Preoperative Biliary Drainage With Metal Versus Plastic Stents in Periampullary Cancer

NCT02787512 | Completed

• 1 other identifier: SNUBH-IMGPB-2016-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery. The aim of this clinical trial is to demonstrate non-inferiority of uncovered self-expandable metal stent to plastic stent for PBD by endoscopic retrograde cholangiopancreatography in patients with periampullary cancer undergoing curative intent pancreaticoduodenectomy.

Conditions

Jaundice; Periampullary Cancer

Keywords

ERCP; stent; preoperative biliary drainage

Outcome Measures

Primary Outcomes (1)

• Reintervention rate until operation

  Between preoperative biliary drainage and surgery, reintervention (re-preoperative biliary drainage) would be checked and analyzed.

  Between preoperative biliary drainage and surgery

Secondary Outcomes (5)

• Other complication rate associated with endoscopic stent insertion and stent indwell

  Between preoperative biliary drainage and surgery

• Rate of decrease of total bilirubin

  Between preoperative biliary drainage and surgery

• Time to operation

  Between preoperative biliary drainage and surgery

• Time to hospital discharge after pancreaticoduodenectomy

  6 month

• Mortality until 3 months after pancreaticoduodenectomy

  3 month

Study Arms (2)

Plastic stent

ACTIVE COMPARATOR

10 Fr plastic stent (Percuflex Amsterdam® or C-flex pigtail® or Advanix® Biliary stent)

Device: Stent

Uncovered metal stent

EXPERIMENTAL

Uncovered metal stent (WallFlex® Biliary RX stent)

Device: Stent

Interventions

Stent DEVICE

Endoscopic biliary stent insertion

Plastic stent; Uncovered metal stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Patients 20-80 years old B. Patients with surgically resectable periampullary cancer on CT scans with or without MRI or PET-CT scans C. ECOG Performance score 0 or 1 D. Patients who need preoperative biliary drainage (PBD) because of one or more of following causes
• Cholangitis defined as revised Tokyo guidelines
• Level of total bilirubin \>= 10mg/dL
• Expected time to operation \>= 7 days

You may not qualify if:

• A. Patients who received previous endoscopic biliary drainage or percutaneous biliary drainage B. Patients with acute pancreatitis before PBD
• C. Patients with bleeding tendency or coagulopathy or anticoagulation therapy as follows:
• Patients who take clopidogrel within 5 days before PBD
• Patients who take warfarin within 2 days before PBD
• Patients who receive heparin within 1 days before PBD D. Patients with pregnancy or suspected pregnancy E. Patients who are currently enrolled in another investigational trials that would directly interfere with current study

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Related Publications (3)

• van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.

  PMID: 20071702 BACKGROUND

• Adams MA, Anderson MA, Myles JD, Khalatbari S, Scheiman JM. Self-expanding metal stents (SEMS) provide superior outcomes compared to plastic stents for pancreatic cancer patients undergoing neoadjuvant therapy. J Gastrointest Oncol. 2012 Dec;3(4):309-13. doi: 10.3978/j.issn.2078-6891.2011.050.

  PMID: 23205306 BACKGROUND

• 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.

  PMID: 21373939 BACKGROUND

MeSH Terms

Conditions

Jaundice

Interventions

Stents

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Jaihwan Kim, MD

  Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: June 1, 2016
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: February 12, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)