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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01997684
• Other study ID #: ISR-ENDO-2013-001
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2013
• Last updated: November 18, 2015
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xiaobing Cui, M.D.
• Phone: +86 13631312723
• Email: xbing119[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Malignant Colonic Obstruction
• Colonic Obstruction
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Colonic Stenting with Elective Surgery
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.
• Emergency Surgery
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.

Locations

Country	Name	City	State
China	Xiangya hospital central-south university	Changsha	Hunan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	Guangdong Province Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Renji Hospital, Medical College of Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Boston Scientific Corporation

Country where clinical trial is conducted

China, 

References & Publications (5)

Alcántara M, Serra-Aracil X, Falcó J, Mora L, Bombardó 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. — View 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. — View 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. — View 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. — View 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. Erratum in: Lancet Oncol. 2011 May;12(5):418. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technical success	Technically success is defined as successful endoscopic placement of the stent in the correct position.	From date of randomization until the first follow-up ended, assessed up to 30 days	Yes
Other	Clinical success	Clinical success is defined as the resolution of obstructive symptoms and the production of flatus or stool within 3 days after colonic stenting.	From date of randomization until the first follow-up ended, assessed up to 30 days	Yes
Primary	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	No
Secondary	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	No
Secondary	Mortality	Death from any cause.	From date of randomization until the date of death from any cause, assessed up to 2 years	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Hospital stay and cost		From date of the admission to discharge, assessed up to 30 days	No
Secondary	Recurrence of colorectal cancer		From date of randomization until the follow-up ended, assessed up to 2 years	No

External Links

•   Homepage of Department of Gastroenterology, Nanfang Hospital, Southern Medical University
•   Homepage of Nanfang Hospital, Southern Medical University