Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures.

NCT02930252 | Completed

• 1 other identifier: 055REG2013
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the duration of stent patency of a covered vs. an uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction in patients with inoperable extrahepatic malignant biliary obstruction.

Conditions

Biliary Cancer

Keywords

Self-expandable metal stent; strictures; biliary

Outcome Measures

Primary Outcomes (2)

• To compare the duration of stent patency of a covered vs. an uncovered biliary SEMS placed to relieve biliary obstruction in patients with inoperable extrahepatic malignant biliary obstruction.

  The Kaplan-Meier method will be used to estimate stent patency in each group and the log-rank test will be used for an unadjusted comparison between groups. Then a Cox proportional hazard model will be constructed to compare time to stent occlusion adjusted for important potential confounders. Stent patency will be calculated in days and will represent the interval between the time of stent insertion and the time of its replacement or the death of the patient with concomitant cholangitis.

  minimum follow-up: 4 months

• To evaluate complication rates of covered vs. uncovered biliary SEMS in patients with inoperable extrahepatic malignant biliary obstruction

  Relationships between complication rates and stent type will be examined by the chi-square or the exact Fisher tests. Logistic regression will be used to compare stent complication rates adjusted for important potential confounders.

  minimum follow-up: 4 months

Secondary Outcomes (4)

• To evaluate the quality of life before and after intervention with covered vs. uncovered biliary SEMS in patients with inoperable extrahepatic malignant biliary obstruction.

  3 months

• To evaluate the survival of patients treated with covered vs. uncovered biliary SEMS for the management of inoperable extrahepatic malignant biliary obstruction.

  until death

• To evaluate the cost-effectiveness of covered and uncovered biliary SEMS in patients with inoperable extrahepatic malignant biliary obstruction

  until death

• To determine the predictors of survival in patients in patients with inoperable extrahepatic malignant biliary obstruction managed with SEMS.

  minimum follow-up: 4 months

Study Arms (2)

Niti-S Biliary ComVi Stent

EXPERIMENTAL

Device: Niti-S Biliary ComVi Stent is a hollow cylindrical stent fabricated by knitting first and second super-elastic shape memory alloy wires to make a net-like structure. A plurality of interlocked points allow each of the inside and outside stent bodies to contract and expand in the longitudinal direction and to apply a force against the longitudinal contraction. A hollow polytetrafluoroethylene (PTFE) membrane tube is closely fitted between the inside and outside stent bodies, with each of overlapped ends of the PTFE membrane tube and the inside and outside stent bodies integrated into a single structure.

Device: Niti-S Biliary ComVi Stent

Niti-S Stent (D-type)

ACTIVE COMPARATOR

Device: The Niti-S Stent (D-type) maintains a desired bent shape corresponding to the specific target lesion. It is comprised of a hollow cylindrical stent body fabricated by knitting first and second super-elastic shape memory alloy wires to make a net-like structure with a plurality of interlocked points capable of allowing the stent body to contract and expand in the longitudinal direction and to apply a force against the longitudinal contraction of the stent body. The wires are made of a shape memory alloy through a process of shaping the alloy then heat-treating the wires to allow restoration of the original shape at a predetermined temperature.

Device: Niti-S stent (D type)

Interventions

Niti-S Biliary ComVi Stent DEVICE

Endoscopic placement of biliary fully covered metal stents

Also known as: Fully Covered biliary stent

Niti-S Biliary ComVi Stent

Niti-S stent (D type) DEVICE

Endoscopic placement of biliary uncovered metal stent

Also known as: Uncovered biliary stent

Niti-S Stent (D-type)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Malignant obstructive disease at the level of the extrahepatic bile duct (CBD)
• Serum bilirubin \>50 micromol/L
• Inoperability due to a poor medical condition and/or unresectable disease
• ≥ 18 years of age
• Willing and able to comply with study procedures and provide written informed consent

You may not qualify if:

• Benign obstruction of the CBD
• Malignancy involving intrahepatic ducts or duodenum
• Prior gastric bypass or Billroth type I or type II gastric resection
• Prior biliary surgery
• World Health Organization (WHO) performance score of 4 (100% of time in bed)
• international normalized ratio (INR)\> 1.5
• Life expectancy of \< 90 days

Sponsors & Collaborators

• Azienda USL 1 Imperiese: lead
• Ospedali Riuniti Marche Nord, Pesaro, Italy: collaborator
• NOCSAE Hospital, Modena, Italy: collaborator
• University of Siena, Italy: collaborator
• Papa Giovanni XXIII Hospital: collaborator

Study Sites (1)

General Hospital sanremo

Sanremo, Imperia, 18038, Italy

Location

Related Publications (15)

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MeSH Terms

Conditions

Biliary Tract Neoplasms; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Conio, MD

  General Hospital Sanremo, Sanremo, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director of Gastroenterology Department, General Hospital Sanremo, Italy

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 12, 2016
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2016
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)