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Stomach NeoplasmsNCT02730533

The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

A study testing Esomeprazole and No PPI treatment in people with Stomach Neoplasms, run by Xijing Hospital of Digestive Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stomach Neoplasms
What is being tested?
Esomeprazole and No PPI treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteChina
Study dates
Mar 2016to Apr 2017
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and the willingness to sign a written informed consent document.
  • Female or male aged ≥18 years.
  • Patients must have gastric mucosal lesion that are eligible for ESD indications (Japanese Gastric Cancer Association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy.

Who cannot join

  • Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
  • The ASA classification of physical status ≥ 4 as judged by the investigator.
  • Severe hepatic disease or renal disease
  • Ability to understand and the willingness to sign a written informed consent document.
  • Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
  • Haemorrhagic disorder.
Show all 14Show fewer
  • Patients who had a history of gastrectomy or a recurrent lesion.
  • Known or suspected hypersensitivity to any component of any PPI .
  • Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
  • Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
  • Known or suspected alcohol, drug or medication abuse.
  • Any condition associated with poor compliance as judged by the investigator.
  • Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
  • Involvement in the planning and conduct of the study. Previous enrollment in the present study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital of Digestive Diseases

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD: an Endoscopist-blinded Randomized Controlled Study

This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal lesions.

Being tested
Esomeprazole, No PPI treatment
Keywords
endoscopic submucosal dissection, proton pump inhibitor, bleeding
Medical subject headings
Stomach Neoplasms, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsomeprazoleDrug

    Proton pump inhibitor

  • No PPI treatmentDrug

    No PPI treatment before ESD procedure

Study groups in NCT02730533
Study groupRoleWhat they receive
Control groupActive comparatorNo PPI treatment should given after the initial allocation. Patient will be admitted, and ESD will be performed. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg.
Receives: Drug: No PPI treatment
Esomeprazole groupExperimentalEsomeprazole should start as soon as possible after the initial allocation. During the 7 days of p.o. treatment, patient will be admitted, and ESD will be performed as soon as completing the p.o. treatment. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg.
Receives: Drug: Esomeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The total bleeding rate according to grading of intraoperative bleeding during ESD procedure

    ≥grade 1 means bleeding

    Measured: 1 day

Secondary outcomes (6)

  1. The frequency of coagrasper usage which reflects grade of major bleeding

    Measured: 1 day

  2. Post-ESD ulcer quality as indicated in description

    Ulcer base quality will be evaluated base on the grading of clean, with minor trace of coagulation, base with extensive coagulation.

    Measured: 1 day

  3. Intra-procedure injury to muscularis propria including perforation.

    Injury of muscularis propria will be evaluated as no injury, minor injury and deep injury/perforation.

    Measured: 1 day

  4. Mean haemoglobin reduction between intervention and control group.

    Measured: 1 day

  5. Delayed bleeding rate as indicated by haematemesis and melaena

    Measured: 30 days

  6. The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMar 2017
  4. Study completionApr 2017

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730533
Sponsor's protocol ID
KY20162024-1
Status last verified
Jul 2017
First submitted
28 Mar 2016
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Paper publishing

Publications

  • Ahn JY, Jung HY, Choi KD, Choi JY, Kim MY, Lee JH, Choi KS, Kim DH, Song HJ, Lee GH, Kim JH, Park YS. Endoscopic and oncologic outcomes after endoscopic resection for early gastric cancer: 1370 cases of absolute and extended indications. Gastrointest Endosc. 2011 Sep;74(3):485-93. doi: 10.1016/j.gie.2011.04.038. Epub 2011 Jul 13.

    PubMed 21741645

  • Choi MK, Kim GH, Park DY, Song GA, Kim DU, Ryu DY, Lee BE, Cheong JH, Cho M. Long-term outcomes of endoscopic submucosal dissection for early gastric cancer: a single-center experience. Surg Endosc. 2013 Nov;27(11):4250-8. doi: 10.1007/s00464-013-3030-4. Epub 2013 Jun 14.

    PubMed 23765426

  • Deprez PH, Bergman JJ, Meisner S, Ponchon T, Repici A, Dinis-Ribeiro M, Haringsma J. Current practice with endoscopic submucosal dissection in Europe: position statement from a panel of experts. Endoscopy. 2010 Oct;42(10):853-8. doi: 10.1055/s-0030-1255563. Epub 2010 Jul 9.

    PubMed 20623442

  • Fujishiro M, Chiu PW, Wang HP. Role of antisecretory agents for gastric endoscopic submucosal dissection. Dig Endosc. 2013 Mar;25 Suppl 1:86-93. doi: 10.1111/j.1443-1661.2012.01370.x. Epub 2013 Jan 24.

    PubMed 23368844

  • Gotoda T, Kondo H, Ono H, Saito Y, Yamaguchi H, Saito D, Yokota T. A new endoscopic mucosal resection procedure using an insulation-tipped electrosurgical knife for rectal flat lesions: report of two cases. Gastrointest Endosc. 1999 Oct;50(4):560-3. doi: 10.1016/s0016-5107(99)70084-2. No abstract available.

    PubMed 10502182

  • Jang JS, Choi SR, Graham DY, Kwon HC, Kim MC, Jeong JS, Won JJ, Han SY, Noh MH, Lee JH, Lee SW, Baek YH, Kim MJ, Jeong DS, Kim SK. Risk factors for immediate and delayed bleeding associated with endoscopic submucosal dissection of gastric neoplastic lesions. Scand J Gastroenterol. 2009;44(11):1370-6. doi: 10.3109/00365520903194609.

    PubMed 19891589

Questions about this trial

What is this clinical trial studying?

A study testing Esomeprazole and No PPI treatment in people with Stomach Neoplasms, run by Xijing Hospital of Digestive Diseases at 1 site in China.

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 3 inclusion and 14 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: finished, as of the sponsor's last update on 21 Jul 2017. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The total bleeding rate according to grading of intraoperative bleeding during ESD procedure (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02730533, which also lists 6 linked publications.

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 21 Jul 2017.

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