UMIN-CTR Clinical Trial

Public title

A randomized controlled trial to verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice

Acronym

PCSEMS vs.UCSEMS for during neoadjuvant therapy in pancreatic cancer patients in RCT

Scientific Title

A randomized controlled trial to verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice

Scientific Title:Acronym

PCSEMS vs.UCSEMS for during neoadjuvant therapy in pancreatic cancer patients in RCT

Region

Japan

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice

Basic objectives2

Others

Basic objectives -Others

Non-inferiority

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Biliary event rate until surgery after biliary stenting with a metal stent

Key secondary outcomes

(1) curative resection rate
(2)Time to Recurrent biliary obstruction
(3)Chemotherapy accomplishment/delay/discontinuation
(4)Other stent-related adverse events
(5)Frequency and severity of adverse events after curative surgery

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Uncovered stent

Interventions/Control_2

Partially covered stent

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Pancreatic cancer patients with jaundice scheduled for neoadjuvant chemo-/chemoradiotherapy:
(1) pathological diagnosis of pancreatic ductal adenocarcinoma/adenosquamous carcinoma; (2) clinical diagnosis of resectable/borderline resectable pancreatic cancer according to the 7th edition of the General Rules for the Study of Pancreatic Cancer by the Japan Pancreas Society, which is almost equal to National Comprehensive Cancer Network (NCCN) Guideline Version 1.2020; (3) scheduled for neoadjuvant chemotherapy/chemoradiotherapy; (4) confirmed distal biliary obstruction (defined as stricture at the common bile duct located downstream of the confluence of the cystic duct according to the Classification of Biliary Tract Cancers established by the Japanese Society of Hepato-Biliary-Pancreatic Surgery: 3rd English edition) requiring endoscopic biliary drainage (or a history of endoscopic/percutaneous transhepatic biliary drainage using a plastic stent/tube), which leads to abnormal serum total bilirubin or liver function test results (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, or alkaline phosphatase values not within normal reference ranges at each institution) with or without bile duct dilatation; (5) being 20 or more years of age and (6) willingness to provide informed consent

Key exclusion criteria

(1) history of biliary drainage with a metal stent; (2) history of chemotherapy/chemoradiotherapy for pancreatic cancer; (3) biliary obstruction that progresses to the hepatic hilum; (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 4; (5) history of gastrointestinal tract reconstruction except for Billroth I reconstruction; (6) the major duodenal papilla unreachable by a duodenal endoscope; (7) current pregnancy or suspected pregnancy; (8) unsuitable for inclusion at the discretion of the physician

Target sample size

100

Name of lead principal investigator

1st name	Masaki
Middle name
Last name	Kuwatani

Organization

Hokkaido University Hospital

Division name

Gastroenterology and Hepatology

Zip code

060-8648

Address

West 5, North 14, Kita-ku, Sapporo

TEL

011-716-1161

Email

mkuwatan@med.hokudai.ac.jp

Name of contact person

1st name	Masaki
Middle name
Last name	Kuwatani

Organization

Hokkaido University Hospital

Division name

Gastroenterology and Hepatology

Zip code

060-8648

Address

West 5, North 14, Kita-ku, Sapporo

TEL

011-716-1161

Homepage URL

Email

mkuwatan@med.hokudai.ac.jp

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

Hokkaido University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hokkaido University Certified Review Board

Address

West 5, North 14, Kita-ku, Sapporo, Hokkaido

Tel

011-706-7934

Email

recjimu@huhp.hokudai.ac.jp

Secondary IDs

YES

Study ID_1

jRCT1012200002

Org. issuing International ID_1

Japan Registry of Clinical Trials

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Hokkaido University Hospital (Hokkaido), Yokohama City University Medical Centre (Kanagawa), Mie University (Mie), Kagawa University (Kagawa), Shizuoka Cancer Centre (Shizuoka), Sapporo City Hospital (Hokkaido), Gifu University (Gifu), Sapporo Medical University (Hokkaido), Kagoshima University (Kagoshima), Wakayama Medical University (Wakayama), Asahikawa Medical University (Hokkaido), IMS Sapporo Digestive Disease Centre General Hospital (Hokkaido), and Teine-Keijinkai Hospital (Hokkaido)
This study was approved by the Institutional Review Board of Hokkaido University Hospital and the director of each above participating institution.

Date of disclosure of the study information

2020

Year

09

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2020

Year

03

Month

17

Day

Date of IRB

2020

Year

03

Month

17

Day

Anticipated trial start date

2020

Year

09

Month

23

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Data management and monitoring:
All sampled data will be linked and anonymised and stored in a password-protected server (NorthNet), which is accessible only by the permitted physicians according to internal information governance rules. The data will be analysed after completion of the study and no interim analysis is planned. Monitoring will be performed by an independent monitor for every participating institution, and the results including unintended effects of the trial interventions or trial conduct will be reported to the research representative and the director of Hokkaido University Hospital. Severe adverse events will be immediately reported to the research representative and the director of Hokkaido University Hospital.

Patient and public involvement:
All authors involved in treatment/assessment have years of clinical experience in treating pancreatic cancer, including biliary drainage, chemotherapy/chemoradiotherapy, and related adverse events. The leading pancreaticobiliary physicians and endoscopists contributed to the development of the research questions based on their current knowledge of treatments and interventions for pancreatic cancer.
Patients will be questioned and assessed about their body conditions including appetite, body weight, and body temperature and complaints throughout each observational period of the study. This will allow us to develop an appropriate preoperative biliary drainage method using a SEMS. This study will include 100 patients who are scheduled to undergo preoperative chemotherapy/chemoradiotherapy with pancreatectomy for primary pancreatic cancer. The aforementioned items and intervention burden will be assessed by the participating pancreaticobiliary physicians and endoscopists, but not by the patients themselves. The study results will be disseminated to the study participants through patient symposia and associations without lucrative purposes or organisations for patients with pancreatic cancer.

Registered date

2020

Year

09

Month

09

Day

Last modified on

2023

Year

09

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045492