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Endoscopic Band Ligation Vs APC in Management of GAVE

Primary Purpose

GAVE - Gastric Antral Vascular Ectasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
argon plasma coagulation
endoscopic band ligation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GAVE - Gastric Antral Vascular Ectasia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • All causes of emergence upper GIT bleeding other than GAVE.

    • Patient with contraindication to general anesthesia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    argon plasma coagulation (APC).

    endoscopic band ligation.

    Arm Description

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 21, 2022
    Last Updated
    February 17, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05258604
    Brief Title
    Endoscopic Band Ligation Vs APC in Management of GAVE
    Official Title
    Endoscopic Band Ligation Versus Argon Plasma Coagulation in Management of Gastric Antral Vascular Ectasia; Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    May 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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: Study risk factors of GAVE. Prevalence of GAVE among causes of non-variceal gastrointestinal bleeding.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    GAVE - Gastric Antral Vascular Ectasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    argon plasma coagulation (APC).
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    endoscopic band ligation.
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    argon plasma coagulation
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    endoscopic band ligation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Description
    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 incidence of re-bleeding Need for blood transfusion according to numbers of packed red blood cells units. Hospital stay and total cost. post procedure gastric ulceration detected by upper endoscopy.
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • 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. Exclusion Criteria: • All causes of emergence upper GIT bleeding other than GAVE. Patient with contraindication to general anesthesia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Esraa swifee, assistant lecturer
    Phone
    00201000700150
    Email
    esraayousef27@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    osman abdelhameed, professor
    Phone
    00201222302355

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29255747
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23330048
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23418384
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29399041
    Citation
    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). Therap Adv Gastroenterol. 2018 Jan 14;11:1756283X17747471. doi: 10.1177/1756283X17747471. eCollection 2018.
    Results Reference
    background
    PubMed Identifier
    12612530
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19028211
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17140926
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23808945
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22725108
    Citation
    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.
    Results Reference
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