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AzTrials

Gastric NeoplasmsPhase 3SLEGDNCT02005809

Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm

A Phase 3 study testing second look endoscopy in people with Gastric Neoplasms, run by Kosin University Gospel Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gastroenterologists often follow up second look endoscopy after endoscopic submucosal dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure sites. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Gastric Neoplasms
What is being tested?
second look endoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
1 siteSouth Korea
Study dates
Mar 2013to Mar 2015
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 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histological confirmed patients(gastric adenoma or adenocarcinoma)
  • performed gastric ESD patients about 24 hours before

Who cannot join

  • perforation after ESD
  • piecemeal resection of ESD specimen
  • hemostatic agent or proton pump inhibitor users before ESD
  • heparin or antiplatelet agent users
  • Serious concurrent infection or nonmalignant illness that is uncontrolled
  • Psychiatric disorder that would preclude compliance
  • Allergy history to proton pump inhibitor

Trial locations and contacts

1 site in 1 country.

Moo In Park, MD contact

82519905061

myjuyoung@hanmail.net

South Korea1 site, 1 recruiting

  • Kosin University Gospel Hospital

    Busan, 602-702

    KiHwan Ku, MD, 82519905209, lci7ku@naver.com

    Recruiting

Other trials in South Korea

About this study

Gastroenterologists often follow up second look endoscopy after endoscopic submucosal dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure sites. But Goto suggested in his retrospective analysis that a second-look endoscopy after endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary. So, the investigators try to identify the hypothesis prospectively in this study.

Being tested
second look endoscopy
Keywords
Endoscopic submucosal dissection, gastric neoplasm, second look endoscopy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • second look endoscopyProcedure or surgery

    Second look endoscopy includes observation or prophylactic bleeding control of ESD site.

Study groups in NCT02005809
Study groupRoleWhat they receive
Second look endoscopyActive comparatorThis group is performed second look endoscopy about 24 hours later from endoscopic submucosal dissection.
Receives: Procedure: second look endoscopy
without second look endoscopyNo interventionThis group is not performed second look endoscopy after ESD

What is being measured

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

  1. Post-ESD bleeding rate according to second look endoscopy

    Measured: Up to 60days

Secondary outcomes (4)

  1. bleeding complication rate according to location of lesion in stomach.

    Fundus, cardia, upper body, mid body, lower body, antrum anterior wall, posterior wall, great curvature, lesser curvature

    Measured: Up to 60days

  2. Bleeding rate according to size of resected specimen

    longest diameter of specimen: millimeter

    Measured: Up to 60days

  3. Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection

    Measured: Up to 60days

  4. Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection

    Mild: bleeding control time: <1/3 of total ESD procedure time. Moderate: bleeding control time: 1/3~1/2 of total ESD procedure time Severe: bleeding control time: >1/2 of total ESD procedure time

    Measured: Up to 60days

Timeline

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

  1. First posted9 Dec 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2015 (estimated)
  4. Study completionMar 2015 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02005809
Sponsor's protocol ID
2nd look EGD
Acronym
SLEGD
Status last verified
Dec 2013
First submitted
26 Nov 2013
Last updated
9 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Ohkuwa M, Hosokawa K, Boku N, Ohtu A, Tajiri H, Yoshida S. New endoscopic treatment for intramucosal gastric tumors using an insulated-tip diathermic knife. Endoscopy. 2001 Mar;33(3):221-6. doi: 10.1055/s-2001-12805.

    PubMed 11293753

  • Takeshita K, Tani M, Inoue H, Saeki I, Honda T, Kando F, Saito N, Endo M. A new method of endoscopic mucosal resection of neoplastic lesions in the stomach: its technical features and results. Hepatogastroenterology. 1997 Nov-Dec;44(18):1602-11.

    PubMed 9427030

  • Goto O, Fujishiro M, Kodashima S, Ono S, Niimi K, Hirano K, Yamamichi N, Koike K. A second-look endoscopy after endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary: a retrospective analysis of postendoscopic submucosal dissection bleeding. Gastrointest Endosc. 2010 Feb;71(2):241-8. doi: 10.1016/j.gie.2009.08.030. Epub 2009 Nov 17.

