Partially Covered Metal Stents Efficacy in Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction

NCT ID: NCT04431427

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2022-08-31

Brief Summary

Malignant obstructions of the bile duct are not rare. The most common and accepted method for biliary drainage is endoscopic stent placement. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk of migration, although data in the literature are discordant. Therefore the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS. After metallic biliary stent insertion, enrolled patients will be followed for 12 months.

Detailed Description

Malignant obstructions of the bile duct are generally caused by: adenocarcinoma of the Vater ampulla, pancreas head cancer, cholangiocarcinoma and external compression secondary to lymph node (LN) metastasis. The management of jaundice and cholangitis, as a result of bile stenosis, is crucial in this group of patients. The most common and accepted method for biliary drainage is endoscopic stent placement with plastic stents or self-expandable metal stents (SEMS). In recent times, the use of SEMS has become more common as it provides longer times of patency and a reduced risk of adverse events such as cholangitic episodes. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk of migration, however different randomized and non-randomized studies have compared the outcome of U-SEMS vs FC-SEMS with between uncovered and covered stents have produced different results regarding the cumulative patency of stents and endoscopic re-intervention rates. To date, there are few and discordant prospective data on the outcomes of PC-SEMS use in malignant biliary obstructions.

Therefore, the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS (T0 timing).

Then the participants will be followed for total period of 12 months. 2 different timings of follow-up will be considered:

• T1: it will start after stent insertion. The biliary drainage will be considered effective, according to the European guidelines, when the bilirubin values will be < or = 2 mg/dl for a period of at least 6 weeks if the initial bilirubin values were higher than 10 mg/dl or 3 weeks if at the beginning were lower than 10 mg/dl; After this first phase, all the enrolled patients will be divided in 2 groups according to their "fitness" for chemiotherapy: FIT and UNFIT Group.

FIT group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study once every three months.

UNFIT Group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study after 3, 9 and 12 months.

Conditions

Biliary Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Partially Covered Metal Stent Arm

The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl.

Group Type: ACTIVE_COMPARATOR

Biliary drainage with PC-SEMS

Intervention Type: DEVICE

partially covered metallic biliary stent insertion during ERCP

Uncovered Metal Stent Arm

The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl.

Group Type: ACTIVE_COMPARATOR

Biliary drainage with U-SEMS

Intervention Type: DEVICE

Uncovered metallic biliary stent insertion during ERCP

Interventions

Biliary drainage with PC-SEMS

partially covered metallic biliary stent insertion during ERCP

Intervention Type: DEVICE

Biliary drainage with U-SEMS

Uncovered metallic biliary stent insertion during ERCP

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

•The patients who had malignant biliary obstruction with a estimated survival >4 months

Exclusion Criteria

• The patients who had resectable biliary malignancy
• The patients who had hilar obstruction
• The patients who had duodenal obstruction
• The patients who had International Normalized Ratio (INR)>1.5
• The patients who did not give informed consent
• The patients who had technically difficult structure for Endoscopic retrograde cholangiopancreatography (ERCP)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santi Mangiafico

OTHER

Sponsor Role: lead

Responsible Party

Santi Mangiafico

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

SILVIA COCCA, MD

Role: CONTACT

cocca.silvia@aou.mo.it

00393756213301

Santi Mangiafico, MD

Role: CONTACT

mangiafico.santi@aou.mo.it

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Other Identifiers

05.2020

Identifier Type: -

Identifier Source: org_study_id