Comparison Between Novel Flower-type Covered Stent and Conventional Covered Stent

Comparison Between Novel Flower-type Covered Stent and Conventional Covered Stent in Malignant Extrahepatic Biliary Obstruction: Prospective Randomized Multicenter Study

The aim of this animal study is determining the technical feasibility of the novel flower-type covered self-expandable metal stent (F-CSEMS) and investigating whether the novel flower-type covered self-expandable metal stent (F-CSEMS) could prevent cholecystitis and pancreatitis, comparing with conventional covered self-expandable metal stent (C-CSEMS).

Study Overview

• Status: Unknown
• Conditions: Malignant Biliary Obstruction
• Intervention / Treatment: Device: Endoscopic Retrograde CholangioPancreatography(ERCP)

Detailed Description

Covered self-expandable metal stent (C-CSEMS) has the risk of obstruction of the cystic duct, and the main and branch pancreatic ducts due to strong radial force and covering material, which results in cholecystitis and pancreatitis.

A flower-type covered self-expandable metal stent (F-CSEMS) having a five-petal-shaped design with side grooves was constructed to prevent the obstruction of the cystic duct orifice.

This study investigated the value of the F-CSEMS in protection for cholecystitis and pancreatitis.

The investigators will enroll patients with distal MBO (Malignant Biliary Obstruction) who received placement at the Samsung Medical Center. Transpapillary flower-type covered self-expandable metal stent (F-CSEMS) placements will be included in this study.

The diagnosis of MBO will be based on imaging and/or pathological findings. Malignancy was proved by histopathological confirmation obtained by endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA), bile duct biopsy (cytology), pancreatic duct cytology, or liver biopsy.

The investigators will evaluate the frequency of pancreatitis and cholecystitis.

Furthermore, the investigators will evaluate various parameters to clarify the predictive factors of pancreatitis and cholecystitis. The following 10 variables will be evaluated in pancreatitis by univariate analysis: [1] sex, [2] age, [3] primary disease, [4] Covered type (partially or fully), [5] SEMS with high AF, [6] F-CSEMS with high RF, [7] EST before F-CSEMS, [8] previous biliary stent, [9] contrast injection into the pancreatic duct (pancreatogram), and [10] the position of the distal stent edge.

The following 11 variables will be evaluated in cholecystitis by univariate analysis: [1] sex, [2] age, [3] regions of stricture, [4] F-CSEMS with high AF AF (axial force), [5] F-CSEMS with high RF, [6] previous biliary stent, [7] gallbladder stone, [8] contrast injection into the gallbladder (GB injection), [9] involvement to the orifice of the cystic duct (OCD), [10] position of distal stent edge, and [11] cystic duct occlusion by F-CSEMS.

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software: nQuery + nTerim (version 4.0)

- One-sided Chi-square test for proportion comparison

H0: p1=p2 vs H1: p1>p2 (The incidence of complications in the flower-type covered stent is smaller than in the conventional stent.)

p1 = incident rate of complication in full covered stent group p2 = incident rate of complication in flower-type covered stent group

• Set p1(incident rate of complication in full covered stent group) = 15% = 0.15
• expected % decrement in incidence rate = 40%, 50%, 60%, 70% --> p2 = 0.09, 0.075, 0.06, 0.045
• Significance level (alpha) = 0.05
• Maximum number of patients who can be enrolled = 10 per month at SMC = 120 per year

• Expected enroll period = 1 year = 12 months

  1. Sample size calculation with targeted power of 80% Expected % decrement in incidence rate 70% p2 4.5% Required n per group 116 Required total sample size 232 Required enroll period (year) 1.9
  2. Power calculation with a total sample size of 232 (116 per group) Expected % decrement in incidence rate 40% 50% 60% 70% p2 9.0% 7.5% 6.0% 4.5% Expected power (%) 32 48 64 80
  3. Minimum % decrement to be detected with power of 80% Planned enroll period (year) 1 1.5 2 2.5 3 Enroll-able n per group 60 90 120 150 180 Enroll-able total sample size 120 180 240 300 360 Minimum % decrement to be detected 93.33% 78.70% 68.70% 62.70% 58.00% Expected p2 1.0% 3.2% 4.7% 5.6% 6.3%

• Study Type: Interventional
• Enrollment (Anticipated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jong Kyun Lee, MD PhD; Phone Number: +82-2-3410-3409; Email: jongk.lee@samsung.com
• Study Contact Backup: Name: Jae Keun Park, MD; Phone Number: +82-2-3410-3409; Email: jaekeunjaekeun.park@samsung.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, KS013
    • Recruiting
    • SamsungMC
    • Contact: Jae Keun Park, MD; Phone Number: +82-3410-3409; Email: jaekeunjaekeun.park@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults from 19 to 85 years of age who have voluntarily agreed to the clinical trial and signed a written agreement
• Patients with malignant extrahepatic bile duct obstruction without surgery

Exclusion Criteria:

• Patients who had already undergone surgical biliary drainage
• Patients who previously underwent percutaneous spinal cholecystectomy (PTGBD)
• Patients who underwent conventional metal-on-metal self-expandable metal stents (C-CSEMS)
• Patients who underwent biliary plastic stent implantation for more than 15 days
• Patients with malignant stricture of the intrahepatic bile duct and patients with stenosis within 2 cm of the liver
• Patients whose expected life expectancy is less than 3 months
• Pregnant patient
• Patients who can not undergo endoscopic procedures based on the judgment of the researcher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flower-CSEMS; EGIS Flower Biliary Full Covered Stent(Flower-CSEMS), Bile Duct Stent, (S & G Biotech Co., Ltd.) will be inserted by using Endoscopic Retrograde CholangioPancreatography(ERCP).	Device: Endoscopic Retrograde CholangioPancreatography(ERCP); This study is prospective randomized multicenter study by using Endoscopic Retrograde CholangioPancreatography(ERCP). Comparison between Novel flower-type covered stent and Conventional covered stent in malignant extrahepatic biliary obstruction will be conducted after stent insertion by using Endoscopic Retrograde CholangioPancreatography(ERCP).
Experimental: Conventional-CSEMS; Conventional-CSEMS (S & G Biotech Co., Ltd.) will be inserted by using Endoscopic Retrograde CholangioPancreatography(ERCP).	Device: Endoscopic Retrograde CholangioPancreatography(ERCP); This study is prospective randomized multicenter study by using Endoscopic Retrograde CholangioPancreatography(ERCP). Comparison between Novel flower-type covered stent and Conventional covered stent in malignant extrahepatic biliary obstruction will be conducted after stent insertion by using Endoscopic Retrograde CholangioPancreatography(ERCP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancreatitis, Cholecystitis - Occurrence rate : %	The incidence of pancreatitis is calculated using percentiles.	3 months after procedure
Pancreatitis, Cholecystitis - Severity	The extent of each side effect is described in the Adverse Reactions Report according to the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) Rating System version 4.0.	3 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent-related adverse events	Post -ERCP pancreatitis, Severity of pancreatitis, Bleeding, Microperforation	6 months after procedure
Stent patency	We followed up the stent patency until the time of patient death or stent occlusion.	6 months after procedure

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Jong Kyun Lee, MD PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): July 12, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: July 9, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2017-03-098-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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