Clinical trial · Interventional

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

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

NCT07606430CI-TRIAL-00112604BRIDGE-8not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Malignant Biliary Obstruction	Pancreatic Neoplasm	PROBABILISTIC	0.70
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Modified 8-mm Fully Covered Self-Expandable Metal Stent	Device	—	UNRESOLVED
Plastic stent	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
M-FCSEMS group
description
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.
interventionNames
1. Device: Modified 8-mm Fully Covered Self-Expandable Metal Stent
type
ACTIVE_COMPARATOR
label
PS group
description
Participants in this arm will undergo endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic stent (PS) for preoperative biliary drainage.
interventionNames
1. Device: Plastic stent

Primary outcomes (1)

measure
Stent-Related Non-Event Rate at Surgery

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (4)

BACKGROUNDPovoski 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
BACKGROUNDShin 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
BACKGROUNDLee 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
BACKGROUNDNeoptolemos 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