Study test for development of comprehensive improvement of QOL by ghrelin in cancer treatment-Phase I/II clinical trial regarding clinical effect by ghrelin administration in patients who undergo hepato-biliary-pancreas surgery-

Study test for development of comprehensive improvement of QOL by ghrelin in cancer treatment-Phase I/II clinical trial regarding clinical effect by ghrelin administration in patients who undergo hepato-biliary-pancreas surgery- - Phase I/II clinical trial regarding clinical effect by ghrelin administration in patients who undergo hepato-biliary-pancreas surgery

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008908

Enrollment

Registered

2012-09-25

Start date

2012-10-01

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

Malignant tumor in hepato-biliary-pancreas

Interventions

Prospective randomized, placebo-controlled clinical trial assigned a total of 40 patients with hepato-biliary-pancreas maligancies who undergo radical surgery, into either ghrelin (n=20) or placebo gr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Informed consent and agreement by patient of enrolling the present study 2.Age between 20-80 years old 3.Radical surgery for hepato-biliary-pancreas malignancies is achieved. 4.Poorly oral intake and malnutrition at 6 months after operation for hepato-biliary-pancreas surgery 5. Oral intake possible

Exclusion criteria

Exclusion criteria: 1.Existence of serious co-morbidity or active multiple cancer 2.Judged as inadequate by project owner 3.Existence of serious liver (AST, ALT over double of upper limit of normal range) and kidney (creatinine over 2.0mg/dl) dysfunctions

Design outcomes

Primary

Measure	Time frame
Postoperative morbidity, Post-administration side effect of ghrelin	—

Secondary

Measure	Time frame
calorie intake after meal, nutritional assessment	—

Countries

Japan

Contacts

Public ContactAtsushi Nanashima

Nagasaki University Graduate School of Biomedical Sciences Division of Surgical Oncology and Department of Surgery

a-nanasm@alpha.med.nagasaki-u.ac.jp+81-095-819-7304

Outcome results

None listed

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