Large Bowel ObstructionPhase 3NCT00140868
Outcome of Palliative Management of Malignant Large Bowel Obstruction w/Colorectal Stents or Surgery
A Phase 3 study testing Luminal stents and Minimally Invasive Surgical Bowel Diversion in people with Large Bowel Obstruction, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Bowel Obstruction
- What is being tested?
- Luminal stents and Minimally Invasive Surgical Bowel Diversion
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Oct 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Outcome of Palliative Management of Malignant Large Bowel Obstruction With Colorectal Stents or Surgery
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.
Read the 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.
- Conditions
- Large Bowel Obstruction
- Being tested
- Luminal stents, Minimally Invasive Surgical Bowel Diversion
- Keywords
- Colonic Pseudo-Obstruction, Large bowel obstruction, Stents, Laparotomy, Palliative Surgery, Surgery, Palliative, Palliative Therapy
- Medical subject headings
- Colonic Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminal stentsDevice
Minimally Invasive Surgical Bowel DiversionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startDec 2002
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Hans Gerdes, M.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140868
- Sponsor's protocol ID
- 02-125
- Status last verified
- Dec 2007
- First submitted
- 30 Aug 2005
- Last updated
- 10 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Palliative Management of Malignant Large Bowel Obstruction With Colorectal Stents or Surgery
- ClinicalTrials.gov ID
- NCT00140868
- Acronym / sponsor ID
- 02-125
- Conditions
- Large Bowel Obstruction
- Keywords
- Colonic Pseudo-Obstruction, Large bowel obstruction, Stents, Laparotomy, Palliative Surgery, Surgery, Palliative, Palliative Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2002
- Study completion
- Oct 2006 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luminal stents | Device | – |
| Minimally Invasive Surgical Bowel Diversion | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2007.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Gerdes, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Luminal stents and Minimally Invasive Surgical Bowel Diversion in people with Large Bowel Obstruction, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2007.