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
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
-
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.
-
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.
-
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.