NCT05258604

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

January 21, 2022

Last Update Submit

February 17, 2022

Conditions

GAVE - Gastric Antral Vascular Ectasia

Outcome Measures

Primary Outcomes (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.

    two years

Study Arms (2)

argon plasma coagulation (APC).

EXPERIMENTAL

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.

Procedure: argon plasma coagulation

endoscopic band ligation.

EXPERIMENTAL

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.

Procedure: endoscopic band ligation

Interventions

argon plasma coagulationPROCEDURE

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.

argon plasma coagulation (APC).
endoscopic band ligationPROCEDURE

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.

endoscopic band ligation.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 29255747BACKGROUND

  • 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.

    PMID: 23330048BACKGROUND

  • 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.

    PMID: 23418384BACKGROUND

  • 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.

    PMID: 29399041BACKGROUND

  • 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.

    PMID: 12612530BACKGROUND

  • 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.

    PMID: 19028211BACKGROUND

  • 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.

    PMID: 17140926BACKGROUND

  • 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.

    PMID: 23808945BACKGROUND

  • 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.

    PMID: 22725108BACKGROUND

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia

Interventions

Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesAngiodysplasiaVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ElectrocoagulationCauteryTherapeuticsHemostatic TechniquesAblation TechniquesSurgical Procedures, OperativeHemostasis, Surgical

Central Study Contacts

Esraa swifee, assistant lecturer

CONTACT

00201000700150esraayousef27@yahoo.com

osman abdelhameed, professor

CONTACT

00201222302355

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 28, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2024

Study Completion

May 30, 2024

Last Updated

February 28, 2022

Record last verified: 2022-02