N/A N=17 Randomized Treatment

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

Duodenal Obstruction

Bottom Line

View on ClinicalTrials.gov: NCT03125148 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline — 7; 6 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Enteral stenting (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical College of Wisconsin
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline	7; 6	—
SECONDARY Technical Success: Stent Placed in the Desired Position as Per Randomization	9; 8	—
SECONDARY Complications	0; 0	—
SECONDARY Gastric Emptying	5; 2	—

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.

Eligibility Criteria

Inclusion Criteria

1 - 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

Exclusion Criteria

1 - <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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03125148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.