Pancreatic CancerBRIDGE-8NCT07606430
Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction
A study testing Modified 8-mm Fully Covered Self-Expandable Metal Stent and Plastic stent in people with Pancreatic Cancer and Malignant Biliary Obstruction, run by Soonchunhyang University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Malignant Biliary Obstruction
- What is being tested?
- Modified 8-mm Fully Covered Self-Expandable Metal Stent and Plastic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Pancreatic Cancer, Malignant Biliary Obstruction
- Being tested
- Modified 8-mm Fully Covered Self-Expandable Metal Stent, Plastic stent
- Keywords
- pancreatic cancer, malignant biliary obstruction, preoperative biliary drainage, ERCP, fully covered self-expandable metal stent, plastic stent
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified 8-mm Fully Covered Self-Expandable Metal StentDevice
Also called M-FCSEMS
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.
Plastic stentDevice
Also called PS
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.
| Study group | Role | What they receive |
|---|---|---|
| M-FCSEMS group | Experimental | 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. Receives: Device: Modified 8-mm Fully Covered Self-Expandable Metal Stent |
| PS group | Active comparator | Participants in this arm will undergo endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic stent (PS) for preoperative biliary drainage. Receives: Device: Plastic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent-Related Non-Event Rate at Surgery
The proportion of patients who do not require reintervention due to stent-related complications from stent placement until the time of surgery.
Measured: From stent placement to the time of surgery
Secondary outcomes (6)
Recurrent Biliary Obstruction Rate
The proportion of patients who develop recurrent biliary obstruction requiring reintervention
Measured: From stent placement to RBO, assessed up to 24 months
Time to Recurrent Biliary Obstruction
Time from stent placement to the occurrence of recurrent biliary obstruction
Measured: From stent placement to first RBO, assessed up to 24 months
Stent-Related Adverse Events
Incidence of adverse events related to stent placement, including pancreatitis, cholangitis, cholecystitis, bleeding, perforation, or stent migration
Measured: Within 30 days after procedure
Technical Success Rate
Successful placement of the stent across the target biliary stricture in the intended position
Measured: During the index procedure
Surgery Completion Rate
The proportion of patients who undergo planned surgical resection after biliary drainage
Measured: Up to surgery
Overall Survival
Time from stent placement to death from any cause
Measured: From procedure to death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either a modified 8-mm fully covered self-expandable metal stent or a plastic stent for preoperative biliary drainage.
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center
- Responsible party
- Principal investigator, Il Sang Shin, Soonchunhyang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606430
- Sponsor's protocol ID
- 2025-08-001
- Acronym
- BRIDGE-8
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 10450725Shin 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.
PubMed 34750863Lee 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.
PubMed 30618170Neoptolemos 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.
PubMed 29717230
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07606430
- Acronym / sponsor ID
- BRIDGE-8 / 2025-08-001
- Conditions
- Pancreatic Cancer, Malignant Biliary Obstruction
- Keywords
- pancreatic cancer, malignant biliary obstruction, preoperative biliary drainage, ERCP, fully covered self-expandable metal stent, plastic stent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either a modified 8-mm fully covered self-expandable metal stent or a plastic stent for preoperative biliary drainage.
| Arm | Type | Receives |
|---|---|---|
| M-FCSEMS group | Experimental | Device: Modified 8-mm Fully Covered Self-Expandable Metal StentParticipants 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. |
| PS group | Active comparator | Device: Plastic stentParticipants in this arm will undergo endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic stent (PS) for preoperative biliary drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified 8-mm Fully Covered Self-Expandable Metal StentAlso: M-FCSEMSA 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. | Device | M-FCSEMS group |
| Plastic stentAlso: PSA 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. | Device | PS group |
Primary outcome
Stent-Related Non-Event Rate at Surgery
Time frame: 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.
6 secondary outcomes
Recurrent Biliary Obstruction Rate
Time frame: From stent placement to RBO, assessed up to 24 months
Time to Recurrent Biliary Obstruction
Time frame: From stent placement to first RBO, assessed up to 24 months
Stent-Related Adverse Events
Time frame: Within 30 days after procedure
Technical Success Rate
Time frame: During the index procedure
Surgery Completion Rate
Time frame: Up to surgery
Overall Survival
Time frame: From procedure to death from any cause, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 10450725Povoski 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.
- Background: PubMed 34750863Shin 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.
- Background: PubMed 30618170Lee 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.
- Background: PubMed 29717230Neoptolemos 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Modified 8-mm Fully Covered Self-Expandable Metal Stent and Plastic stent in people with Pancreatic Cancer and Malignant Biliary Obstruction, run by Soonchunhyang University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Il Sang Shin, Assistant Professor (+82-10-4658-8794, ilsang.shin@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent-Related Non-Event Rate at Surgery (time frame: From stent placement to the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07606430, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.