A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'

Not Applicable

Completed

• Conditions: Pancreatic Pseudocyst
• Interventions: Device: Niti-S SPAXUS Stent

• Registration Number: NCT02730663
• Lead Sponsor: Taewoong Medical Co., Ltd.

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.

Study Timeline

• Study Start: 2016-03-21
• Study First Submitted: 2016-03-28
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Primary Completion: 2017-06-14
• Study Completion: 2017-06-14
• Results First Submitted: 2018-06-19
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-08
• Results First Posted: 2019-07-01
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Niti-S SPAXUS Stent	Niti-S SPAXUS Stent	Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 Stent Lumen Patency	up to 60 days (at stent removal, Day 30 or 60)	Stent lumen patency will be evaluated by endoscopy.
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.
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.
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)

Trial Locations

Locations (6)

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of

Hallym University Dongtan Sacred Heart Hospital; 🇰🇷 Hwaseong-si, Gyeonggi-do, Korea, Republic of

Kyungpook National University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chonbook National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of