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

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ClinicalTrials.gov Identifier: NCT00140868
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : December 10, 2007
Sponsor:
Information provided by:
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Large Bowel Obstruction Device: Luminal stents Procedure: Minimally Invasive Surgical Bowel Diversion Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Outcome of Palliative Management of Malignant Large Bowel Obstruction With Colorectal Stents or Surgery
Study Start Date : December 2002
Actual Study Completion Date : October 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140868


Locations
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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
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Principal Investigator: Hans Gerdes, M.D. Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00140868    
Other Study ID Numbers: 02-125
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: December 10, 2007
Last Verified: December 2007
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:
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Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers