Exploratory study to evaluate the safety of robot-assisted resection of the retroperitoneal tumor using Hinotori surgical system in patients with retroperitoneal tumor

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032240274

Enrollment

Registered

2024-08-13

Start date

2025-01-15

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

Retroperitoneal tumor

Interventions

Perform robot-assisted resection of the retroperitoneal tumor using Hinotori surgical system in patients with retroperitoneal tumor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals diagnosed with retroperitoneal tumors via biopsy or imaging. 2. Age: Individuals aged 18 years or older at the time of obtaining consent. 3. Gender: Not specified. 4. Individuals who have received sufficient explanation about the study, have a thorough understanding, and provide written consent of their own free will after adequate comprehension. 5. Individuals capable of outpatient visits according to the research schedule.

Exclusion criteria

Exclusion criteria: 1. Individuals who have laboratory test results at the time of obtaining consent that are Grade 3 or higher according to JCOG version CTCAE 5.0. 2. Individuals with severe liver impairment, renal impairment, cardiovascular diseases, or respiratory diseases (judged with reference to Grade 3 of JCOG version CTCAE 5.0). 3. Individuals who cannot temporarily discontinue anticoagulant therapy during the perioperative period. 4. Individuals with a predisposition to bleeding. 5. Individuals who are pregnant or potentially pregnant. 6. Others judged by the principal investigator or collaborating investigator as unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
The incidence rate of major complications during surgery and within one-month post-operation	—

Secondary

Measure	Time frame
1. Intraoperative blood loss 2. Requirement for blood transfusion from intraoperative period to one-week post-operation 3. Console time 4. Rate of positive margins 5. Pain at the surgical site preoperatively, at discharge, and one-month post-operation (Numeric Rating Scale) 6. Change in fatigue assessment preoperatively and one-month post-operation (Brief Fatigue Inventory) 7. Change in frailty assessment preoperatively and one-month post-operation (G8 Screening Tool)	—

Measure

Time frame

1. Intraoperative blood loss 2. Requirement for blood transfusion from intraoperative period to one-week post-operation 3. Console time 4. Rate of positive margins 5. Pain at the surgical site preoperatively, at discharge, and one-month post-operation (Numeric Rating Scale) 6. Change in fatigue assessment preoperatively and one-month post-operation (Brief Fatigue Inventory) 7. Change in frailty assessment preoperatively and one-month post-operation (G8 Screening Tool)

—

Contacts

Public ContactYuta Yamada

The University of Tokyo Hospital

YAMADAYU-URO@h.u-tokyo.ac.jp+81-3-3815-5411

Outcome results

None listed

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