Long-term impact of scheduled regular endoscopic interventions for patients with primary sclerosing cholangitis.

BACKGROUND: Primary sclerosing cholangitis (PSC) is associated with biliary obstructions that can require endoscopic retrograde cholangiopancreatography (ERCP). While the beneficial effects of ERCP are well documented, follow-up interventional strategies are less defined, and their long-term impact is debated. METHODS: We evaluated the outcome of a scheduled program of ERCP-guided interventions that have been developed and implemented at our tertiary liver center for more than 20 years. Within our center, follow-up ERCPs were performed at regular intervals to treat previously detected morphological stenosis independent of clinical symptoms. We calculated the transplant-free survival (TFS) of patients who were enrolled in the scheduled ERCP program and compared it to patients who received follow-up ERCPs only on clinical demand. Moreover, we documented the occurrence of hepatic decompensation, recurrent cholangitis episodes, hepatobiliary malignancies, and endoscopy-related adverse events. RESULTS: In our retrospective study, we included 201 patients with PSC who all received an ERCP. In all, 133 patients received scheduled follow-up ERCPs and 68 received follow-up ERCPs only on demand. The rates of TFS since initial diagnosis (median TFS: 17 vs. 27 y; P = 0.020) and initial presentation (median TFS: 16 vs. 11 y; P = 0.002) were higher in patients receiving scheduled versus on-demand ERCP. Subgroup analysis revealed that progression in cholangiographic findings between the first and second ERCP was associated with a poorer outcome compared to patients without progression (17 y vs. undefined; P = 0.021). CONCLUSION: In conclusion, we report the outcome data of a scheduled follow-up ERCP program for patients with PSC in an experienced high-volume endoscopy center. Our data suggest the initiation of multicenter randomized controlled prospective trials to explore the full potential of regular endoscopic follow-up treatment as a strategy to prevent disease progression in patients with PSC.

Intragastric Single-Port Surgery: An Innovative and Multipurpose Technique for the Therapy of Upper Digestive Tract Lesions.

Background: Endoscopic treatment can represent a technical challenge for several special situations, such as resecting gastric tumors with larger size or in unfavorable sites and performing endoscopic retrograde cholangiopancreatography (ERCP) after Roux-en-Y gastric bypass (RYGB). This study aims to describe an innovative and multipurpose technique, intragastric single-port surgery (IGS), which can be applied for abovementioned special situations and for assessing its safety, feasibility, and efficacy. Methods: IGS technique was performed through a 2-3 cm skin incision, where the stomach wall is exteriorized and fixed to the skin. The single-port device is inserted and intragastric access is gained for laparoscopic or endoscopic instruments. Three purposes of IGS were performed: (1). gastric intraluminal lesions resection; (2). to perform ERCP after RYGB; and (3). revision of pancreaticogastric anastomosis after pylorus-preserving pancreaticoduodenectomy. Results: IGS was performed successfully in 20 patients. Ten patients underwent gastric intraluminal lesion resection, mostly for gastric gastrointestinal stromal tumors (n = 7, 70%); all pathological specimens were with negative margin, mean operation time was 102.3 ± 43.5 minutes, and mean postoperative hospital stay was 4.6 ± 1.5 days. Nine patients underwent ERCP after RYGB, cleaning of the bile duct was successful in all patients (100%), and mean operation time and mean postoperative hospital stay were 140.6 ± 46.3 minutes and 4.4 ± 2.6 days, respectively. One patient underwent pancreaticogastric anastomosis revision. There were no mortalities in our series. Conclusions: IGS is a safe, feasible, and effective technique for gastric intraluminal lesion resection and for performing ERCP after RYGB, while it has the potential for other future applications.

Endoscopic Sleeve Gastroplasty (ESG) for High-Risk Patients, High Body Mass Index (> 50 kg/m2) Patients, and Contraindication to Abdominal Surgery.

