Comparison of ESD outcome using different dose of PPI

Comparison of clinical outcomes after endoscopic submucosal dissection using high versus standard dose proton pump inhibitor : A prospective, randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004239

Enrollment

438

Registered

2019-08-26

Start date

2018-07-17

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

None listed

Interventions

Drug : This study was conducted to evaluate the optimal dose of PPI in terms of minimizing bleeding and pain after ESD. High dose PPI group received parenteral esomeprazole (Nexium

AstraZeneka Korea, Seoul, Korea) with an 80 mg loading dose over 5 min followed by intravenous infusion for 48 hours with 8mg/hour rate. On the other hand, standard dose PPI group received single dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Over 19 years old patients who planned to undergo endoscopic submucosal dissection for gastric adenoma or early gastric caner. 2) Person who are agreed upon study enrollement.

Exclusion criteria

Exclusion criteria: 1) Coagulopathy defined by Prothrombine time > 1.5 INR, activated partial thromboplastin time > 1.5 times above reference value 2) Previous history of stomach surgery 3) Allergic to PPI (Hypersensitivity or history of hypersensitivity to PPI itself, constituent of PPI or Benzimidazole) 4) Pregnant or lactating woman 5) If it is impossible to assess one's pain 6) Patients using atazanavir or nelfinavir 7) Patients using Rilpivirine-containing medication

Design outcomes

Primary

Measure	Time frame
Delayed bleeding	—

Secondary

Measure	Time frame
Severity of post procedural pain	—

Countries

Korea, Republic of

Contacts

Public ContactYoo Min Park

Kyung Hee University Hospital

uminee@naver.com+82-2-958-8150

Outcome results