UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety of endoscopic papillectomy after a pancreatic stent placement above the pancreatic duct orifice
Title of the study (Brief title)	Inside pancreatic stenting papillectomy
Region	Japan

Condition
Condition	Tumors of the major duodenal papilla
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of endoscopic snare papillectomy after a pancreatic stent placement above the pancreatic duct orifice (inside pancreatic stenting papillectomy).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Technical success rate Incidence of complications
Key secondary outcomes	Residual tumor rate Tumor recurrence rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Placement of pancreatic stent and endoscopic papillectomy
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Protruded-type tumors of the major duodenal papilla 2) Lesion confined to the major duodenal papilla without spread into the bile duct or pancreatic duct 3) Patients who provided written informed consent
Key exclusion criteria	1) Distant metastases to other organs and lymph nodes 2) Hemorrhagic tendency in patients receiving oral anticoagulants, those with hepatic cirrhosis with coagulation disorders 3) Possibility of the pregnancy 4) Patients who were judged inappropriate for the entry to this study by the investigators
Target sample size	20

Research contact person
Name of lead principal investigator	Kazunari Nakahara
Organization	St. Marianna University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL	044-977-8111
Email

Public contact
Name of contact person	Kazunari Nakahara
Organization	St. Marianna University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL	044-977-8111
Homepage URL
Email

Sponsor
Institute	Department of Gastroenterology and Hepatology, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 01 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 01 Day
Last modified on	2017 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012156