BACKGROUND: For high-risk classified patients, patients with superobesity and in cases of contraindication to abdominal surgery, traditional bariatric surgery might lead to potential morbidity and mortality. Endoscopic sleeve gastroplasty (ESG) is a novel and effective bariatric therapy for morbidly obese patients. Our research group initially evaluated the safety, feasibility, and efficacy of ESG for high-risk, high body mass index (BMI) patients, and patients contraindicated to abdominal surgeries. METHODS: Eligible patients characterized as high-risk for bariatric surgery due to high-BMI, severe comorbidities, or impenetrable abdomen were prospectively documented. ESG was performed by using Overstich® (Apollo Endosurgery, Austin, TX, USA). Primary outcomes included technical success, post-procedure adverse events and mortality, and the change of weight and BMI. RESULTS: ESG was successfully performed for all patients (N = 24, mean age was 55.6 (± 9.2) years old, 75% male). Baseline weight and BMI were 157.9 (± 49.1) kg and 49.9 (± 14.4) kg/m2. According to Edmonton Obesity Staging System (EOSS), 8 (33.3%), 14 (58.3%), and 2 (8.3%) patients were respectively classified as EOSS 2, 3, and 4. Mean operation time was 114.7 (± 26.0) min, without intraoperative complication. Weight loss, BMI reduction, %total weight loss (%TWL), and %excess weight loss (%EWL) were 17.5 (± 14.6) kg, 5.6 (± 4.6) kg/m2, 12.2% (± 8.9%), and 29.1% (± 17.9%) at post-ESG 12-month, respectively. One (4.2%) moderate post-procedure adverse event (gastric mucosal bleeding) was observed. CONCLUSIONS: ESG can be used as a safe, feasible, and effective option for the therapy of patients with superobesity, high-risk patients, and patients contraindicated to abdominal surgery. Graphical Abstract.

Ischemic-Type Biliary Lesions After Liver Transplant: Factors Causing Early-Onset Versus Late-Onset Disease.

OBJECTIVES: Biliary complications such as an ischemic-type biliary lesion can increase morbidity and mortality after liver transplant. Former studies have investigated several risk factors, but the underlying pathomechanism remains unclear. The focus of this study was to investigate factors causing early-onset (< 12 mo after liver transplant) versus late-onset ischemic-type biliary lesions (> 12 mo after liver transplant). MATERIALS AND METHODS: This retrospective study included 641 patients. Patients were grouped to those who developed ischemic-type biliary lesion and those who did not. Patients developing ischemic-type biliary lesions were further subgrouped into those diagnosed early (< 12 mo) and late (> 12 mo) after liver transplant. We analyzed demographic data, characteristics, and comorbidities of the recipients and donors, operative variables, and postoperative course, as well as laboratory values. RESULTS: The incidence of ischemic-type biliary lesions was 4.9%. Retransplant was performed more frequently in patients developing ischemic-type biliary lesions. The number of transfusions of blood products was higher in ischemic-type biliary lesion patients, especially in the early-onset ischemic-type biliary lesion group. Bilirubin levels were higher in patients with ischemic-type biliary lesions starting from day 7 after the operation, particularly in the early-onset group. Survival tended to be best in the late-onset ischemic-type biliary lesion group; however, this difference was not significant. CONCLUSIONS: This study serves as a supplement to current data and the understanding of ischemic-type biliary lesions with emphasis on the relevance of disease onset and causes. We could in fact determine transfusion of blood products as a determinant of an early onset of ischemic-type biliary lesion. Bilirubin could be a surrogate marker for ischemic-type biliary lesions, especially in its early-onset form.

Erratum to "Expression Analysis of Fibronectin Type III Domain-Containing (FNDC) Genes in Inflammatory Bowel Disease and Colorectal Cancer".

[This corrects the article DOI: 10.1155/2019/3784172.].

Expression Analysis of Fibronectin Type III Domain-Containing (FNDC) Genes in Inflammatory Bowel Disease and Colorectal Cancer.

