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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000679
Enrollment
180
Registered
2007-10-01
Start date
2007-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who undergo peroral double-balloon enteroscopy

Interventions

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

Sponsors

Intmed3 DBE study group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who undergo peroral double-balloon enteroscopy who are 20 years of age or older, are able to understand the concerned clinical study and give written informed consent.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
serum pancreatic amylase level and serum lipase level 3 hours after and in the next morning of peroral double-balloon enteroscopy

Secondary

MeasureTime frame
presence or absence of pancreatitis after peroral double-balloon enteroscopy

Countries

Japan

Contacts

Public ContactKazuhiko Nakamura

Kyushu University Department of Medicine and Bioregulatory Science

knakamur@intmed3.med.kyushu-u.ac.jp092-642-5286

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026