Phase II randomized clinical trial for the purpose of examining the protective efficacy of the non-alcoholic fatty liver development by pancrelipase preparation being given for pancreatic cancer patients who underwent pancreaticoduodenectomy or total pancreatectomy.

Phase II randomized clinical trial for the purpose of examining the protective efficacy of the non-alcoholic fatty liver development by pancrelipase preparation being given for pancreatic cancer patients who underwent pancreaticoduodenectomy or total pancreatectomy. - Phase II randomized clinical trial about the non-alcoholic fatty liver development prevention with the pancrelipase preparation administration

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019817

Enrollment

Registered

2015-11-17

Start date

2011-11-29

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

To assume the decreased rate of post-operative non-alcoholic fatty liver incidence in pancreatic cancer patients with the prophylactic administration of the pancrelipase preparation.

Interventions

Intervention group: Administration of Pancrelipase capsule with standard dose. Control group: conventional administration of digestive enzymes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patients with pancreatic cancerwho underwent pancreaticoduodenectomy (PD) or total pancreatectomy (TP) for pancreatic cancer. The patients that the agreement was obtained in a document

Exclusion criteria

Exclusion criteria: 1 The patients who had a diagnosis of non alcoholic fatty liver by perioperative liver biopsy 2 The patients who cannot do initiation of the pancrelipase preparation even if it passes for two months after surgery 3 Alcohol common custom drinking career after surgery 4 Severe obesity BMI>30 5 The patients with the persistent infection of the hepatitis virus 6 The patients who receive steroid treatment 7 The patients with the preoperative fatty liver 8 patients with the allergy to swine protein or digestive enzymes preparation 9 The patients with a grave cardiovascular system, a respiratory system, a digestive system, an urinary system or a mind, the neurological disease 10 The patients with a history of the drug abuse 11 During the pregnancy or the patients nursing and the patients who may be pregnant 12 Patients with acute pancreatitis and patients with bowel obstruction 13 the patients of the acute advanced stage in patients with chronic pancreatitis 14 The patients with the factor that may affect other treatment outcomes and the patients who judged it when a clinical trial responsibility doctor or a clinical trial allotment doctor should not participate in a clinical trial 15 The patients who cannot do it of the self judgment

Design outcomes

Primary

Measure	Time frame
Incidence of post-opearative non-alcoholic fatty liver disease (within i year after PD)	—

Countries

Japan

Contacts

Public ContactSohei SATOI MD

Kansai Medical University Department of Surgery

satoi@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

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