Acute Pancreatic Necrosis, Acute Pancreatitis, Necrotizing Pancreatitis
Conditions
Keywords
Direct Endoscopic Necrosectomy, Walled Off Necrosis, Walled Off Pancreatic Necrosis
Brief summary
A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off pancreatic necrosis (WOPN).
Detailed description
A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN). Total enrollment 30 subjects with at least 15 enrolled in the US. Subjects will be debrided with the EndoRotor either at the time of stent placement or post placement at Investigator's discretion with a maximum of 4 EndoRotor procedures. A minimum of 2 days is required between each EndoRotor procedure and all procedures need to be completed within a 14 (+7/-0) day period. Follow up is completed 21 (+/- 7) days after last EndoRotor debridement procedure.
Interventions
DEVICEEndoRotor Therapy
To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Sponsors
Interscope, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN).
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who are \>22; inclusive of males and females. 2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage 3. Imaging suggestive of greater than or equal to 30% necrotic material 4. Walled off pancreatic necrosis size ≥6 cm and ≤22cm 5. Subject can tolerate repeated endoscopic procedures 6. Subject capable of giving informed consent. 7. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7) days, as indicated.
Exclusion criteria
1. Subject unable to give informed consent. 2. Subject is unwilling to return for repeated endoscopies. 3. Documented Pseudoaneurysm \> 1cm within the WOPN 4. Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound). 5. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure 6. Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance). 7. Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation. 8. Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Participants With Device Related Complications | 21 +/- 7 Days | The primary endpoint of this study is the freedom from major device related complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis | Completion of all necrosectomy procedures per patient | Assessment of total procedure time to achieve clearance of necrosis for all procedures. Total procedure time is measured from scope-in to scope-out. EndoRotor time is measured from the start of EndoRotor use to the end of EndoRotor use. |
| Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure. | This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated. | At the completion of each necrosectomy procedure the Investigator will visually inspect the WOPN cavity endoscopically and estimate the percent of necrosis that was removed from the cavity using EndoRotor. For each procedure, the initial amount of necrosis in the WOPN cavity is considered 100%. |
| Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed | 21 +/- 7 Days | Successful clearance of necrosis in the collection being treated during direct endoscopic necrosectomy where success is defined as at least 70% of the necrotic debris in the collection being treated is removed based on CT evaluation of the cavity at the 21 (+/-7) day follow up visit. |
| Mean Length of Hospital Stay Per Participant | At patient discharge from hospital | The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge. |
| Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | 21 +/- 7 Days | The SF-36v1 questionnaire measures functional health and well-being from a patient's point of view. The questionnaire assess eight health domains including: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well Being, Social Functioning, Pain, and General Health. Participants were asked to complete the questionnaire at the Baseline Visit and then again at the 21 Day Post Necrosectomy Follow-up Visit. The results of the questionnaire from the 21 Day Post Necrosectomy Follow-up Visit were then compared to those of Baseline for improvement. Numeric scores for each health domain are reported on a scale of 0-100 with improvement demonstrated by a higher score than baseline. Statistically significant improvement is denoted by differences in Baseline and 21 Day Follow-up Visit scores that have a p-value \< 0.05. |
| Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis. | This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated. | The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed. |
Countries
Germany, Netherlands, United States
Participant flow
Recruitment details
Enrollment Dates: November 2018 to August 2019
Participants by arm
| Arm | Count |
|---|---|
| EndoRotor Therapy Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Screen Failure | 7 |
Baseline characteristics
| Characteristic | EndoRotor Therapy |
|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 15.5 |
| Cause of Pancreatitis Alcohol | 5 Participants |
| Cause of Pancreatitis Gallstone/biliary | 18 Participants |
| Cause of Pancreatitis Unknown Cause | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment Germany | 5 participants |
| Region of Enrollment Netherlands | 2 participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 11 / 30 |
| serious Total, serious adverse events | 9 / 30 |
Outcome results
Primary
Safety: Number of Participants With Device Related Complications
The primary endpoint of this study is the freedom from major device related complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding.
Time frame: 21 +/- 7 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoRotor Therapy | Safety: Number of Participants With Device Related Complications | 0 Participants |
Secondary
Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.
At the completion of each necrosectomy procedure the Investigator will visually inspect the WOPN cavity endoscopically and estimate the percent of necrosis that was removed from the cavity using EndoRotor. For each procedure, the initial amount of necrosis in the WOPN cavity is considered 100%.
Time frame: This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoRotor Therapy | Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure. | 60 % Necrosis removed for all procedures | Standard Deviation 33 |
Secondary
Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed
Successful clearance of necrosis in the collection being treated during direct endoscopic necrosectomy where success is defined as at least 70% of the necrotic debris in the collection being treated is removed based on CT evaluation of the cavity at the 21 (+/-7) day follow up visit.
