Pancreatic Pseudocyst
Conditions
Keywords
Endoscopic ultrasound guided transluminal drainage
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of endoscopic ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of pancreatic pseudocyst.
Detailed description
'Niti-S SPAXUS Stent' is a newly designed lumen-apposing fully covered self-expandable metal stent. It is indicated for use in patients with pancreatic pseudocyst. Consecutive subject data should be collected at discharge, stent removal (day 30 or 60), and day 20 post Niti-S SPAXUS stent removal.
Interventions
DEVICENiti-S SPAXUS Stent
Endoscopic Ultrasound-Guided Transluminal drainage
Sponsors
Taewoong Medical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The investigational device (ID) 'Niti-S SPAXUS Stent' is used for drainage of cystic fluid by being connected to the pancreatic pseudocyst through human organs such as stomach or duodenum. It is composed with a stent made of nitinol and introducer system.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pancreatic pseudocyst ≥6cm in size, with ≥70% fluid content that is eligible for transluminal drainage * Patient willing to provide written informed consent and comply with follow-up requirements
Exclusion criteria
* Ineligible for endoscopic intervention * Pancreatic pseudocyst with severe internal septation * Platelet count \< 60,000 cells/mm3 or international normalized ratio (INR) \>1.5 * Hemodynamic instability (e.g. shock) * Active infectious disease (e.g. endocarditis, meningitis) * Participating in any other investigational drug or device clinical trial within past 3 months * Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success | at stent removal (Day 30 or Day 60) | Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stent Lumen Patency | up to 60 days (at stent removal, Day 30 or 60) | Stent lumen patency will be evaluated by endoscopy. |
| Number of Participants With Stent Removal Success | up to 60 days (at stent removal, Day 30 or 60) | Stent removal success is defined as successful removal of the Niti-S SPAXUS stent using a standard endoscopic forceps or snare. |
| Number of Participants With Technical Success | Day 1 | Technical success is defined as successful placement of the Niti-S SPAXUS stent across the gastric(or duodenal) wall to the pseudocyst with visualization of the pseudocyst fluid drainage through the stent by endoscopy. |
| Number of Participants With Procedural/Device Related Serious Adverse Events | up to 90 days (at Day 20 post stent removal) | The incidence of serious adverse events related to the procedure or the Niti-S SPAXUSTM stent is assessed at Day 20 after the stent removal |
| Other Adverse Events | up to 90 days (at Day 20 post stent removal) | The severity and incidence of all other adverse events than those mentioned above occurred during the follow-up period were evaluated at Day 20 day after the stent removal. |
| Procedure Time | 1 day | Procedure time is measured as time from insertion until removal of endoscope. Procedure time 1: The time from the moment that the endoscope is inserted into the oral cavity to the time point at which the endoscope is removed. (sec) Procedure time 2: The time from the puncture time to the point at which the ultrasound endoscope was removed. (sec) |
Countries
South Korea
Participant flow
Recruitment details
It took about 15 months from the approval of the Ministry of Food and Drug Safety(MFDS) and the IRB, including the subject enrollment period of about 13 months and the follow-up period of 2 months at maximum.