BACKGROUND: Fibronectin type III domain-containing (FNDC) proteins fulfill manifold functions in tissue development and regulation of cellular metabolism. FNDC4 was described as anti-inflammatory factor, upregulated in inflammatory bowel disease (IBD). FNDC signaling includes direct cell-cell interaction as well as release of bioactive peptides, like shown for FNDC4 or FNDC5. The G-protein-coupled receptor 116 (GPR116) was found as a putative FNDC4 receptor. We here aim to comprehensively analyze the mRNA expression of FNDC1, FNDC3A, FNDC3B, FNDC4, FNDC5, and GPR116 in nonaffected and affected mucosal samples of patients with IBD or colorectal cancer (CRC). METHODS: Mucosa samples were obtained from 30 patients undergoing diagnostic colonoscopy or from surgical resection of IBD or CRC. Gene expression was determined by quantitative real-time PCR. In addition, FNDC expression data from publicly available Gene Expression Omnibus (GEO) data sets (GDS4296, GDS4515, and GDS5232) were analyzed. RESULTS: Basal mucosal expression revealed higher expression of FNDC3A and FNDC5 in the ileum compared to colonic segments. FNDC1 and FNDC4 were significantly upregulated in IBD. None of the investigated FNDCs was differentially expressed in CRC, just FNDC3A trended to be upregulated. The GEO data set analysis revealed significantly downregulated FNDC4 and upregulated GPR116 in microsatellite unstable (MSI) CRCs. The expression of FNDCs and GPR116 was independent of age and sex. CONCLUSIONS: FNDC1 and FNDC4 may play a relevant role in the pathobiology of IBD, but none of the investigated FNDCs is regulated in CRC. GPR116 may be upregulated in advanced or MSI CRC. Further studies should validate the altered FNDC expression results on protein levels and examine the corresponding functional consequences.

Diagnostic and therapeutic single-operator cholangiopancreatoscopy with SpyGlassDS™: results of a multicenter retrospective cohort study.

BACKGROUND AND AIMS: The aim of the study was to evaluate the usefulness and diagnostic and therapeutic outcome of the single-operator cholangiopancreatoscopy (SOC) with SpyGlassDS™. METHODS: In a retrospective multicenter study between November 2015 and January 2017, SpyGlassDS™ procedures were analyzed in participating centers. Indications, accuracy of SOC-guided biopsies, management of large bile duct stones, and complications were analyzed. Follow-up was 4 months. RESULTS: Two hundred and six patients out of 250 examinations were evaluated. Indications were biliary stones (n = 132), bile duct stenosis (n = 93), stones and stenosis combined (n = 24), and bile duct leakage (n = 1). Of the 117 cases which were suspicious of malignancy, in 99 cases the lesion could be stratified into benign (n = 55) or malignant (n = 44) indicating a sensitivity of 95.5% and a specificity of 94.5% for the indication tumor. SOC-guided biopsies revealed a sensitivity of 57.7% with a specificity of 100%. In 107 examinations, biliary stones were visualized and could be completely removed in 91.1% with a need of three procedures (range 1-6) to achieve final stone clearance. In 75 cases, lithotripsy was performed and was successful in 71 cases (95%). Four out of 45 patients (8.9%) underwent cholecystectomy with surgical bile duct revision as a final therapy. Adverse Event (AE) occurred in 33/250 patients (13.2%) and Serious Adverse Event (SAE) occurred in 1/250 patients (0.4%). Cholangitis was 1% (n = 102) after peri-interventional administration of antibiotics and 12.8% (n = 148) without antibiotic prophylaxis (p < 0.001). CONCLUSIONS: SOC with SpyGlassDS™ became a new standard for the diagnosis of indefinite biliary lesions and therapy of large bile duct stones. The diagnostic yield of SOC-guided biopsies facilitated a definite diagnosis in most cases and should be improved by standardized biopsy protocols. SOC-guided interventions allowed removal of large biliary stones by SOC-guided lithotripsy. The complication rate of 13.2% can be considerably reduced by use of a single-shot antibiotic treatment.

