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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035752
Receipt No. R000040727
Scientific Title Endoscopic exploration for the incidence of gastrojejunal anastomotic ulcer in patients undergoing subtotal stomach preserving pancreatoduodenectomy
Date of disclosure of the study information 2019/04/01
Last modified on 2019/02/02

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Basic information
Public title Endoscopic exploration for the incidence of gastrojejunal anastomotic ulcer in patients undergoing subtotal stomach preserving pancreatoduodenectomy
Acronym Endoscopic exploration for the incidence of gastrojejunal anastomotic ulcer after SSPPD
Scientific Title Endoscopic exploration for the incidence of gastrojejunal anastomotic ulcer in patients undergoing subtotal stomach preserving pancreatoduodenectomy
Scientific Title:Acronym Endoscopic exploration for the incidence of gastrojejunal anastomotic ulcer after SSPPD
Region
Japan

Condition
Condition Patients who underwent subtotal stomach preserving pancreatoduodenectomy (SSPPD)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To perform endoscopic exploration of the incidence of gastrointestinal anastomotic ulcer following SSPPD.
Basic objectives2 Others
Basic objectives -Others To perform endoscopic exploration for the incidence of gastrojejunal anastomotic ulcer in patients undergoing SSPPD. Intestinal juice samples obtained from the stomach, afferent loop, and efferent loop were subjected for the analysis of bilirubin, S-amylase, P-amylase, and lipase concentrations and pH.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. The association between the incidence of gastrojejunal anastomotic ulcer and various clinical factors.
Key secondary outcomes 2. The association between the condition of gastrojejunal anastomosis and intestinal juice (bilirubin, s-amylase, p-amylase, and lipase levels and pH).
3. The association between the condition of intestinal juice and various clinical factors.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Upper gastrointestinal endoscopy
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 Patients who underwent SSPPD in Nagoya University Hospital and followed up for more than 6 months after surgery.
Includes benign and malignant lesions.
Key exclusion criteria 1. Patients who disagreed to participate the study.
2. Patients who can not undergo upper gastrointestinal endoscopy.
3. Patients with severe comorbidities (e.g., heart disease, respiratory system disease, renal disease, hepatic disease, etc.).
4. Patients with severe psychiatric disease.
5. Patients with dimentia.
6. Patients who are not suitable for this study (by physician's decision)
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Yokoyama
Organization Nagoya University Graduate School of Medicine
Division name Division of Perioperative Medicine, Department of Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan 4668550
TEL 052-744-2222
Email yyoko@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Yokoyama
Organization Nagoya University Graduate School of Medicine
Division name Division of Perioperative Medicine, Department of Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan 4668550
TEL 052-744-2222
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine, Division of Perioperative Medicine, Department of Surgery
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 04 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
2019 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 31 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
2019 Year 02 Month 02 Day
Last modified on
2019 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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