UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062721 |
|---|---|
| Receipt number | R000071814 |
| Scientific Title | A Multicenter Randomized Controlled Trial of Appetite-Preserving Gastrectomy Versus Proximal Gastrectomy for Esophagogastric Junction Cancer |
| Date of disclosure of the study information | 2026/08/28 |
| Last modified on | 2026/08/28 12:27:44 |
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Basic information
Public title
A Multicenter Study Comparing Appetite-Preserving Gastrectomy and Proximal Gastrectomy for Esophagogastric Junction Cancer
Acronym
APG-PG Trial
Scientific Title
A Multicenter Randomized Controlled Trial of Appetite-Preserving Gastrectomy Versus Proximal Gastrectomy for Esophagogastric Junction Cancer
Scientific Title:Acronym
APG-PG Trial
Region
| Japan |
Condition
Condition
Esophagogastric junction cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and functional preservation effects of Appetite-Preserving Gastrectomy (APG) compared with Proximal Gastrectomy (PG) in patients with esophagogastric junction cancer in a multicenter randomized controlled trial. The primary endpoint is the between-group difference in the percentage change in Skeletal Muscle Index (SMI) from baseline to 6 months after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Between-group difference in the percentage change in Skeletal Muscle Index (SMI), measured on CT images at the L3 level, from baseline to 6 months after surgery between the APG and PG groups. The assessment will be performed at 6 months after surgery.
Key secondary outcomes
SNAQ score at baseline and 1, 3, 6, and 12 months after surgery.
Plasma des-acyl ghrelin concentration at baseline and 1, 6, and 12 months after surgery.
Nutritional and inflammatory markers (Alb, PreAlb, TP, Hb, and CRP) at baseline and 1, 3, 6, and 12 months after surgery.
Changes in lean body mass (LBM) at baseline and 1, 3, 6, and 12 months after surgery.
Changes in CT-based bone density, assessed using the trabecular CT value of the L1 vertebral body, at baseline and 6 and 12 months after surgery.
Percentage change in body weight at baseline and 1, 3, 6, and 12 months after surgery.
Incidence of postoperative complications of Clavien-Dindo grade III or higher within 30 days after surgery, reoperation rate, and length of hospital stay.
90-day postoperative mortality.
Initiation, continuation, and completion rates of postoperative adjuvant chemotherapy.
Recurrence-free survival (RFS) and overall survival (OS), with follow-up for up to 5 years.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Appetite-Preserving Gastrectomy (APG) is performed. The gastric fundus containing the ghrelin-producing region is preserved while ensuring an oncologically safe resection margin. Reconstruction consists of esophagojejunostomy and gastrojejunostomy using the preserved stomach. Open, laparoscopic, or robot-assisted approaches are permitted.
Interventions/Control_2
Proximal Gastrectomy (PG) is performed. Reconstruction is performed according to the standard procedure at each participating institution, including esophagogastrostomy, double-tract reconstruction, the Kamikawa procedure, or other reconstruction methods. Open, laparoscopic, or robot-assisted approaches are permitted.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male or female patients aged 20 to 85 years at enrollment.
Patients with esophagogastric junction adenocarcinoma classified as Siewert type II.
Patients considered eligible for curative (R0) resection, irrespective of clinical stage.
Patients are eligible regardless of whether preoperative chemotherapy has been administered.
Patients without severe comorbidities that would preclude safe gastrectomy.
Patients without organ failure or severe psychiatric disorders who are considered fit for surgery under general anesthesia.
Patients who have received sufficient explanation regarding the purpose and procedures of the study and have provided written informed consent.
Key exclusion criteria
Patients with a history of previous gastrectomy.
Patients with active synchronous or metachronous malignancy.
Patients with distant metastasis detected by preoperative imaging.
Patients with severe cardiac, respiratory, hepatic, renal, or other comorbidities that preclude surgery under general anesthesia.
Patients with severe active infection.
Women who are pregnant or breastfeeding.
Patients with psychiatric disorders or cognitive impairment that may interfere with understanding the study or providing appropriate informed consent.
Patients who are expected to have difficulty completing scheduled follow-up during the study period.
Patients considered unsuitable for participation in the study by the principal investigator or a study investigator.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hiki |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
nhiki@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Higuchi |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
higuchi.tadashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
Kitasato University School of Medicine and Hospital Ethics Committee
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
Tel
042-778-8273
rinri@med.kitasato-u.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
| 2026 | Year | 08 | Month | 28 | 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 | 07 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071814
