A study for the effect of ulinastatin for suppression of hyperamylasemia and hyperlipasemia induced by peroral double-balloon enteroscopy

UMIN ID: UMIN000000679

Registered date:01/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients who undergo peroral double-balloon enteroscopy
• Date of first enrollment: 2007/04/01
• Target sample size: 180
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

An intravenous drip injection of 150,000 U of ulinastatin dissolved in 100 ml of physiological saline for 2 hours from the start of peroral double-balloon enteroscopy
An intravenous drip injection of 100 ml of physiological saline for 2 hours from the start of peroral double-balloon enteroscopy

Outcome(s)

• Primary Outcome: serum pancreatic amylase level and serum lipase level 3 hours after and in the next morning of peroral double-balloon enteroscopy
• Secondary Outcome: presence or absence of pancreatitis after peroral double-balloon enteroscopy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) patients who have acute pancreatitis or chronic pancreatitis (2) patients with known hypersensitivity to ulinastatin (3) women who are pregnant or possible pregnant (4) patients taking endoscopy which is not aiming the insertion of endoscope deep into the small intestine

Related Information

• Primary Sponsor: Intmed3 DBE study group
• Source(s) of Monetary Support: None