A phase II randomized controlled trial on effect of digestive enzymes for the development of nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy.

A phase II randomized controlled trial on effect of digestive enzymes for the development of nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy. - A phase II randomized controlled trial on effect of digestive enzymes for the development of nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017266

Enrollment

100

Registered

2015-04-24

Start date

2015-04-27

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 need pancreaticoduodenectomy

Interventions

Control group: Oral administration of conventional digestive enzyme (common dosage) after pancreraticoduodenectomy Test group: Oral administration of high potent digestive enzyme (common dosage) after

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Planned to undergo pancreaticoduodenectomy R0 or R1 operation Sufficient oral intake at one month after surgery Adequate organ function Written informed consent

Exclusion criteria

Exclusion criteria: Preoperative fatty liver Positive HBs antigen or HCV antibody alcohol abuse total pancreatectomy R2 operation Gastrointestinal disease with malabsorption Other reason that attending doctors consider

Design outcomes

Primary

Measure	Time frame
The incidence of non alcoholic fatty liver disease one year after surgery	—

Secondary

Measure	Time frame
The nutritional status, pancreatic endocrine and exocrine function one year after surgery	—

Countries

Japan

Contacts

Public ContactMakoto Nishikawa

National Defense Medical College Department of Surgery

nishikawa@ndmc.ac.jp042-995-1211

Outcome results

None listed

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