Status:
COMPLETED
Outcome of Palliative Management of Malignant Large Bowel Obstruction w/Colorectal Stents or Surgery
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Large Bowel Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 endosco...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00140868
Start Date
December 1 2002
End Date
October 1 2006
Last Update
December 10 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021