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

NCT03125148 | Completed Results FDA Device

• 1 other identifier: PRO00028657
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Duodenal Obstruction

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Day of stent deployment

• Complications

  Up to 6 months after stent deployment

• Gastric Emptying

  48 hours after stent placement

Study Arms (2)

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.

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

Device: Enteral stenting

Interventions

Enteral stenting DEVICE

Enteral stent for malignant duodenal obstruction

Enteral stenting intraduodenal; Enteral stenting transpyloric

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of cancer
• \. Evidence of a single small bowel obstruction
• \. Considered palliative (can be on narcotics, chemotherapy, and/or radiation therapy)
• \. Not a surgical candidate
• \. \>18 years of age
• \. Able to give consent
• \. Eligible for endoscopy (medically fit)
• \. Able to traverse past obstruction with a guidewire

You may not qualify if:

• \<18 years of age
• \. Unable to give consent
• \. Pregnant
• \. Have evidence of multiple sites of obstruction in the small bowel
• \. Have evidence of duodenal obstruction secondary to gastric cancer
• \. Ineligible for endoscopy (due to comorbidities or acuity of illness)
• \. Unable to traverse past obstruction with a guidewire

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Duodenal Obstruction

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Obstruction

Results Point of Contact

• Title: Kulwinder Dua, MD
• Organization: Medical College of Wisconsin

kdua@mcw.edu

4149556896

Study Officials

• Mark Rusch, PhD

  Medical College of Wisconsin

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: May 27, 2017
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: May 27, 2022
• Results First Posted: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)