Elsevier

The Lancet Oncology

Volume 12, Issue 4, April 2011, Pages 344-352
The Lancet Oncology

Articles
Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial

https://doi.org/10.1016/S1470-2045(11)70035-3Get rights and content

Summary

Background

Colonic stenting as a bridge to elective surgery is an alternative for emergency surgery in patients with acute malignant colonic obstruction, but its benefits are uncertain. We aimed to establish whether colonic stenting has better health outcomes than does emergency surgery.

Methods

Patients with acute obstructive left-sided colorectal cancer were enrolled from 25 hospitals in the Netherlands and randomly assigned (1:1 ratio) to receive colonic stenting as a bridge to elective surgery or emergency surgery. The randomisation sequence was computer generated with permuted blocks and was stratified by centre; treatment allocation was concealed by use of a web-based application. Investigators and patients were unmasked to treatment assignment. The primary outcome was mean global health status during a 6-month follow-up, which was assessed with the QL2 subscale of the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-C30). Analysis was by intention to treat. This study is registered, number ISRCTN46462267.

Findings

Between March 9, 2007, and Aug 27, 2009, 98 patients were assigned to receive colonic stenting (n=47 patients) or emergency surgery (n=51). Two successive interim analyses showed increased 30-day morbidity in the colonic stenting group, with an absolute risk increase of 0·19 (95% CI −0·06 to 0·41) in analysis of the first 60 patients (14 of 28 patients receiving colonic stenting vs 10 of 32 receiving emergency surgery), and an absolute risk increase of 0·19 (−0·01 to 0·37) in analysis of the first 90 patients (23 of 47 patients vs 13 of 43). In accordance with the advice of the data safety monitoring committee, the study was suspended on Sept 18, 2009, and ended on March 12, 2010. At the final analysis of 98 patients, mean global health status during follow-up was 63·0 (SD 23·8) in the colonic stenting group and 61·4 (SD 21·9) in the emergency surgery group; after adjustment for baseline values, mean global health status did not differ between treatment groups (−4·7, 95% CI −14·8 to 5·5, p=0·36). No difference was recorded between treatment groups in 30-day mortality (absolute risk difference −0·01, 95% CI −0·14 to 0·12, p=0·89), overall mortality (−0·02, −0·17 to 0·14, p=0·84), morbidity (−0·08, −0·27 to 0·11, p=0·43), and stoma rates at latest follow-up (0·09, −0·10 to 0·27, p=0·35). However, the emergency surgery group had an increased stoma rate directly after initial intervention (0·23, 0·04 to 0·40, p=0·016) and a reduced frequency of stoma-related problems (between-group difference −12·0, −23·7 to −0·2, p=0·046). The most common serious adverse events were abscess (three in the colonic stenting group vs four in the emergency surgery group), perforations (six vs none), and anastomotic leakage (five vs one), and the most common adverse events were pneumonia (three vs one) and wound infection (one vs three).

Interpretation

Colonic stenting has no decisive clinical advantages to emergency surgery. It could be used as an alternative treatment in as yet undefined subsets of patients, although with caution because of concerns about tumour spread caused by perforations.

Funding

None.

Introduction

Colorectal cancer is a common cancer, with 412 900 new cases and 207 400 deaths in Europe in 2006.1 7–29% of patients with colorectal cancer present with a bowel obstruction.2, 3 Conventionally, these patients receive emergency surgery to restore luminal patency. Emergency operations are associated with mortality in 15–34% of patients and morbidity in 32–64%, despite advances in perioperative care.3, 4, 5, 6, 7 Several surgical techniques can be used to treat this disorder. Usually, an ostomy is created with the intention of secondary closure, but in many patients, these ostomies will not be closed.2, 5 Patients with a permanent stoma frequently report complications and poorer health-related quality of life than do patients without colostomy.8, 9, 10, 11

In the early 1990s, colonic stenting was introduced to restore luminal patency in patients with malignant obstruction of the left side of the colon. Stent placement before elective surgery, also known as a bridge to surgery, improved the clinical condition of the patient and seemed to decrease mortality, morbidity, and number of colostomies in uncontrolled studies.5, 6, 12, 13 Additionally, this temporary procedure enables accurate tumour staging and prevents the need for surgery in patients with disseminated disease or unacceptable surgical risk. In these patients, the colonic stent can serve as permanent palliation. In a systematic review of 54 uncontrolled trials and case reports, self-expandable metal stents were technically successful in 91·9% of patients and clinically successful in 71·7% of patients when used as a bridge to surgery.14 Major stent-procedure and stent-related complications were perforation (3·8%), stent migration (11·8%) and reobstruction (7·3%). The stent-procedure related mortality was less than 1%.14 Perforation is a particular threat because it can lead to subsequent peritoneal tumour spill, changing a potentially curable disease into an incurable one.

Until now, colonic stenting has mainly been undertaken by experts in tertiary centres and published results are often retrospective or uncontrolled. Stent insertion needs to be properly assessed in randomised controlled trials.15 We did a randomised assessment of colonic stenting versus emergency surgery, with respect to global health status, mortality, morbidity, other quality-of-life dimensions, and stoma rates.

Section snippets

Patients

Patients presenting with an acute left-sided colorectal obstruction presumed to be caused by a colonic malignancy were enrolled consecutively from 25 participating Dutch hospitals (four university and 21 non-university teaching hospitals). Eligible patients were aged 18 years or older, had clinical signs of severe colonic obstruction that had existed for less than 1 week, and had dilation of the colon on either plain abdominal radiograph, with typical abnormalities on a gastrografin enema

Results

Between March 9, 2007, and Aug 27, 2009, 98 patients (mean age 71·0 years [SD 10·8]) were enrolled from 25 centres and randomly assigned to receive colonic stenting or emergency surgery (figure 1). Demographic and clinical characteristics were balanced between treatment groups at baseline (table 1). Two protocol violations occurred. One patient refused emergency surgery and was treated with a colonic stent followed by uneventful elective surgery. One endoscopist refused to do endoscopy because

Discussion

In this multicentre randomised trial, colonic stenting or emergency surgery did not have any distinct benefits for global health status, mortality, morbidity, other quality-of-life dimensions, and stoma rates. These results are less favourable than are previous data obtained from comparative non-randomised,4, 5, 13 matched controlled,6, 12 and non-comparative studies14, 25 (panel).

We might have selected a population at increased risk for complications: 70% of patients presented with a complete

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