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Comparison of pancrelipase and pancreatin for treatment of patients with pancreatic exocrine insufficiency due to pancreatic resection

Comparison of pancrelipase and pancreatin for treatment of patients with pancreatic exocrine insufficiency due to pancreatic resection - Pancrelipase vs. Pancreatin for treatment of pancreatc exocrine insufficiency due to pancreatic resection (PEC trial)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009816
Enrollment
62
Registered
2013-01-20
Start date
2013-01-01
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 will undergo pancreatectomy

Interventions

Pancrelipase group: 600mg of pancrelipase to be taken three times a day (1800mg /day) after meals for 24weeks. Pancreatin group: One gram of pancreatin to be taken three times a day (3g /day) after

Sponsors

Chiba University, Graduate School of Medicine, Department of General Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who are scheduled to undergo pancreticoduodenectomy or distal pancreatectomy or total pancreatectomy 2)No prior therapy of pancreatic surgery 3)Written informed consent. 4)Age of at least 20 years old at the time of registration. 5)Performance status of 0 or 1.

Exclusion criteria

Exclusion criteria: 1)Case with possibility of pregnancy or during nursing 2)Sever infection 3)Malabsorption syndrome without pancreatic disease 4)Alegyin porcine or bovine protein or digestive enzym 5)Participates in other examinations of pancreatic exocrine insufficiency. 6)The case judged to be inappropriate for the examination to carry out this study safely by attending doctor

Design outcomes

Primary

MeasureTime frame
Increased level of serum albumin after treatment for 24 weeks compared with preoperative level.

Secondary

MeasureTime frame
1)nutrient assessment 2)condition of stool 3)Body composition(%) 4)edema

Countries

Japan

Contacts

Public ContactHideyuki Yoshitomi

Chiba University Hospital Hepatobiliary Pancreatic Surgery

yoshitomi@faculty.chiba-u.jp043-222-7171

Outcome results

None listed

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