Secondary Sclerosing Cholangitis in Critically Ill Patients: Clinical Presentation, Cholangiographic Features, Natural History, and Outcome: A Series of 16 Cases.

Secondary sclerosing cholangitis in critically ill patients (SSC-CIP) is an important differential diagnosis in patients presenting with cholestasis and PSC-like cholangiographic changes in endoscopic retrograde cholangiography (ERC). As a relatively newly described entity, SSC-CIP is still underdiagnosed, and the diagnosis is often delayed. The present study aims to improve the early detection of SSC-CIP and the identification of its complications.A total of 2633 records of patients who underwent or were listed for orthotopic liver transplantation at the University Hospital Charité, Berlin, were analyzed retrospectively. The clinical presentation and outcome (mean follow-up 62.7 months) of the 16 identified SSC-CIP cases were reviewed.Cholestasis was the first sign of SSC-CIP. GGT was the predominant enzyme of cholestasis. Hypercholesterolemia occurred in at least 75% of the patients. SSC-CIP provoked a profound weight loss (mean 18 kg) in 94% of our patients. SSC-CIP was diagnosed by ERC in all patients. The 3 different cholangiographic features detected correspond roughly to the following stages: (I) evidence of biliary casts, (II) progressive destruction of intrahepatic bile ducts, and (III) picture of pruned tree. Biliary cast formation is a hallmark of SSC-CIP and was seen in 87% of our cases. In 75% of the patients, the clinical course was complicated by cholangiosepsis, cholangitic liver abscesses, acalculous cholecystitis, or gallbladder perforation. SSC-CIP was associated with worse prognosis; transplant-free survival was ∼40 months (mean).Because of its high rate of serious complications and unfavorable prognosis, it is imperative to diagnose SSC-CIP early and to differentiate SSC-CIP from other types of sclerosing cholangitis. Specific characteristics enable identification of SSC-CIP. Early cooperation with a transplant center and special attention to biliary complications are required after diagnosis of SSC-CIP.

Trigger mechanisms of secondary sclerosing cholangitis in critically ill patients.

INTRODUCTION: In recent years the development of secondary sclerosing cholangitis in critically ill patients (SSC-CIP) has increasingly been perceived as a separate disease entity. About possible trigger mechanisms of SSC-CIP has been speculated, systematic investigations on this issue are still lacking. The purpose of this study was to evaluate the prevalence and influence of promoting factors. METHODS: Temporality, consistency and biological plausibility are essential prerequisites for causality. In this study, we investigated the temporality and consistency of possible triggers of SSC-CIP in a large case series. Biological plausibility of the individual triggers is discussed in a scientific context. SSC-CIP cases were recruited retrospectively from 2633 patients who underwent or were scheduled for liver transplantation at the University Hospital Charité, Berlin. All patients who developed secondary sclerosing cholangitis in association with intensive care treatment were included. Possible trigger factors during the course of the initial intensive care treatment were recorded. RESULTS: Sixteen patients (68% males, mean age 45.87 ± 14.64 years) with a confirmed diagnosis of SSC-CIP were identified. Of the 19 risk factors investigated, particularly severe hypotension with a prolonged decrease in mean arterial blood pressure (MAP) to <65 mmHg and systemic inflammatory response syndrome (SIRS) were established as possible triggers of SSC-CIP. The occurrence of severe hypotension appears to be the first and most significant step in the pathogenesis. It seems that severe hypotension has a critical effect on the blood supply of bile ducts when it occurs together with additional microcirculatory disturbances. CONCLUSIONS: In critically ill patients with newly acquired cholestasis the differential diagnosis of SSC-CIP should be considered when they have had an episode of haemodynamic instability with a prolonged decrease in MAP, initial need for large amounts of blood transfusions or colloids, and early development of a SIRS.

