Introduction: Interventional therapy is an emerging clinical discipline and a key component of minimally invasive medicine. It stands as an independent field alongside traditional internal medicine and surgery, forming the third major clinical discipline. This approach utilizes advanced imaging techniques—such as digital subtraction angiography (DSA), ultrasound, and CT—to guide the insertion of specialized needles, catheters, and stents through millimeter-sized incisions in the skin. These tools allow physicians to deliver medications, embolic agents, or implants directly into diseased organs and tissues without the need for open surgery.To keep medical professionals updated on the latest advancements in interventional therapy for liver diseases, Hepatology Digesthas launched the Interventional Therapy for Liver and Gallbladder Diseases column in collaboration with Dr. Xuefeng Luo from West China Hospital of Sichuan University. This monthly feature shares cutting-edge research, promotes standardized treatment practices, and tracks the latest developments in interventional procedures, providing valuable insights for specialists, researchers, and frontline healthcare professionals.
Gastric variceal (GV) bleeding is a severe complication of liver cirrhosis, characterized by a high risk of rebleeding and significant mortality. This issue remains a major challenge in clinical management. In this edition, Dr. Xuefeng Luo discusses a recent randomized controlled trial (RCT) that analyzed treatment outcomes for cirrhotic patients with GV bleeding. The study found that interventional therapy significantly reduced rebleeding rates and bleeding-related mortality compared to endoscopic cyanoacrylate injection. These findings offer a new therapeutic strategy for secondary prevention of GV bleeding and provide clinicians with a broader range of treatment options.
Study Summary
Approximately 20% of patients with liver cirrhosis develop GV (Kaplan DE, et al. Hepatology. 2024; 79(5):1180-211). While gastroesophageal varices type 1 (GOV1) are more common, GV bleeding primarily occurs in patients with gastroesophageal varices type 2 (GOV2) and isolated gastric varices type 1 (IGV1). Endoscopic cyanoacrylate injection is the first-line treatment for acute GV bleeding; however, the rebleeding rate remains high, ranging from 15% to 30% (Rios Castellanos E, et al. Cochrane Database Syst Rev. 2015; 2015:CD010180; Henry Z, et al. Clin Gastroenterol Hepatol. 2021; 19:1098-1107). Secondary prevention strategies for GV bleeding include scheduled endoscopic treatments and interventional procedures such as transjugular intrahepatic portosystemic shunt (TIPS) and balloon-occluded retrograde transvenous obliteration (BRTO).
Previous studies have demonstrated that both BRTO and TIPS are more effective in preventing GV rebleeding than cyanoacrylate injection alone, with lower rebleeding rates (Luo X, et al. Hepatology. 2021; 74:2074-2084; Lo GH, et al. Endoscopy. 2007; 39(8):679-85; JHEP Rep. 2023; 5(6):100717; Paleti S, et al. J Clin Gastroenterol. 2020; 54(7):655-60). However, there is no clear consensus on whether interventional therapy (TIPS or BRTO) should be routinely performed after initial cyanoacrylate injection.
A recent study published in Clinical Gastroenterology and Hepatology (2024) titled Endoscopic Cyanoacrylate Injection Versus Combined Endoscopic and Interventional Therapy for the Prevention of Gastric Variceal Bleeding: A Randomized Controlled Trial explored the safety and efficacy of combining interventional therapy with endoscopic treatment for GV rebleeding prevention.
The study enrolled cirrhotic patients with GV bleeding (GOV2 or IGV1) who achieved hemostasis following endoscopic cyanoacrylate injection. Participants were randomly assigned to two groups (45 patients per group). The Endoscopy-Only Group received scheduled cyanoacrylate injections at 1, 3, 6, and 12 months, while the Intervention Group underwent TIPS or BRTO followed by endoscopic follow-up. The primary endpoint was the GV rebleeding rate, while secondary outcomes included overall mortality, bleeding-related mortality, liver function changes, and procedure-related complications. The results demonstrated that combining endoscopic treatment with interventional therapy (BRTO or TIPS) significantly reduced both GV rebleeding rates and bleeding-related mortality.
Key Findings and Clinical Significance
01. Patient Selection and Study Design
Between February 20, 2021, and July 15, 2022, a total of 176 patients with cirrhosis and gastric variceal (GV) bleeding (GOV2 or IGV-1) were screened, of whom 90 were ultimately enrolled and randomly assigned to treatment groups.
02. Baseline Patient Characteristics
The baseline characteristics of both groups were well-matched (P > 0.05). The average patient age was 45.3 (±12.2) years, with a male predominance (68.9%). The median MELD score was 12.4 (range: 9.9–14.4) in the endoscopic cyanoacrylate injection group and 11.7 (range: 9.4–14.7) in the combined endoscopic and interventional therapy group. All patients achieved hemostasis through cyanoacrylate injection without requiring rescue therapy, and all tolerated beta-blockers well. The median follow-up duration was 17.9 months (range: 6.7–22.9) in the endoscopic group and 16.4 months (range: 12.9–21.8) in the combined therapy group.
03. One-Year Follow-Up Outcomes
After one year of follow-up:
- In the endoscopic injection-only group, 13 patients experienced rebleeding (28.9%; 95% CI: 16.4–44.3), including 11 cases of GV rebleeding (24.4%; 95% CI: 12.9–39.5).
- In the combined endoscopic and interventional therapy group, only 3 patients had rebleeding (6.7%; 95% CI: 1.4–18.3), with just 1 case of GV rebleeding (2.2%; 95% CI: 0.1–11.8) (P = 0.011, P = 0.004).
While overall one-year mortality rates were similar between the two groups (P = 0.302), GV-related mortality was significantly higher in the endoscopic injection-only group compared to the combined therapy group (P = 0.030).
04. Rebleeding-Free Survival and Overall Survival
The probability of remaining rebleeding-free at one year and two years was:
- 93.0% and 93.0% in the combined therapy group
- 70.7% and 52.3% in the endoscopic injection-only group
The risk of rebleeding was significantly lower in the combined therapy group compared to the endoscopic-only group (95% CI: 0.04–0.61; P = 0.008).
05. Complications Associated with Endoscopic and Interventional Therapy
- The incidence of hepatic encephalopathy (HE) was higher in the TIPS group (30%; 95% CI: 11.9–54.3) compared to the endoscopic injection-only group (6.7%; 95% CI: 1.4–18.3) (P = 0.020). However, HE was manageable with medication, and no patients required stent diameter reduction.
- Patients who underwent BRTO experienced a higher rate of new-onset or worsening ascites than those receiving endoscopic therapy alone. However, ascites responded well to diuretics, with only one patient requiring TIPS for refractory ascites.
Conclusion and Future Perspectives
For secondary prevention of GV bleeding in cirrhotic patients, combining endoscopic cyanoacrylate injection with interventional therapy (TIPS or BRTO) significantly reduces rebleeding rates and GV-related mortality compared to endoscopic treatment alone.
