A randomized controlled trial comparing large-volume band ligator and cyanoacrylate injection in the endoscopic management of actively bleeding gastric varices

Abstract

Managing actively bleeding gastric varices (GV) is clinically challenging. This study assessed the safety and efficacy of endoscopic band ligation (EBL) using large-volume ligators compared with endoscopic variceal obturation (EVO) in managing actively bleeding GV. Patients who were diagnosed with active GV bleeding via endoscopy and underwent EBL with large-volume band ligators or EVO were enrolled. Follow-up endoscopy was performed at 1, 3, and 6 months after endoscopic treatment. Primary outcomes were the initial haemostasis success rate, GV eradication rate within 3 months, 1-week rebleeding rate, 6-month cumulative rebleeding rate, and recurrence rate within 6 months. Secondary outcomes were the rate and average volume of blood transfusions in patients with rebleeding and adverse events related to endoscopic treatment. Overall, 154 patients were included (EBL group: n = 77; EVO group: n = 77). There were no statistically significant differences between the two groups regarding the initial haemostasis success rate, 1-week rebleeding rate, 3-month GV eradication rate and average number of sessions to GV eradication, cumulative rebleeding rate, and recurrence rate within 6 months. Three of the nine patients with rebleeding in the EVO group required blood transfusion with an average blood transfusion volume that was significantly lower than that required by the five patients with rebleeding in the EBL group (P = 0.024). The fever rate was lower in the EBL group than in the EVO group (P = 0.011). In the EVO group, one patient developed a pulmonary embolism and died during treatment, and three patients developed postoperative sepsis. The short-term efficacy of EBL with large-volume ligators in the treatment of actively bleeding GV is similar to that of EVO; however, postoperative rebleeding is often more dangerous in EBL than in EVO. Therefore, EBL represents a viable alternative in emergency endoscopic control of GV bleeding, provided that a contingency plan for early band slippage-related rebleeding is implemented.Trial registration: Chinese Clinical Trial Registry (No. ChiCTR1900027588, 19/11/2019).

Keywords: Endoscopic band ligation; Endoscopic injection; Gastric varices; Haemostasis.

Fig. 1

Ligation of GOV1 variceal bleeding. (A) Jet bleeding of GOV1 varices is identified using an inverted gastrointestinal endoscope. (B) Endoscopic view of the GV within the ligator cap. (C) After EBL, endoscopic examination shows successful haemostasis. (D) One month after EBL, an inverted endoscopy reveals a post-ligation ulcer. GOV1, Gastroesophageal varices type 1; GV, Gastric varices; EBL, Endoscopic band ligation.

Fig. 2

Ligation of GOV2 variceal bleeding. (A) GOV2 varices and blood accumulation in the gastric cavity are identified using an inverted gastrointestinal endoscope. (B) Endoscopic view of the GV within the ligator cap. (C) After EBL, endoscopic examination shows successful haemostasis. (D) Six months after EBL, an inverted endoscopy examination reveals white scars at the site of EBL. GOV2, Gastroesophageal varices type 2; GV, Gastric varices; EBL, Endoscopic band ligation.

Fig. 3

Ligation of IGV1 variceal bleeding. (A) Jet bleeding in IGV1 varices and blood accumulation in the gastric cavity are observed using an inverted gastrointestinal endoscope. (B) Endoscopic view of GV within the ligator cap. (C) After EBL, endoscopic examination shows successful haemostasis. (D) Three months after EBL, an inverted endoscopy examination reveals scars at the site of EBL. IGV1, Isolated gastric varices type 1; GV, Gastric varices; EBL, Endoscopic band ligation.

Fig. 4

EVO of GOV variceal bleeding. (A) Jet bleeding of GOV1 varices is identified using an inverted gastrointestinal endoscope. (B) Cyanoacrylate is injected into the bleeding site. (C) After EVO, endoscopic examination shows successful haemostasis. (D) Jet bleeding of GOV2 varices is identified using an inverted gastrointestinal endoscope. (E) The injection needle is close to the bleeding site of GV. (F) After EVO, endoscopic examination shows successful haemostasis. EVO, Endoscopic variceal obturation; GOV, Gastroesophageal varices; GOV1, Gastroesophageal varices type 1; GOV2, Gastroesophageal varices type 2; GV, Gastric varices.

Fig. 5

EVO of tortuous GV bleeding with a gastrorenal shunt. (A) Tortuous variceal bleeding is identified using an inverted gastrointestinal endoscope. (B) CTA image of combined gastrorenal shunt. (C) A haemostatic clip is clamped at one end of the GV. (D) On the basis of (C), another haemostatic clip is clamped at the middle stenosis of the GV. (E) Cyanoacrylate is injected into the GV between the two clips. (F) Three months after EVO, inverted endoscopy examination reveals GV occlusion and one haemostatic clip remained. EVO, Endoscopic variceal obturation; GV, Gastric varices; CTA, Computed tomography three-dimensional angiography.