UMIN-CTR Clinical Trial

Public title

A multicenter prospective study to determine the optimal range of lymph node dissection in pancreatic cancer surgery after neoadjuvant chemotherapy

Acronym

LYMRIN trial

Scientific Title

A multicenter prospective study to determine the optimal range of lymph node dissection in pancreatic cancer surgery after neoadjuvant chemotherapy(-Project study by the Japan Pancreas Society and JON 2302-P-)

Scientific Title:Acronym

LYMRIN trial

Region

Japan

Condition

Pancreatic invasive ductal adenocarcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine	Hepato-biliary-pancreatic surgery	Operative medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We design to perform radical pancreatectomy and lymph node dissection specified in the protocol (prospective interventional study) for the patients with resectable pancreatic cancer after neoadjuvant chemotherapy. The purpose of this study is to verify the validity of the index of lymph node dissection effect in each lymph node and to determine the optimal extent of lymph node dissection.

Basic objectives2

Others

Basic objectives -Others

Percentage of metastases in each lymph node in the standard NAC cohort patients who met the primary analysis criteria.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

Percentage of metastases in each lymph node in the standard NAC cohort patients who met the primary analysis criteria.

Key secondary outcomes

-The index of lymph node dissection in each lymph node in the standard NAC cohort patients who met the primary analysis criteria (percentage of lymph node metastasis x 3-year recurrence free survival, or percentage of lymph node metastasis x 5-year recurrence free survival).
-1,2,3,4,5-year recurrence-free survival rate and overall survival rate, recurrence-free survival , overall survival, disease-specific survival, disease-specific survival rate, postoperative complications, site of recurrence.
-Percentage of metastases in each lymph node, and the index of lymph node dissection (percentage of lymph node metastasis x 3-year recurrence free survival, or percentage of lymph node metastasis x 5-year recurrence free survival) in each lymph node about non-standard cohort patients or in standard NAC cohort patients who did not meet the primary analysis criteria.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Intervention is defined as radical primary resection (pancreaticoduodenectomy or distal pancreatectomy) and regional lymph node dissection from the start to the end of surgery. Regional lymph node is defined in the 8th edition of the Japanese classification of pancreatic cancer, and lymph node dissection is absolutely performed according to the tumor location.

Interventions/Control_2

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

#Pancreatic invasive ductal adenocarcinoma
#Resectable primary tumor
#NO history of upper abdominal surgery
#Reginal lymph node dissection possible by imaging diagnosis
#Negative peritoneal cytology
#Neoadjuvant chemotherapy
#Indication for radical primary tumor resection within 28 days after completion of preoperative chemotherapy
#Surgical operation: pancreatic head cancer (pancreaticoduodenectomy), pancreatic body and tail cancer (distal pancreatectomy)
#Pancreatic invasive ductal adenocarcinoma
#Resectable primary tumor
#NO history of upper abdominal surgery
#Reginal lymph node dissection possible by imaging diagnosis
#Negative peritoneal cytology
#Neoadjuvant chemotherapy
#Indication for radical primary tumor resection within 28 days after completion of preoperative chemotherapy
#Surgical operation: pancreatic head cancer (pancreaticoduodenectomy), pancreatic body and tail cancer (distal pancreatectomy)
#Performance Status (ECOG) 0-1

Key exclusion criteria

#Active synchronous cancers
#Severe complication
#Inability to safely perform protocol surgery
#Pretreatment other than protocol neoadjuvant chemotherapy
#Pregnant, lactating woman or possible pregnancy
#Psychiatric illness that interferes with daily life

Target sample size

545

Name of lead principal investigator

1st name	Tsutomu
Middle name
Last name	Fujii

Organization

University of Toyama

Division name

Department of Surgery and Science

Zip code

930-0194

Address

2630, Sugitani, Toyama 930-0194 Japan

TEL

076-434-7331

Email

fjt@med.u-toyama.ac.jp

Name of contact person

1st name	Katsuhisa
Middle name
Last name	Hirano

Organization

University of Toyama

Division name

Department of Surgery and Science

Zip code

930-0194

Address

2630, Sugitani, Toyama 930-0194 Japan

TEL

076-434-7331

Homepage URL

Email

hrnkths@med.u-toyama.ac.jp

Institute

University of Toyama

Institute

Department

Personal name

Organization

Department of Surgery and Science, University of Toyama

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Japan Pancreas Society
Japan Oncology Network in Hepatobiliary and Pancreas

Name of secondary funder(s)

Japan Pancreas Society

Organization

Ethics Committee,University of Toyama

Address

2630, Sugitani, Toyama 930-0194 Japan

Tel

076-415-8857

Email

rinri@adm.u-toyama.ac.jp

Secondary IDs

YES

Study ID_1

JON 2302-P

Org. issuing International ID_1

Japan Oncology Network in Hepatobiliary and Pancreas

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

旭川医科大学（北海道）、大阪市立総合医療センター（大阪府）、大阪大学医学部附属病院（大阪府）、大原記念倉敷中央医療機構倉敷中央病院（岡山県）、香川大学医学部附属病院（香川県）、鹿児島大学病院（鹿児島県）、関西医科大学（大阪府）、九州大学大学院医学研究院（福岡県）、京都大学医学部附属病院（京都府）、杏林大学医学部付属病院（東京都）、近畿大学（大阪府）、慶応義塾大学（東京都）、埼玉県立がんセンター（埼玉県）、札幌医科大学病院（北海道）、自治医科大学（栃木県）、自治医科大学附属さいたま医療センター（埼玉県）、順天堂大学医学部附属順天堂医院（東京都）、千葉県がんセンター（千葉県）、千葉大学医学部附属病院（千葉県）、大阪国際がんセンター（大阪府）、東海大学医学部附属病院（神奈川県）、神奈川県立がんセンター（神奈川県）、東京医科大学（東京都）、東京慈恵会医科大学（東京）、東北大学（宮城県）、獨協医科大学埼玉医療センター（埼玉県）、獨協医科大学病院（栃木県）、名古屋セントラル病院（愛知県）、名古屋大学（愛知県）、奈良県立医科大学（奈良県）、兵庫医科大学（兵庫県）、弘前大学医学部附属病院（青森県）、尾道総合病院（広島県）、藤田医科大学医学部ばんたね病院（愛知県）、藤田医科大学病院（愛知県）、北海道大学病院（北海道）、三重大学医学部附属病院（三重県）、宮崎大学（宮崎県）、山形大学（山形県）、山口大学（山口県）、和歌山県立医科大学（和歌山県）

Date of disclosure of the study information

2023

Year

10

Month

01

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

Preinitiation

Date of protocol fixation

2023

Year

08

Month

31

Day

Date of IRB

Anticipated trial start date

2023

Year

10

Month

01

Day

Last follow-up date

2031

Year

10

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

08

Month

09

Day

Last modified on

2025

Year

04

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059119