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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Nanfang Hospital of Southern Medical University
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01997684
First received: November 18, 2013
Last updated: November 24, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Acute Malignant Colonic Obstruction
Colorectal Cancer
Colonic Obstruction
Procedure: Colonic Stenting with Elective Surgery
Procedure: Emergency Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction: a Multicentre, Prospective, Open Label, Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • Rates of primary colorectal anastomosis [ Time Frame: From date of randomization until the first follow-up ended, assessed up to 30 days ] [ Designated as safety issue: No ]
    The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis by whatever elective or emergency surgery.


Secondary Outcome Measures:
  • Stoma rates [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: No ]
    The stoma constructed for any reason, whether temporary or definitive.

  • Mortality [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 2 years ] [ Designated as safety issue: Yes ]
    Death from any cause.

  • Procedure related complication [ Time Frame: From date of randomization until the first follow-up ended, assessed up to 30 days ] [ Designated as safety issue: Yes ]
    Including but not limited to: anastomotic leakage, wound infection, intra-abdominal sepsis, re-obstruction, stent migration, perforation, bleeding, etc.

  • Re-operation rates [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: Yes ]
    Re-operation is defined as repeat surgery or endoscopic treatment for whatever reason within 2 years.

  • R0 resection [ Time Frame: From date of randomization until the first follow-up ended, assessed up to 30 days ] [ Designated as safety issue: No ]
    R0 resection is defined as negative resection margins and no residual tumor.

  • Quality of life [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Hospital stay and cost [ Time Frame: From date of the admission to discharge, assessed up to 30 days ] [ Designated as safety issue: No ]
  • Recurrence of colorectal cancer [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Technical success [ Time Frame: From date of randomization until the first follow-up ended, assessed up to 30 days ] [ Designated as safety issue: Yes ]
    Technically success is defined as successful endoscopic placement of the stent in the correct position.

  • Clinical success [ Time Frame: From date of randomization until the first follow-up ended, assessed up to 30 days ] [ Designated as safety issue: Yes ]
    Clinical success is defined as the resolution of obstructive symptoms and the production of flatus or stool within 3 days after colonic stenting.


Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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.

Other Names:
  • Colonic stenting as a bridge to elective surgery
  • Colonic stenting and elective surgery
  • Colonic stenting and deferred surgery
  • Preoperative colonic stenting
Active Comparator: 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.

Procedure: 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.

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, randomized control trial, to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 18 and 75 years of age.
  • Symptoms of colonic obstruction, existing less than one week.
  • Malignant obstruction in the left 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997684

Contacts
Contact: Xiaobing Cui, M.D. +86 13631312723 xbing119@gmail.com
Contact: Wei Gong, M.D. +86 15820290385 179346561@qq.com

Locations
China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Principal Investigator: Yonghui Huang, M.D.         
China, Fujian
Fujian Provincial Hospital Recruiting
Fuzhou, Fujian, China, 350001
Principal Investigator: Liping He, M.D.         
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
Principal Investigator: Fenglin Chen, M.D.         
China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Principal Investigator: Wei Gong, M.D.         
Guangdong Province Hospital of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Principal Investigator: Beiping Zhang, M.D.         
The Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Principal Investigator: Chujun Li, M.D.         
China, Hunan
Xiangya hospital central-south university Recruiting
Changsha, Hunan, China, 410008
Principal Investigator: Miao Ouyang, M.D.         
China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Principal Investigator: Siyu Sun, M.D.         
China, Shanghai
Renji Hospital, Medical College of Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200032
Principal Investigator: Ming Zhong, M.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Boston Scientific Corporation
Investigators
Study Chair: Bo Jiang, M.D. Department of Gastroenterology, Nanfang Hospital, Southern Medical University
  More Information

Additional Information:
Publications:

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01997684     History of Changes
Other Study ID Numbers: ISR-ENDO-2013-001
Study First Received: November 18, 2013
Last Updated: November 24, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanfang Hospital of Southern Medical University:
Colorectal Cancer
Colonic Obstruction

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Emergencies
Intestinal Obstruction
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014