The efficacy of Abound on anastomotic leakage after esophagectomy

JRCT ID: jRCTs041190018

Registered date:11/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Anastomotic leakage after esophagectomy
• Date of first enrollment: 27/08/2019
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Administration of Abound

Outcome(s)

• Primary Outcome: The period from the diagnosis to cure of the anastomotic leakage
• Secondary Outcome: Total amount and safety of Abound administration, duration of drain placement and fasting, hospital stay, location and procedure of anastomosis, blood test and nutritional management

Key inclusion & exclusion criteria

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

Include criteria

1) Age <= 20 years
2) Performance status (PS) 0-2
3) Patients who underwent esophagectomy for esophageal cancer
4) Patients who were diagnosed as an anastomotic leakage within 14 days after esophagectomy
5) Written informed consent

Exclude criteria

1) Severe pneumonia and sepsis
2) Leakage at the closed stump of duodenum and jejunum
3) Repeated surgery
4) Patients requiring a limiting of the water amount
5) Patients incompatible to Abound
6) Pregnancy
7) Ineligible for the study at the physician's assessment

Related Information

• Primary Sponsor: Kodera Yasuhiro