CompletedNot Applicable

Comparison of Duodenal Stenting vs Transpyloric and Duodenal Stenting for Malignant Obstruction

United States17 participantsStarted 2017-05-27

Plain-language summary

Malignant duodenal obstruction in patients not fit for surgery is treated by placing enteral stents during endoscopy. These patients may also have poor gastric motility. Hence bridging the pyloric opening with the stent along with the duodenal obstruction may deliver better symptomatic improvement. Both approaches are commonly clinically practiced but no formal comparative studies have been done to compare which one is better.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline

Timeframe: 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.

Trial details

NCT IDNCT03125148

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-15

Results submitted2021-05-06

View on ClinicalTrials.gov More Duodenal Obstruction trials