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

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

17

Phase

  • 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

    • 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

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
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.
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
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
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.

Investigators

  • 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)

May 27, 2017

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

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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