A Prospective Randomized Multi-center Study for Efficacy of Metallic Biliary Stent Compared to Plastic Stent in Patients Receiving Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer

Pancreatic cancer is the eighth most common occurrence in Korea. In the United States, pancreatic cancer is expected to be the number two cause of death from cancer in 2030. The prevalence of pancreatic cancer is also on the rise in Korea. The 5-year survival rate of pancreatic cancer in Korea is 10.8%. According to the 2017 cause of death statistics, pancreatic cancer mortality is ranked fifth. It is known to have the worst prognosis of cancer in the body. The median survival period of unresectable pancreatic cancer is only six months, and resection is the only treatment that can be expected to be completely cured, but only about 10% of cases are possible to be operable at the time of diagnosis.

In the 2000s, the studies began to emerge on diagnosis and treatment of pancreatic cancer with intermediate anatomical and imaging characteristics of resectable and locally advanced pancreatic cancer. Margin negative resection plays an important role in the long-term survival rate in surgical treatment of pancreatic cancer. Prior to 2001, pancreatic cancer with invasion of vein was considered impossible to perform radical resection. However, the studies have been published that a satisfactory long-term survival rate and margin negative resection could be obtained when venous resection was performed along with radical resection. Since the 2006, the National Comprehensive Cancer Network (NCCN) guideline, after performing radical resection among locally advanced pancreatic cancers without remote metastasis, pancreatic cancers with high risk of margin positive resection and treatment failure were classified as "borderline resectable". In the borderline resectable pancreatic cancer, neoadjuvant therapy was recommended before surgery. In recent years, the neoadjuvant therapy has been reported to raise the survival rate in resectable pancreatic cancer. Furthermore, a prospective study is in progress to demonstrate the effectiveness of neoadjuvant therapy with FOLFIRINOX in resectable pancreatic cancer. If pancreatic cancer is located in the head of pancreas, jaundice can be occurred often. In the case of preoperative jaundice, the possibility of postoperative complications increases. So biliary drainage is performed before surgery. In biliary drainage, usually the plastic stent was inserted through the endoscope. If the metal stent is inserted in the biliary obstruction, it can cause severe inflammation around the bile duct due to the radial force, and it is difficult to remove in the surgery. However, the meta-analysis comparing the groups of metal and plastic stents in the recent preoperative biliary drainage showed no difference of postoperative complication, and postoperative pancreatic fistula was lower in the group of metal stents (5.1% vs. 11.8% p=0.04). In addition, fewer re-intervention cases before surgery were found in the group of metal stents (3.4% vs.14.8% p < 0.0001).

Not only in the borderline resectable, but also in the resectable pancreatic cancer, neoadjuvant therapy has recently been actively performed in the cases of large tumor size, high CA 19-9, large lymph nodes, severe weight loss, and severe pain. The comparison study of the efficacy between plastic and metal stents in preoperative bile drainage in pancreatic cancer with neoadjuvant therapy has not yet been prospectively performed. However, retrospective studies have shown that metal stents have a lower re-treatment rate than plastic stent (0.24 vs 0.54), and that there is no difference in post-operative complications. Therefore, we planned the study to compare the efficacy and safety between metal and plastic stent in biliary drainage performed in patients undergoing neoadjuvant therapy with pancreatic cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Resectable Pancreatic Cancer With Biliary Obstruction
• Intervention / Treatment: Device: ERCP using plastic stent; Device: ERCP using metal stent

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seung Min Bang; Phone Number: 82-2-2228-1995; Email: bang7028@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University Health System
    • Contact: Seung Min Bang; Phone Number: 82-2-2228-1995; Email: bang7028@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged 20 years or older who have confirmed histologically or radiologically resectable pancreatic cancer
2. Patients with clinical obstruction symptoms and radiographically confirmed biliary obstruction related to malignant tumors
3. Patients receiving neoadjuvant chemotherapy before surgery

Exclusion Criteria:

1. Patients diagnosed as unresectable pancreatic cancer
2. Patients with biliary obstruction due to biliary cancer, not pancreatic cancer
3. Patients with duodenal obstruction
4. Patients with pancreatic cance and other cancers
5. Patients with severe uncontrolled infection
6. Patients with 3 or higher of performance score as the Eastern Cooperative Oncology Group
7. Patients who have not agreed with the informed consent
8. Patients who are technically unable to be undergone endoscopic procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: The Plastic stent; Patient group with plastic stent inserted in biliary obstruction through endoscope	Device: ERCP using plastic stent; Insertion of plastic stent (plastic stent with inner diameter 1.8mm or more) in the biliary obstruction will be performed using ERCP in the patients with the pancreatic cancer undergoing neoadjuvant therapy.
EXPERIMENTAL: The metal stent; Patient group with metal stent inserted in biliary obstruction through endoscope	Device: ERCP using metal stent; Insertion of metal stent (full covered self-expandable metal stent) in the biliary obstruction will be performed using ERCP in the patients with the pancreatic cancer undergoing neoadjuvant therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-intervention rate	Re-intervention because of obstructive jaundice, cholangitis, stent malfunction, complication of procedure of ERCP	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure related complication, Postoperative complication	Complication because of procedure (ERCP); Complication because of surgery	6 months

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Seung Min Bang, Severance Hospital, Yonsei University Health System

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (ACTUAL): June 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 4-2021-0115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No