UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic exploration for the incidence of gastrojejunal anastomotic ulcer in patients undergoing subtotal stomach preserving pancreatoduodenectomy
Title of the study (Brief title)	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	Yukihiro Yokoyama
Organization	Nagoya University Graduate School of Medicine
Division name	Division of Perioperative Medicine, Department of Surgery
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	Yukihiro Yokoyama
Organization	Nagoya University Graduate School of Medicine
Division name	Division of Perioperative Medicine, Department of Surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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