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OpenTrials
Completed

NCT Number: NCT03125148

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral stenting

Device

Enteral stent for malignant duodenal obstruction

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Complications

    Time frame: Up to 6 months after stent deployment

    Stent related complications

  3. Gastric Emptying

    Time frame: 48 hours after stent placement

    Gastric emptying study test

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2017
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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