Trial Outcomes & Findings for Comparison of Duodenal Stenting vs Transpyloric and Duodenal Stenting for Malignant Obstruction (NCT NCT03125148)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

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.

Results posted on

2022-05-27

Participant Flow

Participant milestones

Participant milestones
Measure	Enteral Stenting Intraduodenal GROUP A: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction. Enteral stenting: Enteral stent for malignant duodenal obstruction	Enteral Stenting Transpyloric GROUP B: 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 Enteral stenting: Enteral stent for malignant duodenal obstruction
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enteral Stenting Intraduodenal n=9 Participants Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction. Enteral stenting: Enteral stent for malignant duodenal obstruction	Enteral Stenting Transpyloric n=8 Participants 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 Enteral stenting: Enteral stent for malignant duodenal obstruction	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=9 Participants	5 Participants n=8 Participants	11 Participants n=17 Participants
Age, Categorical >=65 years	3 Participants n=9 Participants	3 Participants n=8 Participants	6 Participants n=17 Participants
Sex: Female, Male Female	3 Participants n=9 Participants	3 Participants n=8 Participants	6 Participants n=17 Participants
Sex: Female, Male Male	6 Participants n=9 Participants	5 Participants n=8 Participants	11 Participants n=17 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	8 participants n=8 Participants	17 participants n=17 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enteral Stenting Intraduodenal n=9 Participants GROUP A: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction. Enteral stenting: Enteral stent for malignant duodenal obstruction	Enteral Stenting Transpyloric n=8 Participants GROUP B: 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 Enteral stenting: Enteral stent for malignant duodenal obstruction
Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enteral Stenting Intraduodenal n=9 Participants GROUP A: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction. Enteral stenting: Enteral stent for malignant duodenal obstruction	Enteral Stenting Transpyloric n=8 Participants GROUP B: 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 Enteral stenting: Enteral stent for malignant duodenal obstruction
Technical Success: Stent Placed in the Desired Position as Per Randomization	9 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 6 months after stent deployment

Stent related complications

Outcome measures

Outcome measures
Measure	Enteral Stenting Intraduodenal n=9 Participants GROUP A: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction. Enteral stenting: Enteral stent for malignant duodenal obstruction	Enteral Stenting Transpyloric n=8 Participants GROUP B: 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 Enteral stenting: Enteral stent for malignant duodenal obstruction
Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours after stent placement

Gastric emptying study test

Outcome measures

Outcome measures
Measure	Enteral Stenting Intraduodenal n=9 Participants GROUP A: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction. Enteral stenting: Enteral stent for malignant duodenal obstruction	Enteral Stenting Transpyloric n=8 Participants GROUP B: 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 Enteral stenting: Enteral stent for malignant duodenal obstruction
Gastric Emptying	5 Participants	2 Participants

Adverse Events

Enteral Stenting Intraduodenal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enteral Stenting Transpyloric

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kulwinder Dua, MD

Medical College of Wisconsin

Phone: 4149556896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place