Outcome of Palliative Management of Malignant Large Bowel Obstruction w/Colorectal Stents or Surgery

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00140868
First received: August 30, 2005
Last updated: December 6, 2007
Last verified: December 2007
  Purpose

The purpose of this study is to assess quality of life and bowel symptoms after treatment.The main objective is to compare the effect on quality of life of minimally invasive bowel surgery and endoscopic stent placement in the treatment of malignant large bowel obstruction.


Condition Intervention Phase
Large Bowel Obstruction
Device: Luminal stents
Procedure: Minimally Invasive Surgical Bowel Diversion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Outcome of Palliative Management of Malignant Large Bowel Obstruction With Colorectal Stents or Surgery

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Primary objective: compare the effect on quality of life of minimally invasive surgical bowel diversion and endoscopic stent placement in the treatment of malignant large bowel obstruction.

Secondary Outcome Measures:
  • Secondary objectives:the symptom response and complication rate of treatment of malignant large bowel obstruction with endoscopic stent placement or minimally invasive surgical bowel diversion

Estimated Enrollment: 180
Study Start Date: December 2002
Study Completion Date: October 2006
Detailed Description:

Large bowel obstruction is a common presentation among cancer patients, including those with non-colorectal malignancies. This study will evaluate patients with malignant large bowel obstruction who undergo palliative treatment with minimally invasive surgical diversion or endoscopic colorectal stent placement, in terms quality of life, symptom relief from bowel obstruction, and treatment-related complications. Assessments in changes in quality of life and symptom relief over time for each group will be done.

Traditionally malignant bowel obstruction is treated with surgery. In the last decade, creation of an ostomy can be completed with minimally invasive surgery, which reduces morbidity, mortality, and recovery time.wishes.

In the last several years, endoscopically inserted colorectal stents have emerged as an option for palliative treatment. This involves a simple procedure, often completed on an outpatient basis. This allows the intestinal lumen to remain open without the need for surgery.

  • Primary Objective: is to compare the effect on quality of life of minimally invasive surgical bowel diversion and endoscopic stent placement in the treatment of malignant large bowel obstruction.
  • Secondary Objectives: are to evaluate the symptom response (including abdominal pain, distention, bowel frequency and consistency, and nausea and emesis) and complication rate of treatment of malignant large bowel obstruction with endoscopic stent placement or minimally invasive surgical bowel diversion.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women over 18 years of age
  • presentation of large bowel obstruction based on clinical symptoms AND an imaging study.
  • clinical symptoms: one of : progressive constipation, multiple small liquid bowel movements daily, abdominal distention, abdominal pain or nausea and vomiting.
  • imaging study: one of: CT scan, barium or gastrograffin enema, flexible sigmoidoscopy or colonoscopy, showing any degree of colonic narrowing by tumor.
  • large bowel obstruction due to stage IV colorectal cancer unresectable for cure OR unresectable local-regional colorectal cancer OR unresectable extra-colonic cancer (such as gastric, ovarian, prostate, pancreatic cancers).
  • ability to give informed consent, indicating the investigational nature of this study in keeping with the policies of Memorial Sloan-Kettering Cancer Center.

Exclusion Criteria:

  • presence of acute bowel perforation
  • presence of a second synchronous large or small bowel obstruction site
  • contra-indication to stent placement:
  • obstruction greater than 12 cm in length (ie precluding treatment with one stent)
  • obstruction located within 2 cm of dentate line
  • contra-indication to laparoscopy:
  • presence of MI, unstable angina, or CVA in the previous four weeks
  • tense ascites
  • uncorrectable coagulopathy
  • prior abdominal surgery with known prohibitive adhesions
  • prior PALLIATIVE treatment of malignant large bowel obstruction with surgery or stent
  • inability to speak or read English, or other impairment which causes an inability to complete the quality of life questionnaires
  • unable or unwilling to give informed consent
  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: NCT00140868

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Hans Gerdes, M.D. Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00140868     History of Changes
Other Study ID Numbers: 02-125
Study First Received: August 30, 2005
Last Updated: December 6, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Colonic Pseudo-Obstruction
Large bowel obstruction
Stents
Laparotomy
Palliative Surgery
Surgery, Palliative
Palliative Therapy

Additional relevant MeSH terms:
Intestinal Obstruction
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 21, 2014