UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033919
Receipt number R000038677
Scientific Title Endoscopic Application of Clipping, Over-the-scope clip (OTSC) and Stenting for a fistula and anastomotic leakage of gastro- intestinal tract.
Date of disclosure of the study information 2018/09/01
Last modified on 2019/03/20 18:10:29

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Basic information

Public title

Endoscopic Application of Clipping, Over-the-scope clip (OTSC) and Stenting for a fistula and anastomotic leakage of gastro- intestinal tract.

Acronym

Clipping, Over-the-scope clip (OTSC) and Stenting Application for a fistula and anastomotic leakage of GI tract.

Scientific Title

Endoscopic Application of Clipping, Over-the-scope clip (OTSC) and Stenting for a fistula and anastomotic leakage of gastro- intestinal tract.

Scientific Title:Acronym

Clipping, Over-the-scope clip (OTSC) and Stenting Application for a fistula and anastomotic leakage of GI tract.

Region

Japan


Condition

Condition

Fistula and anastomotic leakage of gastro- intestine after surgery

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purposes of this study are to prevent serious infectious state, to shorten hospital inpatient day and cost for medical material and drug

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Leakage or fistula is evaluated by contrast examination on the operation day, third day, a week later and a month later.

Key secondary outcomes

The term of disappearance of leakage, and fistula and cost including hospital charges, a medical care material and drug costs after treatment are calculated. We compare them between this endoscopic treatment and conventional conservative therapy and surgery.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Undergo clipping, over-the-scope clip and tenting for a fistula and anastomotic leakage of gastro- intestine after surgery.

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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with leakage or fistula after gastrointestinal surgery

Key exclusion criteria

Patients with general condition with pyothorax, panperitonitis and sepsis.
Patients of necessary emergency operation.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Makino

Organization

Nippon Medical School, Tama Nagayama Hospital

Division name

Department of Surgery

Zip code

206-8512

Address

1-7-1, Nagayama, Tama, Tokyo, Japan, ZIP206-8512

TEL

0423712111

Email

himiyumo@nms.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Makino

Organization

Nippon Medical School, Tama Nagayama Hospital

Division name

Department of Surgery

Zip code

206-8512

Address

1-7-1, Nagayama, Tama, Tokyo, Japan, ZIP206-8512

TEL

0423712111

Homepage URL


Email

himiyumo@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School,

Tama Nagayama Hospital,

Department of Surgery

Institute

Department

Personal name



Funding Source

Organization

Nippon Medical School,

Tama Nagayama Hospital,

Department of Surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nippon Medical School, Tama Nagayama Hospital, Department of Surgery

Address

1-7-1, Nagayama, Tama, Tokyo, Japan, ZIP206-8512

Tel

0423712111

Email

himiyumo@nms.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



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 01 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

Preinitiation

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 27 Day

Last modified on

2019 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038677


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name