|- candidate number||18301|
|- NTR Number||NTR4673|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jul-2014|
|- Secondary IDs||W14_164#14.17.0205 Medisch Ethische Toetsingscommissie AMC|
|- Public Title||Evidence-based treatment of patients with acute large bowel obstruction caused by colon cancer of the left colon: Applying a clinical decision guideline|
|- Scientific Title||Evidence-based treatment of patients with acute left-sided malignant colonic obstruction: Applying a clinical decision guideline|
|- hypothesis||Elderly patients of 70 years and older with acute malignant left-sided colonic obstruction will have a better treatment outcome with the ‘bridge to surgery’ method by means of a colonic stent or transverse colostomy.|
|- Healt Condition(s) or Problem(s) studied||Colon cancer, Stent, Older adults|
|- Inclusion criteria||Patients with symptomatic malignant obstruction of the left colon (including the splenic flexure, descending colon and sigmoid) caused by colonic cancer who require an urgent intervention to alleviate the obstruction.|
|- Exclusion criteria||- Suspicion of peritonitis due to perforation (tumour or cecum blow out). |
- Patients with benign disease at pathology.
- Patients with obstruction caused by extracolonic malignancy.
- Patients with malignant obstruction of the right colon, i.e. proximal to the splenic flexure.
- Patients with obstruction caused by rectal cancer, as defined within 10 cm of the anal verge for this protocol.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2015|
|- planned closingdate||1-jan-2018|
|- Target number of participants||195|
|- Interventions||1. Patients younger than 70 years will have surgical resection. Exceptions can be made for those who have (1) an indication for neo-adjuvant treatment, (2) severe comorbidities, and (3) incurable metastatic disease; they should receive a decompressing intervention.|
2. Patients aged 70 years and older without incurable metastatic disease will initially have non-resectional decompression followed by elective resection (bridge to surgery treatment):
A) Patients with a malignant stenosis < 40 mm are eligible for colonic stent placement, which will be performed by an experienced gastroenterologist.
B) If stent insertion failed, if stricture characteristics are unfavourable for stent placement, or if systemic anti-angiogenic therapy is intended, a minimally invasive transverse loop colostomy is constructed.
Patients eligible for elective resection will be operated at least 7 days after initial decompression and no later than 4 weeks after initial presentation.
3. Patients of all ages with incurable extensive metastatic disease or patients who are unfit to undergo surgical resection will be treated palliatively by stent placement or a diverting colostomy. Patients who are fit enough to have palliative chemotherapy are best treated with a colostomy in case anti-angiogenic therapy will be administered because of the risk of tumour perforation when having a stent in situ.
|- Primary outcome||In-hospital and 30-day mortality rate in the elderly patients (≥ 70 years).|
|- Secondary outcome||- Morbidity and stoma rates.|
- The technical and clinical success rates, incidence of guidewire and stent perforation and morbidity of delayed surgery of colorectal stenting.
- The oncologic quality of surgical resection in terms of lymph node harvest and radicality.
- Outcome (morbidity, mortality, stoma rates, survival) of conservative, non-resectional management of patients with incurable disease or high operative risk that are treated according to the clinical decision guideline with either a colorectal stent or stoma alone.
|- Timepoints||Primary and secondary outcomes will be measured during hospital admission and during regular oncologic follow-up visits at the outpatient clinic according to the Dutch guideline on colorectal carcinoma.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD E.E. Halsema, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. Jeanin Hooft, van|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||This is a Dutch, multicenter, prospective validation study of a clinical decision guideline for the treatment of patients with acute, left-sided, colonic cancer obstruction. According to the guideline, patients are divided into three groups:|
1) Patients younger than 70 years will have emergency resection. Exceptions can be made for those who have an indication for neo-adjuvant treatment, severe comorbidities and incurable metastatic disease; they should receive a decompressing intervention.
2) Potentially curable patients of 70 years and older will have bridge to surgery treatment by colonic stent placement or transverse loop colostomy, depending on the stricture characteristics and the intention to start anti-angiogenic therapy.
3) Patients with incurable extensive metastatic disease or patients who are unfit to undergo surgical resection will be treated palliatively by stent placement or a diverting colostomy.
The primary outcome is 30-day mortality in the group of elderly patients (≥ 70 years).
|- Main changes (audit trail)|
|- RECORD||7-jul-2014 - 3-aug-2014|