Duodenal ObstructionNCT03125148
Comparison of Duodenal Stenting vs Transpyloric and Duodenal Stenting for Malignant Obstruction
A study testing Enteral stenting in people with Duodenal Obstruction, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Obstruction
- What is being tested?
- Enteral stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2017to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Enteral self-expanding metal stents are routinely used to palliate malignant gastric outlet obstruction (pancreas cancer, duodenal cancer, gastric cancer and metastasis) in patients not fit for surgical bypass. The technical success in placing these stents approaches ~100% and many of these procedures can be performed in an outpatient setting. However the functional success (patient's ability to eat) is much lower than the technical success. One of the major reasons for this discrepancy is these patients are on narcotics, which are known to be associated with poor gastric motility. At the discretion of the gastroenterologist, FDA approved enteral stents are placed either completely within the duodenum bridging the obstruction or placed across the pyloric opening besides bridging the duodenal obstruction. The significance of this study is to determine if trans-pyloric extension of an intra-duodenal stent facilitates better gastric emptying compared to an intra-duodenal stent without trans-pyloric extension.
- Conditions
- Duodenal Obstruction
- Being tested
- Enteral stenting
- Medical subject headings
- Duodenal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral stentingDevice
Enteral stent for malignant duodenal obstruction
| Study group | Role | What they receive |
|---|---|---|
| Enteral stenting intraduodenal | Active comparator | Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction. Receives: Device: Enteral stenting |
| Enteral stenting transpyloric | Experimental | 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 Receives: Device: Enteral stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline
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.
Measured: 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 outcomes (3)
Technical Success: Stent Placed in the Desired Position as Per Randomization
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.
Measured: Day of stent deployment
Complications
Stent related complications
Measured: Up to 6 months after stent deployment
Gastric Emptying
Gastric emptying study test
Measured: 48 hours after stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start27 May 2017
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Duodenal ObstructionStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kulwinder Dua, MD, Medical College of Wisconsin
- Investigators
- Mark Rusch, PhD, Study chair, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125148
- Sponsor's protocol ID
- PRO00028657
- Status last verified
- May 2022
- First submitted
- 14 Apr 2017
- Last updated
- 27 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Duodenal Stenting vs Transpyloric and Duodenal Stenting for Malignant Obstruction
- ClinicalTrials.gov ID
- NCT03125148
- Acronym / sponsor ID
- PRO00028657
- Conditions
- Duodenal Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 27 May 2017 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 27 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Enteral self-expanding metal stents are routinely used to palliate malignant gastric outlet obstruction (pancreas cancer, duodenal cancer, gastric cancer and metastasis) in patients not fit for surgical bypass. The technical success in placing these stents approaches ~100% and many of these procedures can be performed in an outpatient setting. However the functional success (patient's ability to eat) is much lower than the technical success. One of the major reasons for this discrepancy is these patients are on narcotics, which are known to be associated with poor gastric motility. At the discretion of the gastroenterologist, FDA approved enteral stents are placed either completely within the duodenum bridging the obstruction or placed across the pyloric opening besides bridging the duodenal obstruction. The significance of this study is to determine if trans-pyloric extension of an intra-duodenal stent facilitates better gastric emptying compared to an intra-duodenal stent without trans-pyloric extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral stenting intraduodenal | Active comparator | Device: Enteral stentingEnteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction. |
| Enteral stenting transpyloric | Experimental | Device: Enteral stentingEnteral 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Enteral stentingEnteral stent for malignant duodenal obstruction | Device | Enteral stenting intraduodenal, Enteral stenting transpyloric |
Primary outcome
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.
3 secondary outcomes
Technical Success: Stent Placed in the Desired Position as Per Randomization
Time frame: Day of stent deployment
Complications
Time frame: Up to 6 months after stent deployment
Gastric Emptying
Time frame: 48 hours after stent placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mark Rusch, PhD study chair
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral stenting in people with Duodenal Obstruction, run by Medical College of Wisconsin 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 8 inclusion and 7 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 27 May 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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.). 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 27 May 2022.