Lactobacillus oral care and the incident rate of Pneumonia after esophagectomy for Esophageal Cancer patients.

JRCT ID: jRCTs021230010

Registered date:16/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pneumonia and anastomotig leakage after esophagectomy for eophageal cancer patients
• Date of first enrollment: 16/06/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Improvement of oral environment with toothpaste and mouse wash containing Lactobacillus

Outcome(s)

• Primary Outcome: The incident rate of pneumonia more than Clavien-Dindo II
• Secondary Outcome: The incident rate of anastomotic leakage more than Clavien-Dindo I

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Patient who were pathologically diagnosed with Esophageal cancer, including Squamous cell carcinoma, adenocarcinoma, malignant melanoma, and other histological types.
2) Patient who and whose family selected esophagectomy with reconstruction as treatment.
3) Patient who were approved for esophagectomy even with other cancer.
4) Patient over 20 and under 85 years old at agreement.
5) Patient who agreed with written consent based on his free-will after a sufficient explanation.

Exclude criteria

1) Patient who were not approved for esophagectomy before esophagectomy, or who and whose family declined esophagectomy.
2) Patient who needed period of suspension (more than 1 week) of interventional drug.
3) Patient who were not appropriate for inclusion.

Related Information

• Primary Sponsor: Sato Yusuke
• Source(s) of Monetary Support: JEX INC.