UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060947 |
|---|---|
| Receipt number | R000069748 |
| Scientific Title | Reflux Esophagitis After Reconstruction Following Minimally Invasive Proximal Gastrectomy for Upper Gastric and Esophagogastric Junction Cancer |
| Date of disclosure of the study information | 2026/03/16 |
| Last modified on | 2026/03/16 16:09:23 |
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Basic information
Public title
Study on Reconstruction Methods and Reflux Symptoms After Minimally Invasive Proximal Gastrectomy for Upper Gastric and Esophagogastric Junction Cancer
Acronym
PG-Reflux Study
Scientific Title
Reflux Esophagitis After Reconstruction Following Minimally Invasive Proximal Gastrectomy for Upper Gastric and Esophagogastric Junction Cancer
Scientific Title:Acronym
PG-Reflux Study
Region
| Japan |
Condition
Condition
Proximal gastric cancer or Siewert Type II esophagogastric junction cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence and timing of postoperative reflux esophagitis and anastomotic stricture after proximal gastrectomy for upper gastric cancer and esophagogastric junction cancer, as well as treatment interventions for esophagitis and stricture, quality of life, and nutritional status.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative reflux esophagitis after proximal gastrectomy for upper gastric and esophagogastric junction cancer
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with histologically confirmed pStage I-III common-type upper gastric cancer or esophagogastric junction cancer. Esophagogastric junction cancer was limited to cases up to Siewert type II that were resected and reconstructed using an abdominal approach alone.
2. Patients who underwent minimally invasive proximal gastrectomy (laparoscopic or robot-assisted) with R0 resection.
3. Age: 20 years or older at the time of surgery.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of registration.
5. Patients within 5 years after surgery for the primary disease.
6. No restriction on sex.
7. Surgeon criteria: either the primary surgeon or the assistant must be certified by the Endoscopic Surgical Skill Qualification System of the Japan Society for Endoscopic Surgery (JSES).
Key exclusion criteria
1. Patients judged to be inappropriate for inclusion in this study by the principal investigator or a sub-investigator.
2. Patients who underwent combined resection of other organs, except for cholecystectomy performed for cholelithiasis.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Sato |
Organization
Yokohama City University Medical Center
Division name
Department of Surgery, Gastroenterological Center
Zip code
232-0024
Address
Urafunecho 4-57, Minami-ku, Yokohama City, Kanagawa
TEL
0452615656
shosato@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Sato |
Organization
Yokohama City University Medical Center
Division name
Department of Surgery, Gastroenterological Center
Zip code
232-0024
Address
Urafunecho 4-57, Minami-ku, Yokohama City, Kanagawa
TEL
0452615656
Homepage URL
shosato@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Yokohama City University
Address
Fukuura 3-9, Kanazawa-ku, Yokohama City, Kangawa
Tel
045-370-7627
rinri@yokohama-cu.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
福井大学医学部附属病院、京都府立医科大学附属病院、高知大学医学部附属病院、山梨大学医学部附属病院、大分大学医学部附属病院、名古屋大学医学部附属病院、鹿児島大学病院、滋賀医科大学医学部附属病院、国立がん研究センター東病院、金沢大学附属病院、岩手医科大学附属病院、奈良県立医科大学附属病院、群馬大学医学部附属病院、国立がん研究センター中央病院、昭和医科大学横浜市北部病院、自治医科大学附属病院、熊本大学病院、慶応義塾大学病院、神戸大学医学部附属病院、千葉大学医学部附属病院、東京慈恵会医科大学附属病院 、北海道大学病院、聖マリアンナ医科大学、大阪国際メディカル＆サイエンスセンター 大阪けいさつ病院、大阪医科薬科大学病院、がん研有明病院、岐阜大学医学部附属病院、埼玉医科大学国際医療センター、神奈川県立がんセンター、北里大学病院、独立行政法人地域医療機能推進機構 横浜保土ケ谷中央病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 16 | 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
| 2026 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary endpoint is the incidence of reflux esophagitis at 12 months after surgery, defined as grade B or higher according to endoscopic findings.
Management information
Registered date
| 2026 | Year | 03 | Month | 16 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069748