    PubMed 19922919

  • Tsuji Y, Ohata K, Ito T, Chiba H, Ohya T, Gunji T, Matsuhashi N. Risk factors for bleeding after endoscopic submucosal dissection for gastric lesions. World J Gastroenterol. 2010 Jun 21;16(23):2913-7. doi: 10.3748/wjg.v16.i23.2913.

    PubMed 20556838

  • Takizawa K, Oda I, Gotoda T, Yokoi C, Matsuda T, Saito Y, Saito D, Ono H. Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection--an analysis of risk factors. Endoscopy. 2008 Mar;40(3):179-83. doi: 10.1055/s-2007-995530.

    PubMed 18322872

  • Kim JW, Kim HS, Park DH, Park YS, Jee MG, Baik SK, Kwon SO, Lee DK. Risk factors for delayed postendoscopic mucosal resection hemorrhage in patients with gastric tumor. Eur J Gastroenterol Hepatol. 2007 May;19(5):409-15. doi: 10.1097/MEG.0b013e32801015be.

    PubMed 17413293

  • Uedo N, Takeuchi Y, Yamada T, Ishihara R, Ogiyama H, Yamamoto S, Kato M, Tatsumi K, Masuda E, Tamai C, Yamamoto S, Higashino K, Iishi H, Tatsuta M. Effect of a proton pump inhibitor or an H2-receptor antagonist on prevention of bleeding from ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial. Am J Gastroenterol. 2007 Aug;102(8):1610-6. doi: 10.1111/j.1572-0241.2007.01197.x. Epub 2007 Mar 31.

    PubMed 17403076

  • Chung IK, Lee JH, Lee SH, Kim SJ, Cho JY, Cho WY, Hwangbo Y, Keum BR, Park JJ, Chun HJ, Kim HJ, Kim JJ, Ji SR, Seol SY. Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study. Gastrointest Endosc. 2009 Jun;69(7):1228-35. doi: 10.1016/j.gie.2008.09.027. Epub 2009 Feb 27.

    PubMed 19249769

  • Gotoda T, Yanagisawa A, Sasako M, Ono H, Nakanishi Y, Shimoda T, Kato Y. Incidence of lymph node metastasis from early gastric cancer: estimation with a large number of cases at two large centers. Gastric Cancer. 2000 Dec;3(4):219-225. doi: 10.1007/pl00011720.

    PubMed 11984739

  • Ono H, Kondo H, Gotoda T, Shirao K, Yamaguchi H, Saito D, Hosokawa K, Shimoda T, Yoshida S. Endoscopic mucosal resection for treatment of early gastric cancer. Gut. 2001 Feb;48(2):225-9. doi: 10.1136/gut.48.2.225.

    PubMed 11156645

  • Fujishiro M, Kodashima S, Goto O, Ono S, Muraki Y, Kakushima N, Omata M. Technical feasibility of endoscopic submucosal dissection of gastrointestinal epithelial neoplasms with a splash-needle. Surg Laparosc Endosc Percutan Tech. 2008 Dec;18(6):592-7. doi: 10.1097/SLE.0b013e318187973f.

    PubMed 19098667

  • Shimatani T, Inoue M, Kuroiwa T, Xu J, Tazuma S, Horikawa Y, Nakamura M. Acid-suppressive efficacy of a reduced dosage of rabeprazole: comparison of 10 mg twice daily rabeprazole with 20 mg twice daily rabeprazole, 30 mg twice daily lansoprazole, and 20 mg twice daily omeprazole by 24-hr intragastric pH-metry. Dig Dis Sci. 2005 Jul;50(7):1202-6. doi: 10.1007/s10620-005-2760-0.

    PubMed 16047460

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing second look endoscopy in people with Gastric Neoplasms, run by Kosin University Gospel 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 2 inclusion and 7 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 9 Dec 2013. 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. 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 Moo In Park, MD (82519905061, myjuyoung@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-ESD bleeding rate according to second look endoscopy (time frame: Up to 60days). 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 NCT02005809, which also lists 12 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 9 Dec 2013.

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