NCT05551832

Brief Summary

This research is to determine which medication, Esmesol (PPI) or Placebo works best at reducing the chance that a patient will get an marginal ulcer after pancreaticoduodenectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

September 20, 2022

Last Update Submit

October 23, 2022

Conditions

Pancretic Dissease (Benign/Malignancy)BIle Duct Diseae(Benign/Malignancy)Ampulla of Vater Disease (Benign/Malignancy)

Outcome Measures

Primary Outcomes (1)

  • Marginal ulcer incidence

    Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers

    Time Frame: during first 6 months after surgery

Secondary Outcomes (1)

  • QOL

    Time Frame: during first 6 months after surgery

Study Arms (2)

Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months

PLACEBO COMPARATOR

Placebo beginning day of hospital discharge following PPPD for 6 months

Drug: Arm I (Placebo),

Esmesol 40mg after PPPD for 6 months

EXPERIMENTAL

Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months

Drug: Arm II (ESMESOL)

Interventions

Arm I (Placebo),DRUG

Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months

Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Arm II (ESMESOL)DRUG

SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD ,

Esmesol 40mg after PPPD for 6 months

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is age ≥ 19 years Patient meets the criteria for Open/MIS PPPD Females only: Patient is willing to take a urine pregnancy test

You may not qualify if:

  • \- Subject allergic to ESMESOL Patient receiving antifungal (i.e. ketoconazole or itraconazole) Hepatic insufficiency History of Crohns disease History of Zollinger-Ellison disease Patient received an investigational drug within 30 days of enrollment Previous Gastric Surgery HX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

JoonSeong Park

CONTACT

82-2-2019-3375JSPARK330@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 23, 2022

Study Start

October 10, 2022

Primary Completion

October 1, 2023

Study Completion

May 30, 2025

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

KR(1)