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In this randomized trial involving patients with cirrhosis and acute variceal bleeding who were at high risk for treatment failure, control of bleeding was more common and mortality was lower among patients assigned to early treatment with a transjugular intrahepatic portosystemic shunt (TIPS) than among those assigned to standard treatment with rescue TIPS, if needed. In patients with cirrhosis and acute variceal bleeding who were at high risk for treatment failure, control of bleeding was more common and mortality was lower among patients assigned to early treatment with a transjugular intrahepatic portosystemic shunt (TIPS) than among those assigned to standard treatment. Variceal bleeding is a severe complication of portal hypertension and a major cause of death in patients with cirrhosis. Advanced liver failure, failure to control variceal bleeding, early rebleeding, and marked elevations in portal pressure are associated with increased mortality. 1 – 3 Combined treatment with vasoactive drugs, prophylactic antibiotics, and endoscopic techniques is the recommended standard of care for patients with acute variceal bleeding. 4 , 5 However, treatment failure occurs in about 10 to 15% of patients, 6 , 7 who require repeat endoscopic treatments and multiple transfusions. 8 – 10 Treatment with a transjugular intrahepatic portosystemic shunt (TIPS) is highly effective in the control of . . .

ObjectiveThis randomised trial aimed to address whether endoscopic variceal ligation (EVL) or propranolol (PPL) is more effective at preventing initial oesophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma (HCC).DesignPatients with HCC and medium-to-large oesophageal varices (EVs) but without previous EVB were randomised to receive EVL (every 3–4 weeks until variceal eradication) or PPL (up to 320 mg daily) at a 1:1 ratio. Long-term follow-up data on EVB, other upper gastrointestinal bleeding (UGIB), non-bleeding liver decompensation, overall survival (OS) and adverse events (AEs) were analysed using competing risk regression.ResultsBetween June 2011 and April 2021, 144 patients were randomised to receive EVL (n=72) or PPL (n=72). In the EVL group, 7 patients experienced EVB, and 30 died; in the PPL group, 19 patients had EVB, and 40 died. The EVL group had a lower cumulative incidence of EVB (Gray’s test, p=0.009) than its counterpart, with no mortality difference (Gray’s test, p=0.085). For patients with Barcelona Clinic Liver Cancer (BCLC) stage A/B, EVL was better than PPL in reducing EVB (p<0.001) and mortality (p=0.003). For patients beyond BCLC stage B, between-group outcomes were similar. Other UGIB, non-bleeding liver decompensation and AEs did not differ between groups. A competing risk regression model confirmed the prognostic value of EVL.ConclusionEVL is superior to PPL in preventing initial EVB in patients with HCC. The benefits of EVL on EVB and OS may be limited to patients with BCLC stage A/B and not to those with BCLC stage C/D.Trial registration number NCT01970748.

INTRODUCTION:Endoscopic variceal ligation (EVL) plus nonselective β-blockers (NSBB) is the standard of care for secondary prophylaxis of esophageal variceal bleeding (EVB). This trial aimed to compare the rebleeding rates between EVL plus NSBB till eradication of esophageal varices (EEV) and EVL plus long-term NSBB.METHODS:After control of acute EVB, patients with cirrhosis were randomized into 2 groups, with group A patients receiving EVL plus propranolol till EEV, while group B patients received standard of care with continuation of propranolol. Recurrent varices were ligated at follow-up endoscopy in both groups.RESULTS:The median follow-up period was 23.0 months in group A (n = 106) and 23.6 months in group B (n = 106). Twelve patients (11.3%) in group A and 11 (10.4%) in group B had recurrent EVB. The difference in rebleeding rates and the 95% confidence interval (CI) was 0.9% (−7.5% to 9.3%). The upper 95% CI bound of the difference was within the margin of 13.2%, and the noninferiority of group A to group B was established. Thirty-eight patients (35.8%) in group A and 40 (37.7%) in group B had further decompensation, with the difference (95% CI) of −1.9% (−14.9% to 11.1%). Twenty-four patients (22.6%) in group A and 26 (24.5%) in group B expired, with the difference (95% CI) in mortality rates of −1.9% (−13.3% to 9.5%).DISCUSSION:EVL plus propranolol till EEV was noninferior to EVL plus continuing propranolol in secondary prophylaxis of EVB, but the impact on further decompensation and transplantation-free survival deserved further investigation.

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).

