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GAVE - Gastric Antral Vascular EctasiaNCT05258604

Endoscopic Band Ligation Vs APC in Management of GAVE

A study testing argon plasma coagulation and endoscopic band ligation in people with GAVE - Gastric Antral Vascular Ectasia, run by Assiut University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

overall aim: To compare the efficacy and safety of endoscopic band ligation and endoscopic argon plasma coagulation for the management of gastric antral vascular ectasia. Secondary aims: 1. Study risk factors of GAVE. 2. Prevalence of GAVE among causes of non-variceal gastrointestinal bleeding. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
GAVE - Gastric Antral Vascular Ectasia
What is being tested?
argon plasma coagulation and endoscopic band ligation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
1 Mar 2022to 30 May 2024
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Both sexes will be included.
  • Age above 18 years old patients will be included.
  • With overt or occult bleeding from GAVE.
  • Characteristic endoscopic findings of GAVE: GAVE was limited to the antrum and its appearance either watermelon stomach or diffuse pattern.

Who cannot join

  • • All causes of emergence upper GIT bleeding other than GAVE.
  • Patient with contraindication to general anesthesia

Trial locations and contacts

No sites are listed yet.

Esraa swifee, assistant lecturer contact

00201000700150

esraayousef27@yahoo.com

osman abdelhameed, professor contact

00201222302355

About this study

Official title: Endoscopic Band Ligation Versus Argon Plasma Coagulation in Management of Gastric Antral Vascular Ectasia; Randomized Clinical Trial

  • overall aim: To compare the efficacy and safety of endoscopic band ligation and endoscopic argon plasma coagulation for the management of gastric antral vascular ectasia.
  • Secondary aims:
  1. Study risk factors of GAVE.
  2. Prevalence of GAVE among causes of non-variceal gastrointestinal bleeding.
Read the detailed description

Gastric antral vascular ectasia (GAVE) is a capillary-type vascular malformation characterized endoscopically by red, angiomatous lesions originating in the antrum and organized either in stripes or in a diffuse pattern.

GAVE may cause chronic iron-deficiency anemia with or without the presence of overt gastrointestinal bleeding, manifested commonly by melena, may account for about 4% of the causes of non-variceal bleeding.

GAVE can be isolated or associated with systemic conditions, especially in patients with liver cirrhosis, scleroderma, chronic renal failure, and after bone marrow transplantation.

Multiple mechanisms have been proposed as the origin of its development. These have included gastric dysmotility leading to chronic mucosal trauma and subsequent fibromuscular hyperplasia and vascular ectasia or an autoimmune reaction to gastric blood vessels among the main contributing factors.

Management of GAVE-related gastrointestinal bleeding is a clinically challenging issue. In the last two decades, many therapeutic options and modalities have been applied for GAVE including medical, endoscopic, and surgical management.

Endoscopic management including different options such as cryotherapy, argon photo coagulation (APC), Neodymium-yttrium-aluminum garnet laser coagulation, radiofrequency ablation and endoscopic band ligation.

The first case using endoscopic band ligation as salvage treatment for GAVE was reported in 2006. After two sessions of EBL with a Multi-Band Ligature, hemoglobin became stable and serum ferritin normalized in 16 months of follow up.

Some studies show that management of GAVE with endoscopic band ligation superior to APC in bleeding cessation and fewer treatment sessions.

Being tested
argon plasma coagulation, endoscopic band ligation
Medical subject headings
Gastric Antral Vascular Ectasia

What participants receive

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

  • argon plasma coagulationProcedure or surgery

    APC Standard APC equipment will be used, consisting of a high-frequency electrosurgical generator (ICC 350; ERBE, Tübingen, Germany), an argon source which is regulated automatically (APC 300) and APC probe.

  • endoscopic band ligationProcedure or surgery

    endoscopic band ligation will be carried out using a Saeed Multi-Band Ligator (Cook Medical, WinstonSalem, NC), and ligation bands were placed on the GAVE.

Study groups in NCT05258604
Study groupRoleWhat they receive
argon plasma coagulation (APC).ExperimentalAPC Standard APC equipment will be used, consisting of a high-frequency electrosurgical generator (ICC 350; ERBE, Tübingen, Germany), an argon source which is regulated automatically (APC 300) and APC probe.
Receives: Procedure: argon plasma coagulation
endoscopic band ligation.Experimentalendoscopic band ligation will be carried out using a Saeed Multi-Band Ligator (Cook Medical, WinstonSalem, NC), and ligation bands were placed on the GAVE.
Receives: Procedure: endoscopic band ligation

What is being measured

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

  1. prevalence of gastric antral vascular ectasia (GAVE) among other causes of gastrointestinal bleeding and study different endoscopic modalities in GAVE management according to its side effects and capacity in management of GAVE

    prevalence OF GAVE will be assessed according to number of cases presented by gastrointestinal bleeding diagnosed as GAVE by upper endoscopy

    side effects of endoscopic modalities will be assessed according

    1. incidence of re-bleeding
    2. Need for blood transfusion according to numbers of packed red blood cells units.
    3. Hospital stay and total cost.
    4. post procedure gastric ulceration detected by upper endoscopy.

