Condition category
Digestive System
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
10/10/2014
Prospective/Retrospective
Prospectively 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 Ilja Peute

ORCID ID

Contact details

Academic Medical Center
Department of Gastroenterology
C2
P.O. Box 22700
Amsterdam
1100 DE
Netherlands
+31 (0)63 002 3579
info@stent-in.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Stent-in 2 study

Study hypothesis

Which treatment strategy is the most effective for patients with acute left-sided malignant colonic obstruction: either colonic stenting followed by elective surgery or emergency surgery.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled parallel-group multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute left-sided malignant colonic obstruction

Intervention

Patients will be randomised to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Effectiveness of both strategies in terms of quality of life, morbidity and mortality.

Secondary outcome measures

Costs of both strategies.

Overall trial start date

01/01/2007

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Symptoms of left-sided malignant colonic obstruction existing less than one week defined as obstructive symptoms with dilation of the colon on plain abdominal X-ray and typical abnormalities on a gastrografin enema study compatible with a malignant colonic stricture
2. Aged more than 18 years
3. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

1. Peritonitis, perforation, fever, sepsis or other serious complications demanding urgent surgery
2. American Society of Anesthesiologists (ASA) IV or V
3. Obstruction due to non-colonic malignancies or from a benign origin
4. Distal tumor margin less than 10 cm from the anal verge

Recruitment start date

01/01/2007

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DE
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Center (AMC) (The Netherlands)

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

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

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17608947
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21398178
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25298250

Publication citations

  1. Protocol

    van Hooft JE, Bemelman WA, Breumelhof R, Siersema PD, Kruyt PM, van der Linde K, Veenendaal RA, Verhulst ML, Marinelli AW, Gerritsen JJ, van Berkel AM, Timmer R, Grubben MJ, Scholten P, Geraedts AA, Oldenburg B, Sprangers MA, Bossuyt PM, Fockens P, Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study)., BMC Surg, 2007, 7, 12, doi: 10.1186/1471-2482-7-12.

  2. Results

    van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P, , Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial., Lancet Oncol., 2011, 12, 4, 344-352, doi: 10.1016/S1470-2045(11)70035-3.

  3. Results

    Sloothaak DA, van den Berg MW, Dijkgraaf MG, Fockens P, Tanis PJ, van Hooft JE, Bemelman WA, , , Oncological outcome of malignant colonic obstruction in the Dutch Stent-In 2 trial., Br J Surg, 2014, 101, 13, 1751-1757, doi: 10.1002/bjs.9645.

Additional files

Editorial Notes