Pancretic Dissease (Benign/Malignancy)Phase 3NCT05551832
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
A Phase 3 study testing Arm II (ESMESOL) in people with Pancretic Dissease (Benign/Malignancy) and BIle Duct Diseae(Benign/Malignancy), run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancretic Dissease (Benign/Malignancy), BIle Duct Diseae(Benign/Malignancy), Ampulla of Vater Disease (Benign/Malignancy)
- What is being tested?
- Arm II (ESMESOL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Oct 2022to 30 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is age ≥ 19 years Patient meets the criteria for Open/MIS PPPD Females only: Patient is willing to take a urine pregnancy test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
GangnamSeverance Hospital
Seoul
JoonSeong Park, 82-2-2019-3375, JSPARK330@yuhs.ac
About this study
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.
- Conditions
- Pancretic Dissease (Benign/Malignancy), BIle Duct Diseae(Benign/Malignancy), Ampulla of Vater Disease (Benign/Malignancy)
- Being tested
- Arm I (Placebo),, Arm II (ESMESOL)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (Placebo),Drug
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 ,
| Study group | Role | What they receive |
|---|---|---|
| Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months | Placebo comparator | Placebo beginning day of hospital discharge following PPPD for 6 months Receives: Drug: Arm I (Placebo), |
| Esmesol 40mg after PPPD for 6 months | Experimental | Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months Receives: Drug: Arm II (ESMESOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal ulcer incidence
Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers
Measured: Time Frame: during first 6 months after surgery
Secondary outcomes (1)
QOL
Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.
Measured: Time Frame: during first 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start10 Oct 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancretic Dissease (Benign/Malignancy)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Seong Park, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551832
- Sponsor's protocol ID
- 3-2022-0193
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05551832
- Acronym / sponsor ID
- 3-2022-0193
- Conditions
- Pancretic Dissease (Benign/Malignancy), BIle Duct Diseae(Benign/Malignancy), Ampulla of Vater Disease (Benign/Malignancy)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
| Arm | Type | Receives |
|---|---|---|
| Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months | Placebo comparator | Drug: Arm I (Placebo),Placebo beginning day of hospital discharge following PPPD for 6 months |
| Esmesol 40mg after PPPD for 6 months | Experimental | Drug: Arm II (ESMESOL)Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject is age ≥ 19 years Patient meets the criteria for Open/MIS PPPD Females only: Patient is willing to take a urine pregnancy test
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm I (Placebo),Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months | Drug | Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months |
| Arm II (ESMESOL)SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD , | Drug | Esmesol 40mg after PPPD for 6 months |
Primary outcome
Marginal ulcer incidence
Time frame: Time Frame: during first 6 months after surgery
Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers
1 secondary outcome
QOL
Time frame: Time Frame: during first 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arm II (ESMESOL) in people with Pancretic Dissease (Benign/Malignancy) and BIle Duct Diseae(Benign/Malignancy), run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JoonSeong Park (82-2-2019-3375, JSPARK330@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal ulcer incidence (time frame: Time Frame: during first 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.