UMIN-CTR Clinical Trial

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

pancreatic cancer

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Gastrointestinal surgery
Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

First Dept. of Internal Medicine, Gifu University Hospital

Institute

Department

Personal name

Organization

First Dept. of Internal Medicine, Gifu University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Gifu Prefectural General Medical Center
Gifu Municipal Hospital

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岐阜大学医学部附属病院

Date of disclosure of the study information

2017

Year

03

Month

21

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

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 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.

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