Endoscopic Band Ligation Vs APC in Management of GAVE

Not Applicable

• Conditions: GAVE - Gastric Antral Vascular Ectasia
• Interventions: Procedure: endoscopic band ligation; Procedure: argon plasma coagulation

• Registration Number: NCT05258604
• Lead Sponsor: Assiut University

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:

1. Study risk factors of GAVE.

2. 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.

Study Timeline

• Study First Submitted: 2022-01-21
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28
• Study Start: 2022-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic band ligation.	endoscopic band ligation	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.
argon plasma coagulation (APC).	argon plasma coagulation	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.

Primary Outcome Measures

Name	Time	Method
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	two years	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.