Time frame: 21 +/- 7 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoRotor Therapy | Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed | 29 Participants |
Secondary
Mean Length of Hospital Stay Per Participant
The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge.
Time frame: At patient discharge from hospital
Population: Patients with outpatient visits were assigned 0.5 days conservatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoRotor Therapy | Mean Length of Hospital Stay Per Participant | 18 Days | Standard Deviation 25 |
Secondary
Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.
The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed.
Time frame: This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoRotor Therapy | Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis. | 2 Procedures | Standard Deviation 2 |
Secondary
Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis
Assessment of total procedure time to achieve clearance of necrosis for all procedures. Total procedure time is measured from scope-in to scope-out. EndoRotor time is measured from the start of EndoRotor use to the end of EndoRotor use.
Time frame: Completion of all necrosectomy procedures per patient
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoRotor Therapy | Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis | Total Procedure Time | 117 Minutes | Standard Deviation 50 |
| EndoRotor Therapy | Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis | EndoRotor Time | 71 Minutes | Standard Deviation 37 |
Secondary
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
The SF-36v1 questionnaire measures functional health and well-being from a patient's point of view. The questionnaire assess eight health domains including: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well Being, Social Functioning, Pain, and General Health. Participants were asked to complete the questionnaire at the Baseline Visit and then again at the 21 Day Post Necrosectomy Follow-up Visit. The results of the questionnaire from the 21 Day Post Necrosectomy Follow-up Visit were then compared to those of Baseline for improvement. Numeric scores for each health domain are reported on a scale of 0-100 with improvement demonstrated by a higher score than baseline. Statistically significant improvement is denoted by differences in Baseline and 21 Day Follow-up Visit scores that have a p-value \< 0.05.
Time frame: 21 +/- 7 Days
Population: All participants who had a completed SF-36v1 Questionnaire at both Baseline and the 21 Day Follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoRotor Therapy | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Physical Functioning | 36.0 score on a scale | Standard Deviation 30.8 |
| EndoRotor Therapy | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Role Limitations due to Physical Health | 11.4 score on a scale | Standard Deviation 28.5 |
| EndoRotor Therapy | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Role Limitations due to Emotional Problems | 27.8 score on a scale | Standard Deviation 41.3 |
| EndoRotor Therapy | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Energy / Fatigue | 27.9 score on a scale | Standard Deviation 22 |
| EndoRotor Therapy | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Emotional Well Being | 60.7 score on a scale | Standard Deviation 19.7 |
| EndoRotor Therapy | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Social Functioning | 51.6 score on a scale | Standard Deviation 32.6 |
| EndoRotor Therapy | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Pain | 31.4 score on a scale | Standard Deviation 28.4 |
| EndoRotor Therapy | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | General Health | 47.8 score on a scale | Standard Deviation 15.9 |
| 21 Day Post Necrosectomy SF-36v1 Score | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | General Health | 53.8 score on a scale | Standard Deviation 15.3 |
| 21 Day Post Necrosectomy SF-36v1 Score | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Physical Functioning | 57.3 score on a scale | Standard Deviation 30.8 |
| 21 Day Post Necrosectomy SF-36v1 Score | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Emotional Well Being | 68.3 score on a scale | Standard Deviation 18.9 |
| 21 Day Post Necrosectomy SF-36v1 Score | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Role Limitations due to Physical Health | 25.0 score on a scale | Standard Deviation 37.6 |
| 21 Day Post Necrosectomy SF-36v1 Score | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Pain | 56.0 score on a scale | Standard Deviation 30.1 |
| 21 Day Post Necrosectomy SF-36v1 Score | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Role Limitations due to Emotional Problems | 51.4 score on a scale | Standard Deviation 48.1 |
| 21 Day Post Necrosectomy SF-36v1 Score | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Social Functioning | 56.3 score on a scale | Standard Deviation 26.6 |
| 21 Day Post Necrosectomy SF-36v1 Score | Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | Energy / Fatigue | 36.7 score on a scale | Standard Deviation 23.2 |
Comparison: Physical Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.p-value: 0.0011Wilcoxon Signed Rank Test
Comparison: Role Limitations due to Physical Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.p-value: 0.1152Wilcoxon Signed Rank Test
Comparison: Role Limitations due to Emotional Problems: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.p-value: 0.0552Wilcoxon Signed Rank Test
Comparison: Energy/Fatigue: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.p-value: 0.039Wilcoxon Signed Rank Test
Comparison: Emotional Well Being: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.p-value: 0.0223Wilcoxon Signed Rank Test
Comparison: Social Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.p-value: 0.4664Wilcoxon Signed Rank Test
Comparison: Pain: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.p-value: 0.0001Wilcoxon Signed Rank Test
Comparison: General Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.p-value: 0.0639Wilcoxon Signed Rank Test