An outbreak of carbapenem-resistant OXA-48 - producing Klebsiella pneumonia associated to duodenoscopy.

BACKGROUND: Carbapenemase-producing Enterobacteriaceae (CPE) have become a major problem for healthcare systems worldwide. While the first reports from European hospitals described the introduction of CPE from endemic countries, there is now a growing number of reports describing outbreaks of CPE in European hospitals. Here we report an outbreak of Carbapenem-resistant K. pneumoniae in a German University hospital which was in part associated to duodenoscopy. FINDINGS: Between December 6, 2012 and January 10, 2013, carbapenem-resistant K. pneumoniae (CRKP) was cultured from 12 patients staying on 4 different wards. The amplification of carbapenemase genes by multiplex PCR showed presence of the bla OXA-48 gene. Molecular typing confirmed the identity of all 12 isolates. Reviewing the medical records of CRKP cases revealed that there was a spatial relationship between 6 of the cases which were located on the same wards. The remaining 6 cases were all related to endoscopic retrograde cholangiopancreatography (ERCP) which was performed with the same duodenoscope. The outbreak ended after the endoscope was sent to the manufacturer for maintenance. CONCLUSIONS: Though the outbreak strain was also disseminated to patients who did not undergo ERCP and environmental sources or medical personnel also contributed to the outbreak, the gut of colonized patients is the main source for CPE. Therefore, accurate and stringent reprocessing of endoscopic instruments is extremely important, which is especially true for more complex instruments like the duodenoscope (TJF Q180V series) involved in the outbreak described here.

Increased T-helper 2 cytokines in bile from patients with IgG4-related cholangitis disrupt the tight junction-associated biliary epithelial cell barrier.

BACKGROUND & AIMS: IgG4-related cholangitis is a chronic inflammatory biliary disease that involves different parts of the pancreatobiliary system, but little is known about its mechanisms of pathogenesis. A T-helper (Th) 2 cell cytokine profile predominates in liver tissues from these patients. We investigated whether Th2 cytokines disrupt the barrier function of biliary epithelial cells (BECs) in patients with IgG4-related cholangitis. METHODS: We assessed the Th2 cytokine profile in bile samples and brush cytology samples from 16 patients with IgG4-related cholangitis and respective controls, and evaluated transcription of tight junction (TJ)-associated proteins in primary BECs from these patients. The effect of Th2 cytokines on TJ-mediated BEC barrier function and wound closure was examined by immunoblot, transepithelial resistance, charge-selective Na(+)/Cl(-) permeability, and 4-kDa dextran flux analyses. RESULTS: Bile samples from patients with IgG4-related cholangitis had significant increases in levels of Th2 cytokines, interleukin (IL)-4, and IL-5. IL-13 was not detected in bile samples, but polymerase chain reaction analysis of whole-brush cytology samples from patients with IgG4-related cholangitis revealed increased levels of IL-13 mRNA, compared with controls. BECs isolated from the brush cytology samples revealed decreased levels of claudin-1 and increased levels of claudin-2 mRNAs. In vitro, IL-4 and IL-13 significantly reduced TJ-associated BEC barrier function by activating claudin-2-mediated paracellular pore pathways. Th2 cytokines also impaired wound closure in BEC monolayers. CONCLUSIONS: Th2 cytokines predominate in bile samples from patients with IgG4-related cholangitis and disrupt the TJ-mediated BEC barrier in vitro. Subsequent increases in biliary leaks might contribute to the pathogenesis of chronic biliary inflammation in these patients.

Oncological superiority of hilar en bloc resection for the treatment of hilar cholangiocarcinoma.

