Clinical trial · Interventional
Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage
Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complications of Surgical Procedures or Medical Care | — | UNRESOLVED | — |
| Disorder of Bile Duct Stent | — | UNRESOLVED | — |
| Periampullary Cancer | Periampullary Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fully covered metal stents | Device | — | UNRESOLVED |
| Plastic stents | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Plastic stents
- description
- Plastic stents are inserted by ERCP
- interventionNames
- Device: Plastic stents
- type
- EXPERIMENTAL
- label
- Fully covered metal stents
- description
- Fully covered metal stents are inserted by ERCP
- interventionNames
- Device: Fully covered metal stents
Primary outcomes (1)
- measure
- Adverse events related to the stent insertion
- timeFrame
- up to 4weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Older than 20 years old of age * Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer * No evidence of distant metastases or locally advanced tumor Exclusion Criteria: * Unresectable stage of cancer * Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis) * Severe gastric outlet obstruction or duodenal obstruction * Severe comorbidity (Karnofsky\<50%)
References
Publications (1)
- DERIVEDSong TJ, Lee JH, Lee SS, Jang JW, Kim JW, Ok TJ, Oh DW, Park DH, Seo DW, Lee SK, Kim MH, Kim SC, Kim CN, Yun SC. Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection. Gastrointest Endosc. 2016 Nov;84(5):814-821. doi: 10.1016/j.gie.2016.04.018. Epub 2016 Apr 22. PMID 27109456