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


Phase 3
18 Years
N/A
Not Enrolling
Both
Large Bowel Obstruction

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

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.

Principal Investigator

Hans Gerdes, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

02-125

NCT ID:

NCT00140868

Start Date:

December 2002

Completion Date:

October 2006

Related Keywords:

  • Large Bowel Obstruction
  • Colonic Pseudo-Obstruction
  • Large bowel obstruction
  • Stents
  • Laparotomy
  • Palliative Surgery
  • Surgery, Palliative
  • Palliative Therapy
  • Intestinal Obstruction

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021