PURPOSE: Long-term results after liver resection for hilar cholangiocarcinoma are still not satisfactory. Previously, we described a survival advantage of patients who undergo combined right trisectionectomy and portal vein resection, a procedure termed "hilar en bloc resection." The present study was conducted to analyze its oncological effectiveness compared to conventional hepatectomy. PATIENTS: During hilar en bloc resection, the extrahepatic bile ducts were resected en bloc with the portal vein bifurcation, the right hepatic artery, and liver segments 1 and 4 to 8. With this "no-touch" technique, preparation of the hilar vessels in the vicinity of the tumor was avoided. The long-term outcome of 50 consecutive patients who underwent curative (R0) hilar en bloc resection between 1990 and 2004 was compared to that of 50 consecutive patients who received curative conventional major hepatectomy for hilar cholangiocarcinoma (perioperative deaths excluded). RESULTS: The 1-, 3-, and 5-year survival rates after hilar en bloc resection were 87%, 70%, and 58%, respectively, which was significantly higher than after conventional major hepatectomy. In the latter group, 1-, 3-, and 5-year survival rates were 79%, 40%, and 29%, respectively (P = 0.021). Tumor characteristics were comparable in both groups. A high number of pT3 and pT4 tumors and patients with positive regional lymph nodes were present in both groups. Multivariate analysis identified hilar en bloc resection as an independent prognostic factor for long-term survival (P = 0.036). CONCLUSIONS: In patients with central bile duct carcinomas, hilar en bloc resection is oncologically superior to conventional major hepatectomy, providing a chance of long-term survival even in advanced tumors.

New endoscopy devices to improve population adherence to colorectal cancer prevention programs.

Despite recent advances in medicine, colorectal cancer (CRC) remains one of the greatest hazards for public health worldwide and especially the industrialized world. It has been well documented with concrete data that regular screening colonoscopy aimed at early detection of precancerous polyps can help decrease the incidence of CRC. However, the adherence of the general population to such screening programs has been shown to be lower than that expected, thus allowing CRC to remain a major threat for public health. Various reasons have been suggested to explain the disappointing compliance of the population to CRC screening programs, some of them associated with colonoscopy per se, which is viewed by many people as an unpleasant examination. Governments, medical societies, individual gastroenterologists, as well as the medical industry are working in order to improve endoscopic devices and/or to improve standard colonoscopy. The aim is to improve the acceptance of the population for this method of CRC screening, by providing a painless and reliable examination of the colon. This review focuses on some of the latest improvements in this field.

ERCP in the sitting position--an alternative technique with potential benefits (with video).

The authors describe a new technique of performing endoscopic retrograde cholangiopancreatography in the sitting position with special emphasis on methods of stabilization of the duodenoscope during the procedure. The article is accompanied by an instructional video. The benefits of this comfortable alternative to the standard standing position and its potential limitations are discussed.

Management of esophageal perforations.

BACKGROUND: Esophageal perforations remain a life-threatening event requiring rapid diagnosis and treatment. Surgical repair and interventional endoscopic or conservative treatment are the common treatment methods. METHODS: From 1998 to 2006, the authors retrospectively analyzed 62 patients treated for esophageal perforation. Data were evaluated for cause of perforation, symptoms, therapeutic regimen, complications, and mortality. RESULTS: The causes of perforation were iatrogenic or suicidal (n = 33) or spontaneous (n = 29). In the first group, the causes were dilation of stenosis (n = 16), endoscopy (n = 7), transesophageal echography (n = 4), ingestion of acid or leach (n = 2), intubation (n = 2), ingestion of a foreign body (n = 1), and migration of a screw after osteosynthesis (n = 1). The spontaneous perforations were caused by tumors (n = 19), Boerhaave syndrome (n = 6), unknown origin (n = 3), and Barrett's ulcer (n = 1). The most frequent symptoms were dysphagia (n = 50), pain (n = 35), fever (n = 24), and vomiting (n = 18). At the time of perforation, 28 patients presented with cancer. Of these 28 patients, 18 had esophageal cancer. The treatment included surgery (n = 32), which consisted of double-layer suture (n = 26) or esophageal resection (n = 6). A total of 30 patients were treated interventionally with a stent (n = 21), clips (n = 1), or without further measures (n = 8). The patients in the surgery group presented with severe primary and postoperative general conditions including renal failure (25%), respiratory insufficiency (65.5%), and need for catecholamines (62.5%). This multiorgan involvement was found only occasionally in the conservative group. The overall hospital mortality rate was 14.5%, involving 9 patients (5 in the surgery group and 4 in the conservative group). Early treatment led to better survival than late treatment with a delay exceeding 24 h. CONCLUSION: The treatment method still must be chosen on an individual basis. It appears that surgical treatment is necessary in cases of severe general conditions. The data from this study show that surgical repair and conservative treatment may be used successfully. The best outcome was obtained after immediate treatment.

