Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction

Study Overview
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Brief Summary
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The use of colonic stenting with elective surgery has been suggested as an alternative management for acute malignant colonic obstruction, as emergency surgery has a high risk of morbidity and mortality. However, the available body of literature addressing their benefit in this setting is contradictory. The purpose of this study is to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.

Detailed Description
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Colorectal cancer is one commonly diagnosed malignancy worldwide, with an estimated 10 million new cases and 6 million deaths . Around 8%-29% of patients with colorectal cancer present with acute colonic obstruction, and 70% of all malignant obstruction occurs in the left-sided colon. It has been reported that about 15%-20 % of patients with colorectal cancer present with acute obstructive symptoms at the time of diagnosis. Conventionally, these patients are treated with emergency surgery to restore luminal continuity, which includes a variety of strategies such as the so-called two-stage surgery involving primary resection with colostomy (i.e., Hartmann's procedure) or proximal colostomy followed by resection, and one-stage surgery involving primary resection with anastomosis. Whatever the strategy chosen, the emergency surgery has an associated high risk of morbidity and mortality, and about two-thirds of such patients end up with a permanent stoma, which caused lower health-related quality of life and costs associated with stoma care. Since 1991, the colonic stenting has been applied as palliative treatment for patients with unresectable colorectal cancer. In 1993, Tejero et al. reported using colonic stenting as a bridge to definitive surgery. Recently, Zhang et al. conducted a meta-analysis of 8 studies (6 retrospective and 2 randomized trials) and indicated that stent placement before elective surgery, also known as a bridge to surgery, lead to a reduction in need of intensive care (risk ratio [RR], 0.42; 95% confidence interval, 0.19-0.93), stoma creation (RR, 0.70; 0.50-0.99), and overall complications (RR, 0.42; 0.24-0.71) compared with the emergency surgery cohort, meanwhile, colonic stenting with elective surgery achieved higher primary anastomosis rate (RR, 1.62; 1.21-2.16), and did not adversely affect the mortality and long-term survival. The most common complications of colonic stenting were re-obstruction (12%), migration (11%), and perforation (4.5%). However, the available body of literature addressing the benefit of colonic stenting with elective surgery is contradictory, and limited by the lack of the prospective randomised controlled trials. Therefore, we plan to conduct this multicenter, prospective, open label,cohort study, to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.

Official Title
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Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction: a Multicentre, Prospective, Open Label, Cohort Study

Conditions
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Acute Malignant Colonic Obstruction, Colorectal Cancer, Colonic Obstruction

Intervention / Treatment
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* Procedure: Colonic Stenting with Elective Surgery
* Procedure: Emergency Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above 18 years of age. Symptoms of colonic obstruction, existing less than one week. Malignant obstruction in the colon. Signed informed consent. Exclusion Criteria: Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk. Patients with signs of peritonitis, perforation, sepsis, or other serious complications demanding emergency surgery. Patients with distal rectal cancer less than 8 cm from the anal verge. Patients with suspected or proven metastatic adenocarcinoma. Patients with unresectable colorectal cancer, or planning for palliative treatment. Previous colonic surgery. Pregnancy or lactation women, or ready to pregnant women. Not capable of filling out questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonic Stenting with Elective Surgery<br>In the experimental group, the patients will undergo colonic stenting within 24 h of inclusion. For this study, the WallFlex ™ Colonic Stent (Boston Scientific, Natick, MA) will be employed. Candidates for elective surgery, after clinical success of colonic stenting, will be preferably operated on 5-14 days after inclusion, and no later than 4 weeks. Type and extent of the elective surgery will be selected by the surgeon. In this group, unplanned emergency surgery will be indicated in case of technical failure of colonic stenting, iatrogenic morbidity, or clinical failure. In case of a primary colostomy, restoration of bowel continuity was attempted within 3-6 months. | Procedure: Colonic Stenting with Elective Surgery<br>* After preparation of the distal colon with an enema, the colonoscope will be introduced up to the site of the obstruction. The colonic stent will be placed along a guide wire through the lesion under radiologic or endoscopic guidance. A colonic stent will be chosen which was at least 3 cm longer than the lesion (1.5 cm at either end). When the colonic stent did not cover the entire length of the lesion, a second overlapping stent will be placed. If the colonic stenting failed (technical failure) or symptoms of colonic obstruction did not resolve within 3 days (clinical failure), patients were indicated for emergency surgery. Candidates for elective surgery were preferably operated on 5-14 days after colonic stenting, and no later than 4 weeks. Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.<br>* Other names: Preoperative colonic stenting;|
| Active Comparator: Emergency Surgery<br>In the comparator group, patients will be undergo emergency surgery. Surgical options including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis. In case of a primary colostomy, restoration of bowel continuity was attempted within 3-6 months. | Procedure: Emergency Surgery<br>* Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of primary colorectal anastomosis | The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis by whatever elective or emergency surgery. | From date of randomization until the first follow-up ended, assessed up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stoma rates | The stoma constructed for any reason, whether temporary or definitive. | From date of randomization until the follow-up ended, assessed up to 2 years | 
| Mortality | Death from any cause. | From date of randomization until the date of death from any cause, assessed up to 2 years | 
| Procedure related complication | Including but not limited to: anastomotic leakage, wound infection, intra-abdominal sepsis, re-obstruction, stent migration, perforation, bleeding, etc. | From date of randomization until the first follow-up ended, assessed up to 30 days | 
| Re-operation rates | Re-operation is defined as repeat surgery or endoscopic treatment for whatever reason within 2 years. | From date of randomization until the follow-up ended, assessed up to 2 years | 
| R0 resection | R0 resection is defined as negative resection margins and no residual tumor. | From date of randomization until the first follow-up ended, assessed up to 30 days | 
| Quality of life | Quality of life assessments will be done with the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire,EORTC QLQ-C30, and the questionnaire module for colorectal cancer, EORTC QLQ-CR29. | From date of randomization until the follow-up ended, assessed up to 2 years | 
| Hospital stay and cost |  | From date of the admission to discharge, assessed up to 30 days | 
| Recurrence of colorectal cancer |  | From date of randomization until the follow-up ended, assessed up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Colonic Obstruction