UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026611 |
|---|---|
| Receipt number | R000029883 |
| Scientific Title | Comparing the effectiveness of endoscopic duodenal stent placement and surgical gastrojejunostomy to treat gastric outlet obstruction in patients with advanced pancreatic cancer |
| Date of disclosure of the study information | 2017/03/21 |
| Last modified on | 2019/03/22 16:10:52 |
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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
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
takuji@w7.dion.ne.jp
Public contact
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
ueshin550621@gmail.com
Sponsor or person
Institute
First Dept. of Internal Medicine, Gifu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029883