Prospective pilot evaluation of a new needle prototype for endoscopic ultrasonography-guided fine-needle aspiration: comparison of cytology and histology yield.

OBJECTIVES: Endoscopic ultrasonography (EUS) with the adjunct of EUS-guided fine needle aspiration has become an important diagnostic modality in gastroenterologic oncology. EUS-guided fine needle aspiration mainly relies on cytology; data are scarce that compare cytology and histology. While testing a 22-gauge prototype needle, we prospectively compared the yield for both. METHODS: Forty-two consecutive patients (27 male, 15 female; mean age 59.2 years, range: 17-90 years) were included. In each patient we aimed to make two needle passes, and if the material acquired appeared insufficient macroscopically (no in-room cytopathology was available), further passes were done. The material was sent for cytological and histological assessment. RESULTS: A median number of two passes (range: 2-3) were uneventfully performed for pancreatic lesions (n=30), mediastinal and other lymph nodes/masses (n=8) and various other lesions (n=4) and yielded adequate material for cytology, histology or at least one of the two investigations in 62, 67 and 74% of patients, respectively. No false positive results were found (specificity 100%). Sensitivities were 58.6 and 65.5%, respectively, for cytology and histology alone; combined assessment increased sensitivity to 79.3%. When adjusted values were calculated, based only on those cases with adequate material, sensitivity was 89.5% for cytology and 85.7% for histology, and increased to 100% with combined assessment. CONCLUSION: The new needle achieves sensitivities similar to those previously reported with no significant differences in sensitivity between cytology and histology. More effective tissue acquisition methods must be sought to improve overall results.

Ligation versus propranolol for the primary prophylaxis of variceal bleeding in cirrhosis.

In this randomized controlled multicenter trial, we compared endoscopic variceal banding ligation (VBL) with propranolol (PPL) for primary prophylaxis of variceal bleeding. One hundred fifty-two cirrhotic patients with 2 or more esophageal varices (diameter >5 mm) without prior bleeding were randomized to VBL (n = 75) or PPL (n = 77). The groups were well matched with respect to baseline characteristics (age 56 +/- 10 years, alcoholic etiology 51%, Child-Pugh score 7.2 +/- 1.8). The mean follow-up was 34 +/- 19 months. Data were analyzed on an intention-to-treat basis. Neither bleeding incidence nor mortality differed significantly between the 2 groups. Variceal bleeding occurred in 25% of the VBL group and in 29% of the PPL group. The actuarial risks of bleeding after 2 years were 20% (VBL) and 18% (PPL). Fatal bleeding was observed in 12% (VBL) and 10% (PPL). It was associated with the ligation procedure in 2 patients (2.6%). Overall mortality was 45% (VBL) and 43% (PPL) with the 2-year actuarial risks being 28% (VBL) and 22% (PPL). 25% of patients withdrew from PPL treatment, 16% due to side effects. In conclusion, VBL and PPL were similarly effective for primary prophylaxis of variceal bleeding. VBL should be offered to patients who are not candidates for long-term PPL treatment.