Colonic ESD Lidocaine Injection Trial

JRCT ID: jRCT1051230189

Registered date:27/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colonic neoplasms
• Date of first enrollment: 27/02/2024
• Target sample size: 110
• Study type: Interventional

Intervention(s)

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 ratio of 1:1 is used as the local injection solution for ESD.

Outcome(s)

• Primary Outcome: Procedure time
• Secondary Outcome: Peristalsis that interferes with ESD procedure, antispasmodic drug usage, en bloc resection rate, R0 resection rate, operator satisfaction, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takashi Kanesaka