    Measured: two years

Timeline

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

  1. First posted28 Feb 2022
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion30 May 2024 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05258604
Sponsor's protocol ID
endoscopic management of GAVE
Status last verified
Feb 2022
First submitted
21 Jan 2022
Last updated
28 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zepeda-Gomez S. Endoscopic Treatment for Gastric Antral Vascular Ectasia: Current Options. GE Port J Gastroenterol. 2017 Jul;24(4):176-182. doi: 10.1159/000453271. Epub 2016 Dec 21.

    PubMed 29255747

  • Fuccio L, Mussetto A, Laterza L, Eusebi LH, Bazzoli F. Diagnosis and management of gastric antral vascular ectasia. World J Gastrointest Endosc. 2013 Jan 16;5(1):6-13. doi: 10.4253/wjge.v5.i1.6.

    PubMed 23330048

  • Hung EW, Mayes MD, Sharif R, Assassi S, Machicao VI, Hosing C, St Clair EW, Furst DE, Khanna D, Forman S, Mineishi S, Phillips K, Seibold JR, Bredeson C, Csuka ME, Nash RA, Wener MH, Simms R, Ballen K, Leclercq S, Storek J, Goldmuntz E, Welch B, Keyes-Elstein L, Castina S, Crofford LJ, Mcsweeney P, Sullivan KM. Gastric antral vascular ectasia and its clinical correlates in patients with early diffuse systemic sclerosis in the SCOT trial. J Rheumatol. 2013 Apr;40(4):455-60. doi: 10.3899/jrheum.121087. Epub 2013 Feb 15.

    PubMed 23418384

  • Hsu WH, Wang YK, Hsieh MS, Kuo FC, Wu MC, Shih HY, Wu IC, Yu FJ, Hu HM, Su YC, Wu DC. Insights into the management of gastric antral vascular ectasia (watermelon stomach). Ther Adv Gastroenterol. 2018 Jan 14;11:1756283X17747471. doi: 10.1177/1756283X17747471. eCollection 2018.

    PubMed 29399041

  • Kantsevoy SV, Cruz-Correa MR, Vaughn CA, Jagannath SB, Pasricha PJ, Kalloo AN. Endoscopic cryotherapy for the treatment of bleeding mucosal vascular lesions of the GI tract: a pilot study. Gastrointest Endosc. 2003 Mar;57(3):403-6. doi: 10.1067/mge.2003.115.

    PubMed 12612530

  • American Society for Gastrointestinal Endoscopy Technology Committee. Mucosal ablation devices. Gastrointest Endosc. 2008 Dec;68(6):1031-42. doi: 10.1016/j.gie.2008.06.018. No abstract available.

    PubMed 19028211

  • Sinha SK, Udawat HP, Varma S, Lal A, Rana SS, Bhasin DK. Watermelon stomach treated with endoscopic band ligation. Gastrointest Endosc. 2006 Dec;64(6):1028-31. doi: 10.1016/j.gie.2006.05.006. Epub 2006 Aug 22. No abstract available.

    PubMed 17140926

  • Keohane J, Berro W, Harewood GC, Murray FE, Patchett SE. Band ligation of gastric antral vascular ectasia is a safe and effective endoscopic treatment. Dig Endosc. 2013 Jul;25(4):392-6. doi: 10.1111/j.1443-1661.2012.01410.x. Epub 2012 Dec 17.

    PubMed 23808945

  • Sato T, Yamazaki K, Akaike J. Endoscopic band ligation versus argon plasma coagulation for gastric antral vascular ectasia associated with liver diseases. Dig Endosc. 2012 Jul;24(4):237-42. doi: 10.1111/j.1443-1661.2011.01221.x. Epub 2011 Dec 29.

    PubMed 22725108

Questions about this trial

What is this clinical trial studying?

A study testing argon plasma coagulation and endoscopic band ligation in people with GAVE - Gastric Antral Vascular Ectasia, run by Assiut University.

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 4 inclusion and 2 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 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Esraa swifee, assistant lecturer (00201000700150, esraayousef27@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prevalence of gastric antral vascular ectasia (GAVE) among other causes of gastrointestinal bleeding and study different endoscopic modalities in GAVE management according to its side effects and capacity in management of GAVE (time frame: two years). 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 NCT05258604, which also lists 9 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 28 Feb 2022.

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