A study comparing two acid-suppressing medications (PPI and P-CAB) to prevent ulcers that may occur after pancreaticoduodenectomy

A Prospective, Randomized, Controlled Trial Comparing Proton Pump Inhibitors versus Potassium-competitive Acid Blockers for the Prevention of Marginal Ulcers after Pancreaticoduodenectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0011216

Enrollment

290

Registered

2025-11-25

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : To prevent ulcers that may occur after pancreaticoduodenectomy, participants will begin the two acid-suppressing medications as soon as they are able to take oral intake.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Adults aged 19 years or older. ? Patients who recently underwent pancreaticoduodenectomy. ? Patients who can initiate the study medication as soon as oral intake becomes possible after surgery. ? No contraindications to acid-suppressing therapy and able to take medications orally. ? Able to comply with study visit schedules, including planned upper endoscopy at 4 and 12 weeks, and additional unplanned upper endoscopy if needed. ? No clinically suspected or confirmed active upper gastrointestinal bleeding or ulcers requiring immediate treatment at the time of randomization.

Exclusion criteria

Exclusion criteria: ?Confirmed active upper gastrointestinal bleeding or ulcers requiring treatment immediately before randomization/administration. ?History of contraindication or severe hypersensitivity to study drug components (lansoprazole, tegoprazan, or excipients). ?Expected inability to take oral medication for more than 14 days, or inability to undergo the planned upper endoscopies at 4 and 12 weeks (e.g., contraindication or refusal). ?Pregnant or breastfeeding women, or women of childbearing potential unwilling or unable to comply with contraception requirements. ?Participation in another interventional clinical trial or exposure to an investigational product (drug/device) within the past 30 days. ?Severe hepatic impairment (e.g., Child–Pugh Class C) or advanced liver disease that may interfere with safe drug administration. ?Presence of significant drug–drug interactions that cannot be appropriately managed or adjusted.

Design outcomes

Primary

Measure	Time frame
Occurrence of the first marginal ulcer within 12 weeks after surgery.	—

Secondary

Measure	Time frame
Endoscopic ulcers or ulcer-related findings.	—

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

britnepak@outlook.com+82-31-8086-2858

Outcome results