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

May 25, 2022 updated by: Kulwinder Dua, MD, Medical College of Wisconsin
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Enteral stenting
Enteral stent for malignant duodenal obstruction
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
Device: Enteral stenting
Enteral stent for malignant duodenal obstruction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Complications
Time Frame: Up to 6 months after stent deployment
Stent related complications
Up to 6 months after stent deployment
Gastric Emptying
Time Frame: 48 hours after stent placement
Gastric emptying study test
48 hours after stent placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mark Rusch, PhD, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00028657

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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