BackgroundHerein, our group designed a novel technology, termed balloon compression-assisted endoscopic injection sclerotherapy (bc-EIS), which was applied to improve the efficiency of eradicating esophageal varices (EVs). The present study aimed to compare the rate of eradication and efficacy between bc-EIS and endoscopic variceal ligation (EVL) in the management of EVs.MethodsNinety-five patients with esophageal variceal bleeding (EVB) were randomly assigned to receive bc-EIS or ligation alone. Additional treatment sessions were held 1 month later and then at 3-month intervals until eradication of the varices was achieved. Endoscopic follow-up examinations were carried out at 6-month intervals in the absence of recurrence or immediately if there was any recurrent bleeding.ResultsThe mean physical injection points per session were 2.89 ± 0.79, and the mean volume of lauromacrogol used per session was 17.74 ± 7.09 ml in the bc-EIS group. The mean band per session was 6.13 ± 0.86. The rate of eradication after one to three rounds of bc-EIS was obviously higher than that of the EVL group (89.36%, 97.87%, and 100% vs. 37.5%, 43.75%, and 47.92%, respectively). Retrosternal pain or discomfort in the bc-EIS group was slightly lower than that in the EVL group (23.4%, 11/47 vs. 31.25%, 15/48). Two and five patients showed mild abdominal bloating and distension between the bc-EIS and EVL groups, respectively (2/47, 4.26% vs. 5/48, 10.42% P > 0.05). Nausea and vomiting were reported in one patient (1/47, 2.13%) in the bc-EIS group and three patients (3/48, 6.25%) in the EVL group. However, there were no statistically significant differences between the two groups (P > 0.05). No fatal or severe complications, such as esophageal perforation, esophageal stricture or ectopic embolism, were observed.ConclusionThe bc-EIS method was effective in eradicating EVs and was accompanied by fewer complications.

IntroductionLiver cirrhosis and its severe complication, oesophageal variceal bleeding (EVB), pose significant health risks. Standard treatment for EVB combines non-selective beta-blockers (NSBB) with endoscopic variceal ligation (EVL). Carvedilol, an NSBB with additional benefits, is preferred for compensated cirrhosis. However, no randomised controlled trial (RCT) has compared carvedilol with propranolol, a conventional NSBB, in combination with EVL for secondary prophylaxis. This study aims to compare the effectiveness and safety of these treatments in preventing variceal rebleeding or death in patients with cirrhosis and EVB.Methods and analysisThis multicentre, RCT is scheduled to begin in December 2024, with recruitment and follow-up continuing until December 2026. Eligible participants are patients with liver cirrhosis and EVB. Participants are randomly assigned in a 1:1 ratio to receive EVL combined with either carvedilol or propranolol. The primary endpoint is the incidence of variceal rebleeding or all-cause death. Secondary endpoints include all-cause death, liver-related death, each of the complications of portal hypertension (overt ascites, overt hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome, portal vein thrombosis), hepatocellular carcinoma, changes in liver function (assessed by Child-Pugh and Model for End-Stage Liver Disease scores), changes in liver stiffness, changes in spleen stiffness, and adverse events. Subgroup and sensitivity analyses will be conducted to evaluate the consistency and robustness of the treatment effects. A total sample size of 524 patients (262 per group) is required to detect a significant difference between the treatment arms.Ethics and disseminationThe study protocol has been approved by the ethics committee of the First Hospital of China Medical University (No. 2024-656-2). The study will follow the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this trial will be disseminated through peer-reviewed publications, conference presentations and healthcare professionals to guide future clinical practice.Trial registration numberChinese Clinical Trial Registry (Registration number: ChiCTR2400089692).

Background Esophagogastric variceal bleeding is the most common lethal factor for patients with cirrhotic portal hypertension. We firstly developed a laparoscopic splenectomy and azygoportal disconnection (LSD) with intraoperative endoscopic variceal ligation (LSDL) technique. In this study, we aimed to evaluate whether LSDL is feasible and safe and whether LSDL can effectively prevent esophagogastric variceal re-bleeding (EVR), as compared with single LSD. Methods In this randomized controlled single-center study, 88 patients with cirrhosis who had esophagogastric variceal bleeding and hypersplenism were randomly assigned to receive either LSD ( n  = 44) or LSDL ( n  = 44) between January 2020 and December 2021. The primary outcome was EVR. Results No patients withdrew from the study. There were no significant differences in estimated blood loss, incidence of blood transfusion, time to first flatus and off-bed activity, or postoperative hospital stay between the two groups. Compared with that in the LSD group, operation time was significantly longer in the LSDL group (138.5 ± 19.4 min vs. 150.3 ± 19.0 min, P  < 0.05); however, LSDL was associated with a significantly decreased EVR rate at 1-year follow-up (8/44 vs. 1/44, P  < 0.05). Univariate analysis and multivariate logistic regression revealed that LSDL was a significant independent protective factor against EVR in comparison with LSD (relative risk: 0.105, 95% confidence interval 0.012–0.877; P  = 0.037). Conclusions Our newly developed LSDL procedure is not only technically feasible and safe; it also contributed to lowering the EVR risk more so than single LSD. Trial Registration We registered our research at https://www.clinicaltrials.gov/ . The name of research registered is “Laparoscopic Splenectomy and Azygoportal Disconnection with Intraoperative Endoscopic Variceal Ligation.” The trial registration identifier at clinicaltrials.gov is NCT04244487.

