![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000040641 |
Receipt No. | R000046386 |
Scientific Title | Vonoprazan or Proton-pump inhibitor for gastric endoscopic submucosal dissection in patients under antithrombotic therapy: a randomized prospective multicenter study |
Date of disclosure of the study information | 2020/06/03 |
Last modified on | 2020/12/03 |
Basic information | ||
Public title | Vonoprazan or Proton-pump inhibitor for gastric endoscopic submucosal dissection in patients under antithrombotic therapy: a randomized prospective multicenter study | |
Acronym | V-POINT study | |
Scientific Title | Vonoprazan or Proton-pump inhibitor for gastric endoscopic submucosal dissection in patients under antithrombotic therapy: a randomized prospective multicenter study | |
Scientific Title:Acronym | V-POINT study | |
Region |
|
Condition | ||
Condition | gastric epithelial neoplasms | |
Classification by specialty |
|
|
Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to prospectively assess the superiority of vonoprazan over classical proton pump inhibitors regarding the risk of delayed bleeding after gastric endoscopic submucosal dissection in patients under antithrombotic therapy. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Incidence of bleeding within 8 weeks after ESD. |
Key secondary outcomes | 1. Frequency of GERD-like symptoms after ESD.
2. Frequency of pain after ESD. 3. Healing of the ulcer at 8 weeks after ESD. 4. Adverse events related to ESD. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | Patients will be randomly allocated to either VPZ or PPI group. In the PPI group, esomeprazole 20mg will be administered orally from the day before ESD to 54 days after ESD. | |
Interventions/Control_2 | VPZ 20mg will be administered orally from the day before ESD to 54 days after ESD. | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1. Gastric adenoma or early gastric cancer.
condition of early gastric cancer: 1) 2cm or smaller cT1a, well diff. UL0 2) larger than 2cm, cT1a, well diff.UL0 3) 3cm or smaller, cT1a, well diff. UL1 4) 2cm or smaller, cT1a, undiff. UL0 2. age 20 or older 3. PS=0,1,2 4. Laboratory data: Hb 9g/dl or larger Plt 100,000/mm3 or larger AST, ALT 100 1U/l or less PT-INR 80% or larger 5. Could be followed up for 56 days after ESD. 6. Those who gave written consent. |
|||
Key exclusion criteria | 1. Those with simultaneous esophageal or duodenal endoscopic treatment.
2. Endoscopic treatment for upper digestive tract within 31 days before ESD. 3. Women with pregnancy, 4. Psychological disorders. 5. Presence of active infectious diseases. 6. Impossible to answer to F-Scale or VAS. 7. Allergy to VPZ or EPZ. |
|||
Target sample size | 210 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Nagoya University | ||||||
Division name | Department of Gastroenterology & Hepatology, Nagoya University Graduate School of Medicine | ||||||
Zip code | 466-8550 | ||||||
Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Japan | ||||||
TEL | +81-52-744-2164 | ||||||
mtfujish@gmail.com |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Nagoya University | ||||||
Division name | Department of Gastroenterology & Hepatology, Nagoya University Graduate School of Medicine | ||||||
Zip code | 466-8550 | ||||||
Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Japan | ||||||
TEL | +81-52-744-2164 | ||||||
Homepage URL | |||||||
kakushin-tky@umin.ac.jp |
Sponsor | |
Institute | Nagoya University |
Institute | |
Department |
Funding Source | |
Organization | No funding source. |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Nagoya University Graduate School of Medicine, IRB |
Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Japan |
Tel | +81-052-744-2973 |
ethics@med.nagoya-u.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 山下病院(愛知県)、名鉄病院(愛知県)、刈谷豊田総合病院(愛知県)、
江南厚生病院(愛知県)、半田市立半田病院(愛知県)、名古屋第一赤十字病院(愛知県) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046386 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |