UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060117 |
|---|---|
| Receipt number | R000068756 |
| Scientific Title | PROspective randomized controlled pilot study of double-Tract jejunal reconstruction adding to subtotal stomach reconstruction for Esophageal Cancer Treatment |
| Date of disclosure of the study information | 2025/12/18 |
| Last modified on | 2025/12/18 11:52:10 |
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Basic information
Public title
PROspective randomized controlled pilot study of double-Tract jejunal reconstruction adding to subtotal stomach reconstruction for Esophageal Cancer Treatment
Acronym
PROTECT Study
Scientific Title
PROspective randomized controlled pilot study of double-Tract jejunal reconstruction adding to subtotal stomach reconstruction for Esophageal Cancer Treatment
Scientific Title:Acronym
PROspective randomized controlled pilot study of double-Tract jejunal reconstruction adding to subtotal stomach reconstruction for Esophageal Cancer Treatment
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Short-term Postoperative Outcomes (DTGE Incidence Rate)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short-term Postoperative Outcomes (DTGE Incidence Rate)
*DTGE evaluation is based on the amount of food residue in the thoracic cavity (area measurement at the maximum retention slice) on CT scan at 3 months after surgery.
Key secondary outcomes
The overall incidence of complications according to the Clavien-Dindo classification, length of hospital stay, weight change, body composition (skeletal muscle mass and lean body mass measured by a body composition scale), muscle strength (grip strength and 4-meter walk test), nutritional indicators (Alb, prealbumin, total protein, lymphocyte count, total cholesterol level), dietary intake, readmission rate, and QOL indicators according to the EORTC QLQ-OES18 will be evaluated at discharge from the hospital and at 3, 6, and 12 months. Endoscopy at 12 months will evaluate the amount of gastric residue and the presence or absence of anastomotic ulcers with the cervical esophagus.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group: Subtotal gastric reconstruction plus double-tract gastrojejunostomy (conventional method + jejunal double-tract method)
Interventions/Control_2
Control group: Conventional subtotal gastric reconstruction (conventional method)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled to undergo radical resection with esophagectomy via thoracic manipulation for esophageal cancer or esophagogastric junction cancer at our hospital
2) Patients eligible for one-stage reconstruction
3) Patients eligible for reconstruction using a subtotal gastric tube
4) Patients for whom written consent has been obtained from the patient or their representative
Key exclusion criteria
1) Patients requiring reconstruction using the colon or small intestine
2) Unresectable cases with distant metastasis (Stage IVb) or cases with T4a tumor invasion depth before chemotherapy and a high risk of postoperative mediastinal recurrence
3) Patients planning for two-stage reconstruction
4) Patients undergoing retrosternal reconstruction
5) Patients with a history of curative (chemo)radiotherapy for esophageal or pharyngeal cancer
6) Patients deemed inappropriate for research by the attending physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Tanaka |
Organization
Gifu University
Division name
Department of Gastroenterological surgery
Zip code
501-1194
Address
1-1, Yanagido, Gifu City
TEL
058-230-6000
tanaka.yoshihiro.h5@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Tanaka |
Organization
Gifu University
Division name
Gastroenterological Surgery
Zip code
501-1194
Address
1-1Yanagido, Gifu City
TEL
058-230-6000
Homepage URL
tanaka.yoshihiro.h5@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Gifu University School of Medicine, Ethics Committee
Address
1-1Yanagido, Gifu City
Tel
058-230-6000
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 | 12 | Month | 18 | 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 | 12 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 12 | 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
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068756
