Report of the Clinical Protocol Committee: Development of Randomized Trials for Malignant Bowel Obstruction

Abstract

Malignant bowel obstruction (MBO) is a commonly encountered palliative care problem. There have been very few comparative trials in this area, and consequently there is very little clinical evidence upon which therapy can be rationally based. The purpose of this paper is to highlight the discussion and decision-making process that was undertaken by the Clinical Protocol Subcommittee during the development of a proposed clinical trial of best medical care versus surgical or endoscopic treatment for MBO. The development of the proposed clinical trials followed an orderly process. The first step taken was a discussion of a specific definition for MBO. Once agreed upon, this definition helped identify inclusion and exclusion criteria for the proposed trial. This was followed by an extensive literature review, which helped define both surgical and endoscopic approaches to MBO as well as what constituted best medical care. An extensive discussion was then undertaken concerning the best outcome measure of success for medical, surgical, and endoscopic interventions. All of the above steps culminated in two proposed protocols, one for MBO of the small intestine distal to the ligament of Treitz and a second for colonic obstructions. The small intestinal trial is designed to compare surgical intervention versus best medical care, whereas the colonic trial seeks to compare surgery with endoscopically-placed intraluminal stents coupled with best medical care.

Predictors of survival in patients with non‐curative stage IV cancer and malignant bowel obstruction

“…A recent consensus conference defined malignant bowel obstruction (MBO) as a bowel obstruction beyond the ligament of Treitz that is either from an intra-abdominal primary cancer with incurable disease or from a non-intra-abdominal primary cancer with clear intra-peritoneal disease [1]. MBO occurs in up to 15% of patients admitted to palliative care wards and in 10-28% of patients diagnosed with colorectal cancer and management can be clinically challenging [2] [3].…”

Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial

“…Currently, little highlevel evidence is available, with only one published randomized trial comparing emergency surgery and SEMS insertion followed by elective surgery [14]. Two protocols of randomized trials also have been published [15,16], but no results have been reported to date.…”

Outcome of decompression using a transnasal ileus tube in malignant adhesive bowel obstruction: A retrospective study

“…As a result of a poor nutritional status and the multilevel obstructions found in malignant adhesive obstructive bowel patients, treatment is more complicated. Only 30-48.9% of the patients have been successfully treated, as mentioned in the literature (17)(18)(19).…”