A substantial proportion of patients diagnosed with colorectal cancer present with a colonic obstruction, which is conventionally treated with emergency surgery. This is a complex procedure and the operations are associated with significant mortality and morbidity, even when patients receive the best peri-operative care. In particular, patients may be left with permanent stomas that reduce their quality of life.
Colonic stenting, which has been available since the 1990s, can be used as a pre-operative palliative procedure to bypass obstructions where these occur on the left side of the colon. This is usually followed by elective (non-emergency) surgery; sometimes, however, the initial endoscopy reveals either that the obstruction is benign and surgery un-necessary, or that the disease is too disseminated for surgery to be appropriate. Jeanin van Hooft of the Academic Medical Centre at the University of Amsterdam, the Netherlands and colleagues from the collaborative Dutch In-Stent study group have now performed the first randomised controlled trial comparing colonic stenting followed by elective surgery with emergency surgery in patients with this condition[1].
A total of 98 patients presenting at Dutch hospitals with an acute left-sided colonic obstruction that was believed to be due to cancer were enrolled in the trial and assigned at random to receive either stenting followed by elective surgery or the current standard of care. Clearly, treatment assignment could not be masked to either the patients or their surgeons. Elective surgery on patients in the stenting arm was performed as soon as feasible and not more than four weeks after stent placement. All patients were monitored using the European Organisation for the Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-30) during a six-month follow-up period. Health-related quality of life was taken as the primary outcome, with morbidity, mortality, stoma rate and other quality-of-life dimensions as secondary outcomes.
After the first month of follow-up, a difference between the arms became apparent with patients in the stenting arm experiencing more early morbidity and some mortality compared to those who had received emergency surgery. Following standard procedures, the study was suspended for analysis of interim data and officially ended in March 2010 after all enrolled patients had completed the follow-up procedure. The interim analysis revealed an absolute increased risk of morbidity 30 days after treatment initiation in the stenting arm, with an absolute risk increase of 0.19 (95% CI -0.01 to 0.37) for the first ninety patients. However, no differences in global health status or in the secondary outcomes of mortalit, morbidity and stoma rate were recorded between the groups after the complete follow-up period. The most common serious adverse events were abscess in both groups, and perforations and anastomotic leakage in the stenting group only. Perforations are particularly serious in cancer patients as they can cause tumour spread.
Van Hooft and colleagues in the Dutch In-Stent study group concluded that there was no advantage, and very likely some short-term disadvantage, in offering colonic stenting followed by elective surgery as an alternative to emergency surgery in patients presenting with colonic obstruction and a likely diagnosis of colon cancer. However, they recommended that further trials would be useful to investigate whether the former procedure has advantages in some patient subsets. Even this must be treated with caution, however, because of the risk of perforations.
Reference
van Hooft, J.E., Bemelman, W.A., Oldenburg, B., Marinelli, A.W., Holzik, M.F., Grubben, M.J., Sprangers, M.A., Dijkgraaf, M.G. and Fockens P., for the collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncology 12(4): 344-352. doi:10.1016/S1470-2045(11)70035-3
[1] Registered study, reference # ISRCTN46462267
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