- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125148
Comparison of Duodenal Stenting vs Transpyloric and Duodenal Stenting for Malignant Obstruction
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1 - Confirmed diagnosis of cancer
2. Evidence of a single small bowel obstruction
3. Considered palliative (can be on narcotics, chemotherapy, and/or radiation therapy)
4. Not a surgical candidate
5. >18 years of age
6. Able to give consent
7. Eligible for endoscopy (medically fit)
8. Able to traverse past obstruction with a guidewire
Exclusion Criteria:
1 - <18 years of age
2. Unable to give consent
3. Pregnant
4. Have evidence of multiple sites of obstruction in the small bowel
5. Have evidence of duodenal obstruction secondary to gastric cancer
6. Ineligible for endoscopy (due to comorbidities or acuity of illness)
7. Unable to traverse past obstruction with a guidewire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Enteral stenting intraduodenal
Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction.
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Enteral stent for malignant duodenal obstruction
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Experimental: Enteral stenting transpyloric
Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the stent bridging the obstruction and the pyloric opening with proximal end of the stent lying within the stomach
|
Enteral stent for malignant duodenal obstruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline
Time Frame: Baseline (before stent) and follow-up (after stent) at 48 hrs (including gastric emptying study) and then symptom follow up at each clinic/telephone visit up to 6 months.
|
Symptoms of nausea, regurgitation, bloating, fullness, belching, pain, and vomiting were recorded at baseline and then on follow-up after stent placement on a visual analog scale with 0 being no symptoms and 10 being severe symptoms. The visual analog scale used was: 0 No symptom to 10 Severe symptom: Drop by 2 points or more from baseline score after intervention was recorded as "Better" and increase in over 2 points from baseline after intervention was recorded as symptom getting "Worse". A -1 to +1 shift from baseline was considered as "Unchanged". Gastric emptying was objectively assessed at 48 hours after stent placement with no baseline testing. Over all quality of life change after stent placement over baseline was a subjective response from the patient as being "Satisfied", "Neutral", "Dissatisfied." Re-interventions and adverse events if any were recorded. |
Baseline (before stent) and follow-up (after stent) at 48 hrs (including gastric emptying study) and then symptom follow up at each clinic/telephone visit up to 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical Success: Stent Placed in the Desired Position as Per Randomization
Time Frame: Day of stent deployment
|
Successful placement of the stent across the duodenal obstruction with or without trans-pyloric extension as per randomization will determined immediately during endoscopic procedure by endoscopic visualization.
|
Day of stent deployment
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Complications
Time Frame: Up to 6 months after stent deployment
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Stent related complications
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Up to 6 months after stent deployment
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Gastric Emptying
Time Frame: 48 hours after stent placement
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Gastric emptying study test
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48 hours after stent placement
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mark Rusch, PhD, Medical College Of Wisconsin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00028657
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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