UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059651 |
|---|---|
| Receipt number | R000068233 |
| Scientific Title | A multicenter retrospective observational study on the impact of non-GAstric conduit ReconstruCtion ON postoperative outcomes after ESOphagectomy (ESO-GARCON Study) |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 18:33:32 |
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Basic information
Public title
A multicenter retrospective observational study on the impact of non-GAstric conduit ReconstruCtion ON postoperative outcomes after ESOphagectomy (ESO-GARCON Study)
Acronym
A multicenter retrospective observational study on the impact of non-GAstric conduit ReconstruCtion ON postoperative outcomes after ESOphagectomy (ESO-GARCON Study)
Scientific Title
A multicenter retrospective observational study on the impact of non-GAstric conduit ReconstruCtion ON postoperative outcomes after ESOphagectomy (ESO-GARCON Study)
Scientific Title:Acronym
A multicenter retrospective observational study on the impact of non-GAstric conduit ReconstruCtion ON postoperative outcomes after ESOphagectomy (ESO-GARCON Study)
Region
| Japan |
Condition
Condition
esophageal cancer, esophagogastric junction cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of non-gastric conduit reconstruction on postoperative outcomes after esophagectomy, this study aims to identify the optimal reconstruction method for non-gastric conduit cases and to compare both short- and long-term outcomes, including nutritional indicators, between colonic and jejunal reconstructions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative weight loss rate
Definition: The weight loss rate is defined as follows.
Weight loss rate at X years after reconstruction = (Body weight at X years after reconstruction - Preoperative body weight) / Preoperative body weight
Key secondary outcomes
Reduction rate of psoas muscle area, reduction rate of BMI
Nutritional indicators (PNI, NLR, PLR)
PNI: Prognostic Nutrition Index
NLR: Neutrophil-to-Lymphocyte Ratio
PLR: Platelet-to-Lymphocyte Ratio
Overall survival, relapse-free survival, progression-free survival
Intraoperative complication rate, postoperative complication rate, curative resection rate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet any of the following criteria will be included:
Patients with cervical, thoracic, or abdominal esophageal cancer, or esophagogastric junction cancer, who have a history of gastrectomy (regardless of whether the previous gastrectomy was for benign or malignant disease) and underwent curative resection with non-gastric conduit reconstruction (using colon or small intestine), either as a one-stage or staged procedure.
Patients with esophagogastric junction cancer requiring total esophagectomy and gastrectomy (or proximal gastrectomy) who underwent curative resection with non-gastric conduit reconstruction (using colon or small intestine), either as a one-stage or staged procedure.
Patients with double cancer involving the cervical, thoracic, or abdominal esophagus and stomach, requiring total esophagectomy and gastrectomy (or proximal gastrectomy), who underwent curative resection with non-gastric conduit reconstruction (using colon or small intestine), either as a one-stage or staged procedure. Cases of esophageal cancer with gastric invasion and gastric cancer with esophageal invasion will be handled in the same manner.
Patients who underwent curative resection with non-gastric conduit reconstruction (using colon or small intestine), either as a one-stage or staged procedure, due to intraoperative complications (e.g., intraoperative gastric conduit necrosis).
Among the above, eligible patients are those aged 18 years or older who underwent surgery between January 1, 2013, and December 31, 2023.
Key exclusion criteria
Patients who underwent non-gastric conduit reconstruction as a reoperation due to postoperative complications (e.g., anastomotic leakage, gastric conduit necrosis, tracheal fistula, or refractory reflux esophagitis).
Patients who underwent non-gastric conduit reconstruction following curative resection due to local recurrence of a prior disease or other related conditions.
Patients who underwent non-gastric conduit reconstruction for metachronous double cancer, such as gastric conduit cancer.
Patients who declined participation in this study through the optout process.
Patients deemed inappropriate for inclusion by the attending physician's judgment.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Sato |
Organization
Gifu University Hospital
Division name
Department of Gastrointestinal Surgery and Pediatric Surgery
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu, Japan
TEL
0582306000
m03039ys@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Sato |
Organization
Gifu University Hospital
Division name
Department of Gastrointestinal Surgery and Pediatric Surgery
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu, Japan
TEL
0582306000
Homepage URL
m03039ys@yahoo.co.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Medical Research of Gifu University
Address
1-1 Yanagido, Gifu City, Gifu, Japan
Tel
0582306059
rinri@t.gifu-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
| 2025 | Year | 11 | Month | 05 | 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
| 2025 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At each participating institution, patients who meet the inclusion and exclusion criteria and underwent surgery between January 1, 2013, and December 31, 2023, will be identified.
Collection of existing data:
Researchers will collect clinical data for each case using medical records and complete the case report forms provided by the study office.
Researchers will submit the collected data to the study office via email.
When necessary, researchers will provide preoperative CT images of eligible cases to the study office using electronic storage media (e.g., USB, DVD-ROM), ensuring that all personal identifiers are masked.
Management information
Registered date
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068233
