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Bleeding at Gastric CancerPhase 2NCT02732483

Role of Hemostatic Powder (Endo-clotTM) in Success and Prevention of Bleeding Within Gastric Cancer Patients With Bleeding

A Phase 2 study testing Endo-Clot(TM) in people with Bleeding at Gastric Cancer, run by Yonsei University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed, controlling GI hemorrhage in gastric cancer is much easier these days. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Bleeding at Gastric Cancer
What is being tested?
Endo-Clot(TM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
Apr 2016to Apr 2018
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 19 and less 80 yeas old
  • Gastric cancer was diagnosed with biopsy and/or computed tomography
  • Endoscopic hemostasis is needed upto GI hemorrhage
  • Endoscopic examination is available in 24hours
  • ECOG performance status(PS) <2

Who cannot join

  • Double primary caner
  • Hypersensitivity of hemostatic power[Endo-Clot(TM)]
  • Variceal bleeding or benign gastric ulcer bleeding
  • Hemodynamically unstable with low systolic BP<90mmHg and/or tachycardia PR>120bpm
  • endoscopic hemostasis within 7 days before screening
  • Contraindication for endoscopic examination
Show all 18Show fewer
  • Pregnant
  • Breast feeding
  • bleeding tendency with low platelet count <50,000 /mm^3 and/or INR>2
  • Bacterial infection with needs for antibiotics therapy
  • Unavailable to discontinue anti-coagulation agent for 3days
  • Vascular shunt
  • Cardiovascular and/or pulmonary diseases
  • Active hepatitis or severe liver diseases
  • Renal dysfunction
  • Bone marrow dysfunction
  • Neurologic deficit and/or psychotic feature
  • Unavailable informed consent

Trial locations and contacts

1 site in 1 country.

Jun Chul Park, MD contact

+ 82-2-2228-2272

JUNCHUL75@yuhs.ac

South Korea1 site

  • Department of Internal Medicine,

    Seoul, Seoul, 03722

    Jun Chul Park, MD, + 82-2-2228-2272, JUNCHUL75@yuhs.ac

Other trials in South Korea

About this study

Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed, controlling GI hemorrhage in gastric cancer is much easier these days. but re-bleeding rate is still high, even after successful hemostasis with APC or electrical coagulation. Furthermore patients who were experienced re-bleeding are expected poorer survival outcomes than those who are not. So excellent bleeding control in gastric cancer is most important in GI hemorrhage of gastric cancer.

Recently developed hemostatic powder [Endo-Clot(TM)] is easy to use and have proven its usefulness in GI hemorrhage in peptic ulcer diseases. So in this study, investigator will try to find out feasibility \& safety of Endo-Clot(TM) in GI hemorrhage in gastric cancer.

Being tested
Endo-Clot(TM)
Keywords
gastric cancer, bleeding, gastrointestinal hemorrhage
Medical subject headings
Stomach Neoplasms, Hemorrhage, Gastrointestinal Hemorrhage

What participants receive

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

  • Endo-Clot(TM)Drug

    The patients agreed in this study, bleeding control will going to be done with Endo-Clot(TM)

Study groups in NCT02732483
Study groupRoleWhat they receive
Endo-Clot(TM)ExperimentalNot described
Receives: Drug: Endo-Clot(TM)

What is being measured

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

  1. Rebleeding rate

    Proportion of patients who are experience rebleeding events after hemostasis within 30 days expected to be lower than 10 %.

    Definition rebleeding events 1. Overt symptoms of GI bleeding(such as hematemesis, melena) and/or Hemoglobin down more than 2g/dl compared to Hemoglobin level which were checked just after procedure.

    Measured: within 30 days

Secondary outcomes (4)

  1. Success of bleeding control rate

    Proportion of patients who are experience successful hemostasis is expected to be higher than 80 %applying Endo-Clot™, Rebleeding rate in 3days, rate of additional intervention other than initial endoscopic hemostasis, Mortalities

    Measured: within 2 weeks and 4 weeks

  2. Rebleeding rate

    Proportion of patients experience rebleeding events after hemostasis within 3 days expected to be lower than 5 %. Definition of Rebleeding rate in 3days 1. Overt symptoms of GI bleeding(such as hematemesis, melena) and/or Hemoglobin down more than 2g/dl compared to Hemoglobin level which were checked just after procedure.

    Measured: in 3 days

  3. Rate of additional intervention other than initial endoscopic hemostasis

    Definition of Successful hemostasis; controlled bleeding vessel in 5 minute after applying Endo-Clot™

    Measured: within 2 weeks to 4 weeks

  4. Mortalities

    Measured: within 2 weeks to 4 weeks

Timeline

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

  1. First posted8 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2018 (estimated)
  4. Study completionApr 2018 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02732483
Sponsor's protocol ID
4-2016-0031
Status last verified
Apr 2016
First submitted
27 Mar 2016
Last updated
8 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: no plan to share data

Publications

  • Thrumurthy SG, Chaudry MA, Hochhauser D, Mughal M. The diagnosis and management of gastric cancer. BMJ. 2013 Nov 4;347:f6367. doi: 10.1136/bmj.f6367. No abstract available.

    PubMed 24191271

  • Chaw CL, Niblock PG, Chaw CS, Adamson DJ. The role of palliative radiotherapy for haemostasis in unresectable gastric cancer: a single-institution experience. Ecancermedicalscience. 2014 Jan 10;8:384. doi: 10.3332/ecancer.2014.384. eCollection 2014.

