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Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction (BRIDGE-8)

18 mei 2026 bijgewerkt door: Il Sang Shin, Soonchunhyang University Hospital

Multicenter Randomized Trial of a Short Modified 8-mm-diameter Fully Covered Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction

This study is a multicenter, randomized clinical trial designed to compare the effectiveness and safety of a modified 8-mm fully covered self-expandable metal stent (FCSEMS) with a conventional plastic stent for preoperative biliary drainage in patients with pancreatic cancer and malignant biliary obstruction.

In patients who require biliary drainage before surgery, stent placement is commonly performed using endoscopic retrograde cholangiopancreatography (ERCP). However, the optimal stent type remains uncertain.

Participants will be randomly assigned to receive either the modified FCSEMS or a plastic stent. The primary objective is to evaluate the rate of stent-related complications requiring reintervention before surgery. Secondary outcomes include stent patency, adverse events, and surgical outcomes.

The results of this study are expected to help determine the most appropriate stent strategy for patients undergoing surgery for pancreatic cancer.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Pancreatic cancer is a highly aggressive malignancy with a poor prognosis, and many patients present with malignant biliary obstruction at the time of diagnosis. Preoperative biliary drainage is frequently required in patients undergoing neoadjuvant chemotherapy or delayed surgery to relieve jaundice and prevent complications such as cholangitis.

Endoscopic retrograde cholangiopancreatography (ERCP) with stent placement is the standard approach for biliary drainage. Plastic stents (PS) are widely used due to their low cost and ease of removal; however, they are associated with a relatively short patency and frequent occlusion, often necessitating repeated interventions. Fully covered self-expandable metal stents (FCSEMS) have demonstrated longer patency, but concerns remain regarding adverse events and potential impact on subsequent surgical procedures.

A modified non-flared 8-mm diameter FCSEMS has been developed to reduce complications while maintaining adequate patency. Its design includes a dumbbell-shaped structure with a narrower central portion to prevent migration, a fully covered membrane to reduce tissue ingrowth, and a retrieval lasso to facilitate removal. This design may offer advantages over both conventional FCSEMS and plastic stents in the preoperative setting.

This study is a prospective, multicenter, open-label, randomized controlled trial designed to compare a modified 8-mm FCSEMS with a plastic stent for preoperative biliary drainage in patients with pancreatic cancer and malignant biliary obstruction. Eligible patients will be randomly assigned in a 1:1 ratio to receive either the modified FCSEMS or a plastic stent.

The primary endpoint is the stent-related non-event rate at the time of surgery, defined as the proportion of patients who do not require reintervention due to stent-related complications before surgery. Secondary endpoints include the incidence of recurrent biliary obstruction, time to recurrent biliary obstruction, stent-related adverse events, technical success, surgical outcomes, and overall survival.

All procedures will be performed using standard ERCP techniques by experienced endoscopists. Patients will be followed until surgery and throughout the postoperative period to assess clinical outcomes.

The findings of this study are expected to provide evidence to guide optimal stent selection for preoperative biliary drainage in patients with pancreatic cancer, particularly in the context of neoadjuvant treatment strategies.

Studietype

Ingrijpend

Inschrijving (Geschat)

116

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Patients with resectable, borderline resectable, or locally advanced pancreatic cancer with distal malignant biliary obstruction requiring endoscopic biliary drainage
  3. Biliary stricture located ≥ 2 cm below the hepatic hilum
  4. Serum bilirubin ≥ 3 mg/dL
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  6. Ability to provide written informed consent

Exclusion Criteria:

  1. Presence of distant metastasis
  2. Prior biliary stent placement for biliary obstruction
  3. Requirement for duodenal stent placement due to gastric outlet obstruction
  4. Estimated life expectancy < 3 months
  5. Inability to undergo ERCP
  6. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study outcomes

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: M-FCSEMS group
Participants in this arm will undergo endoscopic retrograde cholangiopancreatography (ERCP) with placement of a modified 8-mm fully covered self-expandable metal stent (FCSEMS) for preoperative biliary drainage.
Apparaat: Modified 8-mm Fully Covered Self-Expandable Metal Stent
A modified non-flared 8-mm fully covered self-expandable metal stent designed for preoperative biliary drainage. The stent features a dumbbell-shaped structure with a narrower central portion to reduce migration, a fully covered membrane to prevent tissue ingrowth, and a retrieval lasso to facilitate removal. It is deployed via ERCP across the malignant biliary stricture.
Andere namen:
  • M-FCSEMS
Actieve vergelijker: PS group
Participants in this arm will undergo endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic stent (PS) for preoperative biliary drainage.
Apparaat: Plastic stent
A conventional 8.5-Fr plastic biliary stent used for preoperative biliary drainage. The stent is placed via ERCP across the malignant biliary stricture and represents the standard treatment option, although it is associated with shorter patency and a higher risk of occlusion compared to metal stents.
Andere namen:
  • PS

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Stent-Related Non-Event Rate at Surgery
Tijdsspanne: From stent placement to the time of surgery
The proportion of patients who do not require reintervention due to stent-related complications from stent placement until the time of surgery.
From stent placement to the time of surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recurrent Biliary Obstruction Rate
Tijdsspanne: From stent placement to RBO, assessed up to 24 months
The proportion of patients who develop recurrent biliary obstruction requiring reintervention
From stent placement to RBO, assessed up to 24 months
Time to Recurrent Biliary Obstruction
Tijdsspanne: From stent placement to first RBO, assessed up to 24 months
Time from stent placement to the occurrence of recurrent biliary obstruction
From stent placement to first RBO, assessed up to 24 months
Stent-Related Adverse Events
Tijdsspanne: Within 30 days after procedure
Incidence of adverse events related to stent placement, including pancreatitis, cholangitis, cholecystitis, bleeding, perforation, or stent migration
Within 30 days after procedure
Technical Success Rate
Tijdsspanne: During the index procedure
Successful placement of the stent across the target biliary stricture in the intended position
During the index procedure
Surgery Completion Rate
Tijdsspanne: Up to surgery
The proportion of patients who undergo planned surgical resection after biliary drainage
Up to surgery
Overall Survival
Tijdsspanne: From procedure to death from any cause, assessed up to 24 months
Time from stent placement to death from any cause
From procedure to death from any cause, assessed up to 24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Soonchunhyang University Hospital

Medewerkers

Samsung Medical Center
Asan Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2026

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

6 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2026

Eerst geplaatst (Werkelijk)

26 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

18 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-08-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

A plan for sharing individual participant data has not been finalized. Any future data sharing will be considered in accordance with institutional policies, ethical standards, and regulatory requirements.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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