Duodenal Obstruction
Conditions
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.
Detailed description
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.
Interventions
DEVICEEnteral stenting
Enteral stent for malignant duodenal obstruction
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Technical Success: Stent Placed in the Desired Position as Per Randomization | 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. |
| Complications | Up to 6 months after stent deployment | Stent related complications |
| Gastric Emptying | 48 hours after stent placement | Gastric emptying study test |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enteral Stenting Intraduodenal 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 | 9 |
| Enteral Stenting Transpyloric 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 | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Enteral Stenting Transpyloric | Total | Enteral Stenting Intraduodenal |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 11 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 8 participants | 17 participants | 9 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 |
Outcome results
Primary
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.
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enteral Stenting Intraduodenal | Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline | 7 Participants |
| Enteral Stenting Transpyloric | Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline | 6 Participants |
Secondary
Complications
Stent related complications
Time frame: Up to 6 months after stent deployment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enteral Stenting Intraduodenal | Complications | 0 Participants |
| Enteral Stenting Transpyloric | Complications | 0 Participants |
Secondary
Gastric Emptying
Gastric emptying study test
Time frame: 48 hours after stent placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enteral Stenting Intraduodenal | Gastric Emptying | 5 Participants |
| Enteral Stenting Transpyloric | Gastric Emptying | 2 Participants |
Secondary
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.
Time frame: Day of stent deployment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enteral Stenting Intraduodenal | Technical Success: Stent Placed in the Desired Position as Per Randomization | 9 Participants |
| Enteral Stenting Transpyloric | Technical Success: Stent Placed in the Desired Position as Per Randomization | 8 Participants |