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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
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.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGFujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGGuangdong Province Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGGuangzhou First People's Hospital
Guangzhou, Guangdong, China
RECRUITINGNanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGThe Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGXiangya hospital central-south university
Changsha, Hunan, China
RECRUITINGShengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGRenji Hospital, Medical College of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
RECRUITINGRates 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.
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
Stoma rates
The stoma constructed for any reason, whether temporary or definitive.
Time frame: From date of randomization until the follow-up ended, assessed up to 2 years
Mortality
Death from any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From date of randomization until the follow-up ended, assessed up to 2 years
Hospital stay and cost
Time frame: From date of the admission to discharge, assessed up to 30 days
Recurrence of colorectal cancer
Time frame: From date of randomization until the follow-up ended, assessed up to 2 years
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