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Evaluation of the efficacy of proton pump inhibitor for postoperative delirium after hepatobiliary and pancreatic surgery

The single-center phase II study for the efficacy of proton pump inhibitor for postoperative delirium in elderly patients undergoing hepatobiliary and pancreatic surgery

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041220114
Enrollment
82
Registered
2022-12-27
Start date
2022-12-27
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

Hepatectomy or pancreatectomy for diseases of the liver, biliary tract, pancreas, and duodenum

Interventions

Proton pump inhibitor is administered from post-surgery to day 7

Sponsors

Sugiura Teiichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for elective hepatectomy or pancreatectomy for liver, biliary, pancreatic, and duodenal diseases 2.Age >= 70 years 3.Eastern Cooperative Oncology Group performance status of 0 or 1 4.Ability to undergo the Confusion Assessment Method-Intensive Care Unit (CAM-ICU) 5.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients scheduled for laparoscopic surgery. 2.Patients scheduled for hepatectomy combined with pancreatectomy. 3.Patients with dementia 4.Patients with a history of delirium 5.Patients diagnosed with psychological disorders such as alcoholism 6.Patients with habitual use of benzodiazepine receptor agonitst 7.Patients with habitual use of histamine H2-receptor antagonists within a week before registration 8.Patients with a history of hypersensitivity to proton pump inhibitor 9.Patients with habitual use of opioids or steroids 10.Patients who are determined not applicable for the study by the physician

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative delirium evaluated by the Confusion Assessment Method-Intensive Care Unit(CAM-ICU) flow sheet

Secondary

MeasureTime frame
1.The incidence of delirium diagnosed by a psychiatrist based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) 2.Duration of delirium 3.Treatment for delirium 4.The incidence of delirium according to the surgical procedure 5.The incidence of postoperative complication 6.The incidence of peptic ulcer 7.The incidence of adverse events related to proton pump inhibitor 8.Duration of the postoperative hospital stay

Contacts

Public ContactYoshiyasu Kato

Shizuoka Cancer Center

yos.kato@scchr.jp+81-55-989-5222

Outcome results

None listed

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