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

NCT ID: NCT03125148

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-27
• Study Completion Date: 2019-11-15

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Enteral stenting

Intervention Type: DEVICE

Enteral stent for malignant duodenal obstruction

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

Group Type: EXPERIMENTAL

Enteral stenting

Intervention Type: DEVICE

Enteral stent for malignant duodenal obstruction

Interventions

Enteral stenting

Enteral stent for malignant duodenal obstruction

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Kulwinder Dua, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Rusch, PhD

Role: STUDY_CHAIR

Medical College of Wisconsin

Locations

Froedtert Hospital

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO00028657

Identifier Type: -

Identifier Source: org_study_id