Colonic stenting or surgery in left-sided colonic obstruction for disseminated incurable colorectal cancer: a multicenter randomised trial

ISRCTN	ISRCTN01790428
DOI	https://doi.org/10.1186/ISRCTN01790428
Secondary identifying numbers	1206

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 15/07/2021

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Jeanin van Hooft
Scientific

Afd. Maag-, Darm- en Leverziekten, C2-220
Academisch Medisch Centrum
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)63 002 3579
Email	info@stent-in.nl

Study information

Study design	Multicentre, randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Colonic stenting or surgery in left-sided colonic obstruction for disseminated incurable colorectal cancer: a multicenter randomised trial
Study acronym	Stent-in I study
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Colonic cancer
Intervention	Surgical palliation versus "wait and see" policy and colonic stenting if obstruction is imminent.
Intervention type	Other
Primary outcome measure	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 study start date	01/12/2004
Completion date	01/01/2008
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	180
Total final enrolment	21
Key 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
Key exclusion criteria	1. Potentially curable disease 2. American Society of Anaesthesiologists (ASA) IV or V 3. Ileus 4. Karnofsky index of less than 50%
Date of first enrolment	01/12/2004
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Afd. Maag-, Darm- en Leverziekten, C2-220

Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre

Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	premature closure results	04/11/2006	15/07/2021	Yes	No

Editorial Notes

15/07/2021: The trial was stopped due to a high number of serious adverse events. Publication reference and total final enrolment added.