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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Duodenal Obstruction

Intervention / Treatment
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* Device: Enteral stenting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enteral stenting intraduodenal<br>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<br>* Enteral stent for malignant duodenal obstruction<br>|
| Experimental: Enteral stenting transpyloric<br>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<br>* Enteral stent for malignant duodenal obstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success: Stent Placed in the Desired Position as Per Randomization | 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 | Stent related complications | Up to 6 months after stent deployment | 
| Gastric Emptying | Gastric emptying study test | 48 hours after stent placement |