    PubMed 24482669

  • Lee HJ, Yang HK, Ahn YO. Gastric cancer in Korea. Gastric Cancer. 2002;5(3):177-82. doi: 10.1007/s101200200031. No abstract available.

    PubMed 12378346

  • Isobe Y, Nashimoto A, Akazawa K, Oda I, Hayashi K, Miyashiro I, Katai H, Tsujitani S, Kodera Y, Seto Y, Kaminishi M. Gastric cancer treatment in Japan: 2008 annual report of the JGCA nationwide registry. Gastric Cancer. 2011 Oct;14(4):301-16. doi: 10.1007/s10120-011-0085-6. Epub 2011 Sep 7.

    PubMed 21894577

  • Lasithiotakis K, Antoniou SA, Antoniou GA, Kaklamanos I, Zoras O. Gastrectomy for stage IV gastric cancer. a systematic review and meta-analysis. Anticancer Res. 2014 May;34(5):2079-85.

    PubMed 24778009

  • Romera Barba E, Castaner Ramon-Llin J, Sanchez Perez A, Garcia Marcilla JA, Vazquez Rojas JL. Transcatheter arterial embolization in the management of acute bleeding from advanced gastric cancer. Cir Esp. 2014 Aug-Sep;92(7):492-4. doi: 10.1016/j.ciresp.2013.11.004. Epub 2013 Dec 27. No abstract available. English, Spanish.

    PubMed 24378191

  • Sheibani S, Kim JJ, Chen B, Park S, Saberi B, Keyashian K, Buxbaum J, Laine L. Natural history of acute upper GI bleeding due to tumours: short-term success and long-term recurrence with or without endoscopic therapy. Aliment Pharmacol Ther. 2013 Jul;38(2):144-50. doi: 10.1111/apt.12347. Epub 2013 May 28.

    PubMed 23710797

  • Kim YI, Choi IJ, Cho SJ, Lee JY, Kim CG, Kim MJ, Ryu KW, Kim YW, Park YI. Outcome of endoscopic therapy for cancer bleeding in patients with unresectable gastric cancer. J Gastroenterol Hepatol. 2013 Sep;28(9):1489-95. doi: 10.1111/jgh.12262.

    PubMed 23662891

  • Kim MM, Rana V, Janjan NA, Das P, Phan AT, Delclos ME, Mansfield PF, Ajani JA, Crane CH, Krishnan S. Clinical benefit of palliative radiation therapy in advanced gastric cancer. Acta Oncol. 2008;47(3):421-7. doi: 10.1080/02841860701621233.

    PubMed 17899453

  • Hashimoto K, Mayahara H, Takashima A, Nakajima TE, Kato K, Hamaguchi T, Ito Y, Yamada Y, Kagami Y, Itami J, Shimada Y. Palliative radiation therapy for hemorrhage of unresectable gastric cancer: a single institute experience. J Cancer Res Clin Oncol. 2009 Aug;135(8):1117-23. doi: 10.1007/s00432-009-0553-0. Epub 2009 Feb 10.

    PubMed 19205735

  • Asakura H, Hashimoto T, Harada H, Mizumoto M, Furutani K, Hasuike N, Matsuoka M, Ono H, Boku N, Nishimura T. Palliative radiotherapy for bleeding from advanced gastric cancer: is a schedule of 30 Gy in 10 fractions adequate? J Cancer Res Clin Oncol. 2011 Jan;137(1):125-30. doi: 10.1007/s00432-010-0866-z. Epub 2010 Mar 25.

    PubMed 20336314

  • Tey J, Choo BA, Leong CN, Loy EY, Wong LC, Lim K, Lu JJ, Koh WY. Clinical outcome of palliative radiotherapy for locally advanced symptomatic gastric cancer in the modern era. Medicine (Baltimore). 2014 Nov;93(22):e118. doi: 10.1097/MD.0000000000000118.

    PubMed 25396330

  • Ono S, Ono M, Nakagawa M, Shimizu Y, Kato M, Sakamoto N. Delayed bleeding and hemorrhage of mucosal defects after gastric endoscopic submucosal dissection on second-look endoscopy. Gastric Cancer. 2016 Apr;19(2):561-567. doi: 10.1007/s10120-015-0507-y. Epub 2015 Jun 19.

    PubMed 26089283

  • Kim SB, Lee SH, Kim KO, Jang BI, Kim TN, Jeon SW, Kwon JG, Kim EY, Jung JT, Park KS, Cho KB, Kim ES, Kim HJ, Park CK, Park JB, Yang CH. Risk Factors Associated with Rebleeding in Patients with High Risk Peptic Ulcer Bleeding: Focusing on the Role of Second Look Endoscopy. Dig Dis Sci. 2016 Feb;61(2):517-22. doi: 10.1007/s10620-015-3846-y. Epub 2015 Aug 22.

    PubMed 26297133

  • Bustamante-Balen M, Plume G. Role of hemostatic powders in the endoscopic management of gastrointestinal bleeding. World J Gastrointest Pathophysiol. 2014 Aug 15;5(3):284-92. doi: 10.4291/wjgp.v5.i3.284.

    PubMed 25133029

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Endo-Clot(TM) in people with Bleeding at Gastric Cancer, run by Yonsei University 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 5 inclusion and 18 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 8 Apr 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jun Chul Park, MD (+ 82-2-2228-2272, JUNCHUL75@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rebleeding rate (time frame: within 30 days). 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 NCT02732483, which also lists 16 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 8 Apr 2016.

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