UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035752 |
|---|---|
| Receipt number | 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 14:25:18 |
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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
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
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040727
