UMIN-CTR Clinical Trial

Basic information
Public title	Comparing the effectiveness of endoscopic duodenal stent placement and surgical gastrojejunostomy to treat gastric outlet obstruction in patients with advanced pancreatic cancer
Acronym	Comparing the effectiveness of endoscopic DS and surgical GJJ for GOO in patients with advanced pancreatic cancer
Scientific Title	Comparing the effectiveness of endoscopic duodenal stent placement and surgical gastrojejunostomy to treat gastric outlet obstruction in patients with advanced pancreatic cancer
Scientific Title:Acronym	Comparing the effectiveness of endoscopic DS and surgical GJJ for GOO in patients with advanced pancreatic cancer
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and safety of surgical gastrojejunostomy(GJJ) and endoscopic duodenal stenting(DS) as palliative treatments for gastric outlet obstruction(GOO) in patients with advanced pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To compare the survival duration after the procedure of GJJ with those of DS.
Key secondary outcomes	To compare the technical success rates, clinical success rates, adverse event, length of the hospital stay and chemotherapy start time of GJJ with those of DS.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Unresectable advanced pancreatic cancer (2) Intestinal obstruction located from the distal one-third of the stomach to the distal duodenum (3) Gastric Outlet Obstruction Scoring System (GOOSS) score of 0 (no oral intake) or 1 (liquids only)
Key exclusion criteria	We excluded those patients who had a structure in the proximal stomach or distal small intestine, another malignancy, a recurrent tumor, or a history of gastric or duodenal surgery, or had undergone previous gastrointestinal stent placement.
Target sample size	70

Research contact person
Last name of lead principal investigator	1st name Takuji Middle name Last name Iwashita
Organization	Gifu University Hospital
Division name	First Dept. of Internal Medicine
Zip code	501-1194
Address	1-1 Yanagido, Gifu 501-1194
TEL	058-230-6308
Email	takuji@w7.dion.ne.jp

Public contact
1st name of contact person	1st name Shinya Middle name Last name Uemura
Organization	Gifu University Hospital
Division name	First Dept. of Internal Medicine
Zip code	501-1194
Address	1-1 Yanagido, Gifu 501-1194
TEL	058-230-6308
Homepage URL
Email	ueshin550621@gmail.com

Sponsor
Institute	First Dept. of Internal Medicine, Gifu University Hospital
Institute
Department

Funding Source
Organization	First Dept. of Internal Medicine, Gifu University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Gifu Prefectural General Medical Center Gifu Municipal Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Gifu University Hospital Independent Ethics Committee
Address	1-1 Yanagido, Gifu
Tel	058-230-6059
Email	gjme00004@jim.gifu-u.ac.jp

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	岐阜大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date	2017 Year 03 Month 21 Day
Last follow-up date	2017 Year 03 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We retrospectively collected the data of consecutive patients who had undergone palliative treatment for GOO caused by pancreatic cancer at the Gifu University Hospital, Gifu Municipal Hospital, Gifu Prefectural General Medical Center between December 2008 and October 2015. we conducted this study to compare the efficacy and safety of GJJ with those of DS as types of palliative treatments for treating GOO in patients with advanced pancreatic cancer.

Management information
Registered date	2017 Year 03 Month 20 Day
Last modified on	2019 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029883