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Colonic ESD Lidocaine Injection Trial

Efficacy of Lidocaine Injection in Colonic ESD: A Single Center Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051230189
Enrollment
110
Registered
2024-02-27
Start date
2024-02-27
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

Colonic neoplasms

Interventions

Lidocaine injection group: A mixture of sodium alginate and 1% lidocaine at a ratio of 1:1 is used as the local injection solution for ESD. Control group: A mixture of sodium alginate and saline at a

Sponsors

Takashi Kanesaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients scheduled to undergo ESD for colonic neoplasms (2) Patients who are at least 18 years old at the time of enrollment (3) Patients with a performance status (PS) of 0-2 according to ECOG criteria (4) Patients who have given written consent to participate in the study.

Exclusion criteria

Exclusion criteria: (1) Patients with hypersensitivity to lidocaine (2) Patients with serious comorbidities (liver cirrhosis, renal failure, heart failure, hematological disease, etc.) (3) Pregnant patients (4) Patients who have already been enrolled in the study (5) Patients who are judged to be inappropriate as research subjects by the principal investigator or subinvestigators.

Design outcomes

Primary

MeasureTime frame
Procedure time

Secondary

MeasureTime frame
Peristalsis that interferes with ESD procedure, antispasmodic drug usage, en bloc resection rate, R0 resection rate, operator satisfaction, adverse events

Contacts

Public ContactUeda Tomoya

Department of gastrointesitinal oncology, Osaka International Cancer Institute

t.ueda0204@gmail.com+81-6-6945-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Aug 31, 2026