Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?

Pancreatic Cancer Clinical Trial

Official title:

Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03350763
• Other study ID #: HUS/2470/2017
• Status: Withdrawn
• Phase: N/A
• Start date: November 18, 2017
• Est. completion date: December 2025

Study information

• Verified date: May 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded.

This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Resectable tumor of the head of the pancreas

• Elevated serum bilirubin levels

• Radiologically visible dilatation of the biliary system

Exclusion Criteria:

• Distant metastasis

• Inoperable tumor or other reason, why the patient is unfit for surgery

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• Tannenbaum 10 Fr biliary stent
Tannenbaum 10 Fr biliary stent
• Self-expandable metallic biliary stent
ie WallFlex biliary RX

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Decker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4. — View Citation

Haapamäki C, Seppänen H, Udd M, Juuti A, Halttunen J, Kiviluoto T, Sirén J, Mustonen H, Kylänpää L. Preoperative biliary decompression preceding pancreaticoduodenectomy with plastic or self-expandable metallic stent. Scand J Surg. 2015 Jun;104(2):79-85. doi: 10.1177/1457496914543975. Epub 2014 Jul 15. — View Citation

Velanovich V, Kheibek T, Khan M. Relationship of postoperative complications from preoperative biliary stents after pancreaticoduodenectomy. A new cohort analysis and meta-analysis of modern studies. JOP. 2009 Jan 8;10(1):24-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.		Evaluation at the day of pancreatic surgery
Secondary	Other complications related to preoperative biliary decompression, and post-surgical complications		Complication emerged within 120 days from pancreaticoduodenectomy