Introduction Gastroesophageal varices (GOV) bleeding is a common and serious complication of advanced liver cirrhosis with a median survival of less than 2 years. Multiple guidelines have pointed out that transjugular intrahepatic portosystemic shunt (TIPS) is the rescue treatment of acute variceal hemorrhage (AVB) after failure of standard therapy and an effective second-line treatment for preventing patients with high risks from rebleeding of GOV. The safety and stability of TIPS have been greatly improved due to the improvements of related technologies and the emergence of various novel devices, but the incidence of hepatic encephalopathy (HE) after shunting (10–50%) hindered the widespread use of TIPS. The target portal vein branch might affect the incidence of HE after TIPS. The aim of this study is to compare the rate of HE in patients with hepatitis B virus (HBV) related cirrhosis receiving TIPS either the left or right branch of the portal vein with 8mm Viatorr stent for preventing rebleeding from GOV. Methods and analysis This study is a multicenter randomized controlled trial comparing the influence of shunting left or right portal vein branch on post-TIPS hepatic encephalopathy for preventing rebleeding from GOV in patients with HBV-related cirrhosis. A total of 130 patients will be recruited over a period of 24 months across 5 centers in China. Eligible patients will be stratified 1:1 to constructing either a left or right portal vein shunt with an 8-mm Viatorr stent. The primary objective was to compare the incidence of post-TIPS hepatic encephalopathy between the two groups. The secondary objectives were to compare the grade and duration of hepatic encephalopathy, the rate of shunt dysfunction, the rate of variceal rebleeding, the HE-free survival, the cumulative patency rate of the stent, and the overall survival at 12 months and 24 months between two groups. Ethics and dissemination This study was approved by the ethics committee of Zhongshan Hospital of Fudan University (No. B2018-292R) and was registered at ClinicalTrials.gov (NCT03825848). All participants give written informed consent. Trial registration ClinicalTrials.gov NCT03825848. Registered on January 31, 2019 Trial status The first patient was recruited into our study on June 19, 2019. A total of 55 patients were recruited till May 27, 2021 (27 and 28 patients assigned to shunting the left (L Group) and right (R Group) branches of the portal vein, respectively).

These guidelines on transjugular intrahepatic portosystemic stent-shunt (TIPSS) in the management of portal hypertension have been commissioned by the Clinical Services and Standards Committee (CSSC) of the British Society of Gastroenterology (BSG) under the auspices of the Liver Section of the BSG. The guidelines are new and have been produced in collaboration with the British Society of Interventional Radiology (BSIR) and British Association of the Study of the Liver (BASL). The guidelines development group comprises elected members of the BSG Liver Section, representation from BASL, a nursing representative and two patient representatives. The quality of evidence and grading of recommendations was appraised using the GRADE system. These guidelines are aimed at healthcare professionals considering referring a patient for a TIPSS. They comprise the following subheadings: indications; patient selection; procedural details; complications; and research agenda. They are not designed to address: the management of the underlying liver disease; the role of TIPSS in children; or complex technical and procedural aspects of TIPSS.

IntroductionGastro-oesophageal variceal bleeding is one of the most common and severe complications with high mortality in cirrhotic patients who developed portal hypertension. Hepatic venous pressure gradient (HVPG) is a globally recommended golden standard for the portal pressure assessment and an HVPG ≥16 mm Hg indicates a higher risk of death and rebleeding. This study aims to compare the effectiveness and safety of splenectomy and pericardial devascularisation (laparoscopic therapy) plus propranolol and endoscopic therapy plus propranolol for variceal rebleeding in cirrhotic patients with HVPG between 16 and 20 mm Hg.Methods and analysisThis is a multicenter, randomised, controlled clinical trial. Participants will be 1:1 assigned randomly into either laparoscopic or endoscopic groups. Forty participants whose transjugular HVPG lies between 16 and 20 mm Hg with a history of gastro-oesophageal variceal bleeding will be recruited from three sites in China. Participants will receive either endoscopic therapy plus propranolol or laparoscopic therapy plus propranolol. The primary outcome measure will be the occurrence of gastro-oesophageal variceal rebleeding. Secondary outcome measures will include overall survival, occurrence of hepatocellular carcinoma, the occurrence of venous thrombosis, the occurrence of adverse events, quality of life and tolerability of treatment. Outcome measures will be evaluated at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks and 60 weeks. Multivariate COX regression model will be introduced for analyses of occurrence data and Kaplan-Meier analysis with the log-rank test for intergroup comparison.Ethics and disseminationEthical approval was obtained from all three participating sites. Primary and secondary outcome data will be submitted for publication in peer-reviewed journals and widely disseminated.Trial registration numberNCT03783065; Pre-results.Trial statusRecruitment for this study started in December 2018 while the first participant was randomised in January 2019. Recruitment is estimated to stop in October 2019.