Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction
NCT ID: NCT01997684
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2013-07-31
2016-12-31
Brief Summary
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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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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Colonic Stenting with Elective Surgery
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.
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
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptoms of colonic obstruction, existing less than one week.
* Malignant obstruction in the colon.
* Signed informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Side Liu, M.D.
Role: STUDY_CHAIR
Department of Gastroenterology, Nanfang Hospital, Southern Medical University
Locations
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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
Xiangya hospital central-south university
Changsha, Hunan, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Renji Hospital, Medical College of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hong Wang, M.D.
Role: primary
References
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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.
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.
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.
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.
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.
Related Links
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Homepage of Nanfang Hospital, Southern Medical University
Homepage of Department of Gastroenterology, Nanfang Hospital, Southern Medical University
Other Identifiers
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ISR-ENDO-2013-001
Identifier Type: -
Identifier Source: org_study_id