Participants by arm
| Arm | Count |
|---|---|
| Niti-S SPAXUS Stent Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)
Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Niti-S SPAXUS Stent | — |
|---|---|---|
| Age, Continuous | 52.51 years STANDARD_DEVIATION 13.22 | — |
| Alcohol drinking Current Drinker | 13 participants | — |
| Alcohol drinking Ex-Drinker | 14 participants | — |
| Alcohol drinking Non-Drinker | 8 participants | — |
| Body weight | 64.34 kg | — |
| Height | 167.82 cm | — |
| History of allergy No | 33 participants | — |
| History of allergy Yes | 2 participants | — |
| History of smoking Current Smoker | 13 participants | — |
| History of smoking Ex-Smoker | 10 participants | — |
| History of smoking Non-Smoker | 12 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment South Korea | 35 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 27 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 29 / 35 |
| serious Total, serious adverse events | 14 / 35 |
Outcome results
Primary
Number of Participants With Clinical Success
Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)
Time frame: at stent removal (Day 30 or Day 60)
Population: The analysis is performed in the subjects who underwent the Niti-S SPAXUS stent and have the results of effectiveness assessment at the time point of the stent removal among those who satisfy the inclusion • exclusion criteria, consented to participate in the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Niti-S SPAXUS Stent | Number of Participants With Clinical Success | 33 participants |
Comparison: The clinical success rate at the time point of stent removal is reported 86.2% according to the approval data of the commercially available AXIOS stent submitted to the US FDA. The clinical success rates of EUS-guided transluminal drainage using a lumen-appending stent were 93.3% (29 cases), 100% (8 cases) and 100% (7 cases) respectively in the studies performed afterwards by Shah RJ (2015), Gornals JB (2012) and Moon JH (2014). The weighted average calculated for each study was about 96%.p-value: 0.05t-test, 2 sided
Secondary
Number of Participants With Procedural/Device Related Serious Adverse Events
The incidence of serious adverse events related to the procedure or the Niti-S SPAXUSTM stent is assessed at Day 20 after the stent removal
Time frame: up to 90 days (at Day 20 post stent removal)
Population: * Resulted in death or life threatening~ * Required inpatient hospitalization or prolongation of existing hospitalization ③ Resulted in persistent or significant disability/incapacity ④ Caused a congenital anomaly/birth defect
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Niti-S SPAXUS Stent | Number of Participants With Procedural/Device Related Serious Adverse Events | 14 participants |
Secondary
Number of Participants With Stent Lumen Patency
Stent lumen patency will be evaluated by endoscopy.
Time frame: up to 60 days (at stent removal, Day 30 or 60)
Population: The stent lumen patency will be evaluated by the investigator at Day 30 or 60 (± 10 days) after the procedure of the Niti-S SPAXUS stent through clinical symptoms and endoscopy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Niti-S SPAXUS Stent | Number of Participants With Stent Lumen Patency | 34 Participants |
Secondary
Number of Participants With Stent Removal Success
Stent removal success is defined as successful removal of the Niti-S SPAXUS stent using a standard endoscopic forceps or snare.
Time frame: up to 60 days (at stent removal, Day 30 or 60)
Population: When the Niti-S SPAXUSTM Stent is successfully removed by using forceps or snare through endoscopy as the treatment is succeeded clinically at Day 30 or 60 (± 10 days) according to standard procedures and the criteria for stent removal are met, it is considered as the stent removal success.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Niti-S SPAXUS Stent | Number of Participants With Stent Removal Success | 34 Participants |
Secondary
Number of Participants With Technical Success
Technical success is defined as successful placement of the Niti-S SPAXUS stent across the gastric(or duodenal) wall to the pseudocyst with visualization of the pseudocyst fluid drainage through the stent by endoscopy.
Time frame: Day 1
Population: If the stent is deployed successfully in the gastrointestinal tract and the pseudocyst, and if the drainage is confirmed visually, it is considered technically successful
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Niti-S SPAXUS Stent | Number of Participants With Technical Success | 33 Participants |
Secondary
Other Adverse Events
The severity and incidence of all other adverse events than those mentioned above occurred during the follow-up period were evaluated at Day 20 day after the stent removal.
Time frame: up to 90 days (at Day 20 post stent removal)
Population: The severity and incidence of all other adverse events than those mentioned above occurred during the follow-up period were evaluated at Day 20 day after the stent removal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Niti-S SPAXUS Stent | Other Adverse Events | 154 case |
Secondary
Procedure Time
Procedure time is measured as time from insertion until removal of endoscope. Procedure time 1: The time from the moment that the endoscope is inserted into the oral cavity to the time point at which the endoscope is removed. (sec) Procedure time 2: The time from the puncture time to the point at which the ultrasound endoscope was removed. (sec)
Time frame: 1 day
Population: The time is measured from the moment that the endoscope is inserted into the oral cavity to the time point at which the endoscope is removed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niti-S SPAXUS Stent | Procedure Time | Procedure time 1 | 1074.88 sec | Standard Deviation 618.3 |
| Niti-S SPAXUS Stent | Procedure Time | Procedure time 2 | 618.12 sec | Standard Deviation 341.63 |