and prices of means (personnel, overhead, material and investments)

Secondary outcome measures

1. Procedural related hospital stay and mortality and morbidity
2. Efficacy of palliation of (imminent) obstruction (complaints, secondary operation or stent placement)
3. Quality of life

Overall trial start date

01/12/2004

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Left sided colonic cancer (from left flexure to greater than 10 cm of anus)
2. Diagnosis histological proven
3. No signs of double tumour
4. Informed consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

180

Participant exclusion criteria

1. Potentially curable disease
2. American Society of Anaesthesiologists (ASA) IV or V
3. Ileus
4. Karnofsky index of less than 50%

Recruitment start date

01/12/2004

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Afd. Maag-, Darm- en Leverziekten, C2-220
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes