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

NCT07606430 | Not Yet Recruiting

• 1 other identifier: 2025-08-001
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pancreatic Cancer; Malignant Biliary Obstruction

Keywords

pancreatic cancer; malignant biliary obstruction; preoperative biliary drainage; ERCP; fully covered self-expandable metal stent; plastic stent

Outcome Measures

Primary Outcomes (1)

• 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.

  From stent placement to the time of surgery

Secondary Outcomes (6)

• Recurrent Biliary Obstruction Rate

  From stent placement to RBO, assessed up to 24 months

• Time to Recurrent Biliary Obstruction

  From stent placement to first RBO, assessed up to 24 months

• Stent-Related Adverse Events

  Within 30 days after procedure

• Technical Success Rate

  During the index procedure

• Surgery Completion Rate

  Up to surgery

Study Arms (2)

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.

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.

Device: Plastic stent

Interventions

Modified 8-mm Fully Covered Self-Expandable Metal Stent DEVICE

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.

Also known as: M-FCSEMS

M-FCSEMS group

Plastic stent DEVICE

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.

Also known as: PS

PS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator

Related Publications (4)

• 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.

  PMID: 10450725 BACKGROUND

• 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.

  PMID: 34750863 BACKGROUND

• 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.

  PMID: 30618170 BACKGROUND

• 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.

  PMID: 29717230 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Il Sang Shin, Assistant Professor

CONTACT

+82-10-4658-8794; ilsang.shin@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is conducted as an open-label trial. Due to the nature of the endoscopic procedures and the visible differences between the stent types, blinding of participants, care providers, and investigators is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 26, 2026

Record last verified: 2026-05