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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 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

116

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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.
Andra namn:
  • M-FCSEMS
Aktiv komparator: PS group
Participants in this arm will undergo endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic stent (PS) for preoperative biliary drainage.
Enhet: 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.
Andra namn:
  • PS

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Stent-Related Non-Event Rate at Surgery
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recurrent Biliary Obstruction Rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to surgery
The proportion of patients who undergo planned surgical resection after biliary drainage
Up to surgery
Overall Survival
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Soonchunhyang University Hospital

Samarbetspartners

Samsung Medical Center
Asan Medical Center

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 maj 2026

Primärt slutförande (Beräknad)

31 december 2028

Avslutad studie (Beräknad)

31 december 2029

Studieregistreringsdatum

Först inskickad

6 maj 2026

Först inskickad som uppfyllde QC-kriterierna

18 maj 2026

Första postat (Faktisk)

26 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2025-08-001

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

IPD-planbeskrivning

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.

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