Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction (BRIDGE-8)
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Il Sang Shin, Assistant Professor
- Telefonní číslo: +82-10-4658-8794
- E-mail: ilsang.shin@schmc.ac.kr
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age ≥ 18 years
- Patients with resectable, borderline resectable, or locally advanced pancreatic cancer with distal malignant biliary obstruction requiring endoscopic biliary drainage
- Biliary stricture located ≥ 2 cm below the hepatic hilum
- Serum bilirubin ≥ 3 mg/dL
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Ability to provide written informed consent
Exclusion Criteria:
- Presence of distant metastasis
- Prior biliary stent placement for biliary obstruction
- Requirement for duodenal stent placement due to gastric outlet obstruction
- Estimated life expectancy < 3 months
- Inability to undergo ERCP
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study outcomes
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
Ostatní jména:
|
|
Aktivní komparátor: PS group
Participants in this arm will undergo endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic stent (PS) for preoperative biliary drainage.
|
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Stent-Related Non-Event Rate at Surgery
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Recurrent Biliary Obstruction Rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Up to surgery
|
The proportion of patients who undergo planned surgical resection after biliary drainage
|
Up to surgery
|
|
Overall Survival
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Povoski SP, Karpeh MS Jr, Conlon KC, Blumgart LH, Brennan MF. Association of preoperative biliary drainage with postoperative outcome following pancreaticoduodenectomy. Ann Surg. 1999 Aug;230(2):131-42. doi: 10.1097/00000658-199908000-00001.
- Shin IS, Moon JH, Lee YN, Chung JC, Jeong J, Choi SY, Lee TH, Yang JK, Cha SW, Cho YD, Park SH. Modified non-flared fully covered self-expandable metal stent for preoperative biliary drainage in pancreatic cancer. J Gastroenterol Hepatol. 2022 Jan;37(1):225-232. doi: 10.1111/jgh.15733. Epub 2021 Nov 19.
- Lee HW, Moon JH, Lee YN, Chung JC, Lee TH, Choi MH, Cha SW, Cho YD, Park SH. Modified non-flared fully covered self-expandable metal stent versus plastic stent for preoperative biliary drainage in patients with resectable malignant biliary obstruction. J Gastroenterol Hepatol. 2019 Sep;34(9):1590-1596. doi: 10.1111/jgh.14600. Epub 2019 Feb 27.
- Neoptolemos JP, Kleeff J, Michl P, Costello E, Greenhalf W, Palmer DH. Therapeutic developments in pancreatic cancer: current and future perspectives. Nat Rev Gastroenterol Hepatol. 2018 Jun;15(6):333-348. doi: 10.1038/s41575-018-0005-x.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025-08-001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .