PROspective randomized controlled pilot study of double-Tract jejunal reconstruction adding to subtotal stomach reconstruction for Esophageal Cancer Treatment

PROspective randomized controlled pilot study of double-Tract jejunal reconstruction adding to subtotal stomach reconstruction for Esophageal Cancer Treatment - PROspective randomized controlled pilot study of double-Tract jejunal reconstruction adding to subtotal stomach reconstruction for Esophageal Cancer Treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060117

Enrollment

Registered

2025-12-18

Start date

2026-01-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Intervention group: Subtotal gastric reconstruction plus double-tract gastrojejunostomy (conventional method + jejunal double-tract method) Control group: Conventional subtotal gastric reconstruction

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactYoshihiro Tanaka

Gifu University Gastroenterological Surgery

tanaka.yoshihiro.h5@f.gifu-u.ac.jp058-230-6000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026