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

A Prospective, Multi-center, Single Arm, Non-inferiority, Open-label, Pivotal Study to Evaluate the Effectiveness and Safety of EUS -Guided Transluminal Drainage With 'Niti-S SPAXUS Stent' for the Treatment of Pancreatic Pseudocyst

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Pseudocyst
• Intervention / Treatment: Device: Niti-S SPAXUS Stent

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Medical Center
  • Jeonju, Korea, Republic of, 54907
    • Chonbook National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 14584
      • Soon Chun Hyang University Hospital Bucheon
    • Hwaseong-si, Gyeonggi-do, Korea, Republic of, 18450
      • Hallym University Dongtan Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Niti-S SPAXUS Stent; Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)	Device: Niti-S SPAXUS Stent; Endoscopic Ultrasound-Guided Transluminal drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Success	Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)	at stent removal (Day 30 or Day 60)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
Number of Participants With Stent Lumen Patency	Stent lumen patency will be evaluated by endoscopy.	up to 60 days (at stent removal, Day 30 or 60)
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.	up to 60 days (at stent removal, Day 30 or 60)
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)	1 day
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	up to 90 days (at Day 20 post stent removal)
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.	up to 90 days (at Day 20 post stent removal)

Collaborators and Investigators

• Sponsor: Taewoong Medical Co., Ltd.
• Investigators: Principal Investigator: Jong Ho Moon, PhD, MD, Soon Chun Hyang University; Principal Investigator: Sang Soo Lee, PhD, MD, Asan Medical Center; Principal Investigator: Jong Kyun Lee, PhD, MD, Samsung Medical Center; Principal Investigator: Seung-Ok Lee, PhD, MD, Chonbuk National University Hospital; Principal Investigator: Chang Min Cho, PhD, MD, Kyungpook National University Medical Center; Principal Investigator: Se Woo Park, PhD, MD, Hallym University Dongtan Sacred Heart Hospital

Publications and helpful links

General Publications

• Song TJ, Lee SS, Moon JH, Choi HJ, Cho CM, Lee KH, Park SW, Kim SH, Lee SO, Lee YN, Lee JK. Efficacy of a novel lumen-apposing metal stent for the treatment of symptomatic pancreatic pseudocysts (with video). Gastrointest Endosc. 2019 Sep;90(3):507-513. doi: 10.1016/j.gie.2019.05.033. Epub 2019 May 30.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2016
• Primary Completion (Actual): June 14, 2017
• Study Completion (Actual): June 14, 2017

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Endoscopic ultrasound guided transluminal drainage
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Pancreatic Diseases; Pancreatic Cyst; Pancreatic Pseudocyst
• Other Study ID Numbers: SPAXUS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Oct, 2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No