Endoscopic Band Ligation Vs APC in Management of GAVE

Assiut University

Status: Not yet enrolling

Conditions: GAVE - Gastric Antral Vascular Ectasia

Treatments: Procedure: endoscopic band ligation; Procedure: argon plasma coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05258604

endoscopic management of GAVE

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

argon plasma coagulation (APC).

Experimental group

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.

Treatment:

Procedure: argon plasma coagulation

endoscopic band ligation.

Experimental group

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.

Treatment:

Procedure: endoscopic band ligation