Clinical trial NCT01997684: Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction
Official title: Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction: a Multicentre, Prospective, Open Label, Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Malignant Colonic Obstruction
Colorectal Cancer
Colonic Obstruction
Keywords: Colorectal Cancer
Colonic Obstruction
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2013-11-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rates of primary colorectal anastomosis
timeFrame: From date of randomization until the first follow-up ended, assessed up to 30 days
Secondary outcomes:
measure: Stoma rates
timeFrame: From date of randomization until the follow-up ended, assessed up to 2 years
measure: Mortality
timeFrame: From date of randomization until the date of death from any cause, assessed up to 2 years
measure: Procedure related complication
timeFrame: From date of randomization until the first follow-up ended, assessed up to 30 days
measure: Re-operation rates
timeFrame: From date of randomization until the follow-up ended, assessed up to 2 years
measure: R0 resection
timeFrame: From date of randomization until the first follow-up ended, assessed up to 30 days
measure: Quality of life
timeFrame: From date of randomization until the follow-up ended, assessed up to 2 years
measure: Hospital stay and cost
timeFrame: From date of the admission to discharge, assessed up to 30 days
measure: Recurrence of colorectal cancer
timeFrame: From date of randomization until the follow-up ended, assessed up to 2 years
Other outcomes:
measure: Technical success
timeFrame: From date of randomization until the first follow-up ended, assessed up to 30 days
measure: Clinical success
timeFrame: From date of randomization until the first follow-up ended, assessed up to 30 days
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Changsha
country: China
facility: Xiangya hospital central-south university
state: Hunan
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Renji Hospital, Medical College of Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Department of Gastroenterology, Nanfang Hospital, Southern Medical University
name: Side Liu, M.D.
role: STUDY_CHAIR
References:
citation: van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P; collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol. 2011 Apr;12(4):344-52. doi: 10.1016/S1470-2045(11)70035-3.
citation: Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.
citation: Ghazal AH, El-Shazly WG, Bessa SS, El-Riwini MT, Hussein AM. Colonic endolumenal stenting devices and elective surgery versus emergency subtotal/total colectomy in the management of malignant obstructed left colon carcinoma. J Gastrointest Surg. 2013 Jun;17(6):1123-9. doi: 10.1007/s11605-013-2152-2. Epub 2013 Jan 29.
citation: Cheung HY, Chung CC, Tsang WW, Wong JC, Yau KK, Li MK. Endolaparoscopic approach vs conventional open surgery in the treatment of obstructing left-sided colon cancer: a randomized controlled trial. Arch Surg. 2009 Dec;144(12):1127-32. doi: 10.1001/archsurg.2009.216.
citation: Alcantara M, Serra-Aracil X, Falco J, Mora L, Bombardo J, Navarro S. Prospective, controlled, randomized study of intraoperative colonic lavage versus stent placement in obstructive left-sided colonic cancer. World J Surg. 2011 Aug;35(8):1904-10. doi: 10.1007/s00268-011-1139-y.