Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction
1 other identifier
interventional
200
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 20, 2015
November 1, 2015
3 years
November 18, 2013
November 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Stoma rates
From date of randomization until the follow-up ended, assessed up to 2 years
Mortality
From date of randomization until the date of death from any cause, assessed up to 2 years
Procedure related complication
From date of randomization until the first follow-up ended, assessed up to 30 days
Re-operation rates
From date of randomization until the follow-up ended, assessed up to 2 years
R0 resection
From date of randomization until the first follow-up ended, assessed up to 30 days
- +3 more secondary outcomes
Other Outcomes (2)
Technical success
From date of randomization until the first follow-up ended, assessed up to 30 days
Clinical success
From date of randomization until the first follow-up ended, assessed up to 30 days
Study Arms (2)
Colonic Stenting with Elective Surgery
EXPERIMENTALIn the experimental group, the patients will undergo colonic stenting within 24 h of inclusion. For this study, the WallFlex â„¢ 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.
Emergency Surgery
ACTIVE COMPARATORIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Above 18 years of age.
- Symptoms of colonic obstruction, existing less than one week.
- Malignant obstruction in the colon.
- Signed informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
Guangdong Province Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
Xiangya hospital central-south university
Changsha, Hunan, 410008, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Renji Hospital, Medical College of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200032, China
Related Publications (5)
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.
PMID: 21398178BACKGROUNDPirlet 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.
PMID: 21170659BACKGROUNDGhazal 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.
PMID: 23358847BACKGROUNDCheung 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.
PMID: 20026830BACKGROUNDAlcantara 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.
PMID: 21559998BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Side Liu, M.D.
Department of Gastroenterology, Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 28, 2013
Study Start
July 1, 2013
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
November 20, 2015
Record last verified: 2015-11