Argon Plasma Coagulation Ablation Therapy for Upper GI-esophageal Intramucosal Carcinoma

JRCT ID: jRCTs012240006

Registered date:01/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Superficial esophageal cancer
• Date of first enrollment: 01/05/2024
• Target sample size: 54
• Study type: Interventional
• Intervention(s): APC therapy was administered to research subjects with superficial esophageal cancer who were thought to be intolerant to EMR and ESD, and the local complete response rate 3 months after surgery, local recurrence-free survival period, recurrence-free survival period, safety, etc. Consider.

Outcome(s)

• Primary Outcome: Local complete response (L-CR) after 12 weeks from the argon plasma coagulation therapy.

Secondary Outcome

1) Local relapse free survival: L-RFS
2) Relapse free survival: RFS
3) Overall survival: OS
4) Changes of Instrumental Activities of Daily Living: IADL
5) Safety: Evaluate the incidence of the following adverse events
-Postoperative bleeding observed from the day of APC therapy to 7 and 28 days after APC therapy
-Adverse events observed from the day of APC therapy to 12 weeks after APC therapy
-Dysphagia (difficulty swallowing), stenosis (including anastomosis), GI associated with APC therapy observed from the day of APC therapy to 72 weeks after APC therapy
Even after the end of this study period, we plan to continue the follow-up surveys related to 1) to 3) above, and evaluate the overall survival rate (3-year survival rate, 5-year survival rate), etc.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Superficial cancer of the esophagus with cT1a-EP/LPM wall depth based on diagnostic endoscopic examination. Simultaneous or heterochronic multiple lesions are acceptable. Patients with or without a history of radiotherapy, chemotherapy, or endocrine therapy to the neck, chest, or abdomen, including treatments for other carcinomas.
2) The following conditions (a) and (b) are diagnosed by endoscopy. Biopsy at the patient's registered facility is not required as long as the histological type can be confirmed by a specimen borrowed from a previous physician or a pathology report.
(a)Patients with endoscopic biopsy diagnosed squamous cell carcinoma from the esophagus.
(b)Patients with indications for superficial esophageal cancer include lesions that are 3 cm or less in major axis, 1/3 or less circumferential, and equivalent to cT1a-EP/LPM.
3) No evidence of lymph node metastasis or distant metastasis (N0, M0) based on CT scan (contrast-enhanced is recommended).
4) Patients who are judged to have difficulty performing surgical treatment (surgery), EMR,or ESD
5) Patients who has any of the following (a) to (f)
(a)Patients with a Charlson comorbidity index of 3 or higher
(b)Patients who have comorbidities that require antithrombotic medication and who fall into a group with a high incidence of thromboembolism due to drug discontinuation
Refer to Gastrointestinal endoscopy treatment guidelines for patients taking antithrombotic drugs Vol.54(7), Jul.2012
(c)Patients who have esophageal varices of F1 or lower, or those who underwent endoscopic treatment for F2 or F3 and whose condition became F1 or lower
(d)Patients among blood diseases, those with decreased platelet count of 30,000liters or more
(e)Patients persons receiving oxygen due to chronic respiratory failure
(f)Patients who have had a history of endoscopic treatment in the past and have a test lesion in the scar area
6) ECOG Performance Status (PS) 1 to 3 (excluding patients with PS score 4)
7) Men and women. Age older than 20 years of age at the time consent is obtained.
8) Patients for whom written consent has been obtained from the patient or his/her legal representative regarding research participation.

Exclude criteria

1) Patient with with esophageal cancer and are eligible for surgical treatment (surgery) or chemoradiotherapy.
2) Patient with active multiple primary cancers (simultaneous multiple primary cancers and iatrogenic multiple primary cancers with a disease-free interval of 5 years or less). However, even if the disease-free interval is less than 5 years, a history of cancer equivalent to a 5-year relative survival rate of 95% or more, such as clinical stage I prostate cancer, clinical stage 0 or stage I laryngeal cancer with complete response to radiotherapy, or completely resected stage I, is not included in active overlapping cancer.
3) Patients with infectious diseases requiring systemic treatment.
4) Patients with a fever of 38 degrees Celsius or higher at the time of registration.
5) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the research.
6) Patients with hematologic malignancies (leukemia, malignant lymphoma, multiple myeloma) in the active stage of hematologic disease.
7) Patients with NYHA classification III or IV chronic heart failure and those with poorly controlled heart failure
8) Patients diagnosed with chronic respiratory failure and on non-invasive positive pressure ventilation (NPPV). However, patients on home oxygen therapy are excluded.
9) Pregnant or lactating mothers
10) Patients who are deemed inappropriate for inclusion in the study by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Ono Shoko
• Secondary Sponsor: Tanabe Satoshi
• Source(s) of Monetary Support: AMCO Incorporated