Randomised phase II trial of photodynamic therapy plus oral fluoropyrimidine, S-1, versus photodynamic therapy alone for unresectable hilar cholangiocarcinoma.

BACKGROUND: Hilar cholangiocarcinoma is an uncommon cancer and its overall incidence is increasing. Photodynamic therapy (PDT) has been proposed as palliative management for unresectable hilar cholangiocarcinoma (UHC). To date, little is known about the role of the addition of systemic chemotherapy to PDT for UHC. We performed a prospective, randomised, phase II trial to compare PDT plus S-1 and PDT alone for UHC. METHODS: Patients with UHC were randomly assigned (in a 1:1 ratio) to PDT plus S-1 or PDT alone. The primary end-point was overall survival. The secondary end-points were progression-free survival, complications, re-intervention rate and quality of life. This trial is registered with clinicalTrials.gov, number NCT00869635. FINDINGS: Between February 2009 and May 2012, we randomly assigned 21 patients to receive PDT plus S-1 and 22 to receive PDT alone. The UHC patients treated with PDT plus S-1 showed higher 1-year survival rate compared with the patients treated with PDT alone (76.2% versus 32%, P=0.003) and prolonged overall survival (median 17 months, 95% confidence interval [CI]: 12.6-21.4, versus 8 months, 95% CI: 6-10, P=0.005, hazard ratio [HR], 0.36; 95% CI: 0.17-0.75). Regarding the secondary end-points, PDT plus S-1 was associated with prolonged progression-free survival compared with PDT alone (median 10 months [95% CI: 4.1-16] versus 2 months [95% CI: 0.4-3.5], P=0.009 (HR for progression 0.39, 95% CI: 0.19-0.83). There were no differences in the number of PDT sessions, the frequency of cholangitis, overall adverse events or the quality of life in either group. INTERPRETATIONS: PDT plus S-1 was well tolerated and was associated with a significant improvement of overall survival and progression-free survival compared with PDT alone in patients with UHC. These findings warrant further clinical investigation of PDT plus S-1 in patients with UHC.

A Comparison of 2 L of Polyethylene Glycol and 45 mL of Sodium Phosphate versus 4 L of Polyethylene Glycol for Bowel Cleansing: A Prospective Randomized Trial.

BACKGROUND/AIMS: Polyethylene glycol (PEG)-based gut lavage solutions are safe and effective, but require the intake of large volumes of fluid. The use of 2 L PEG plus 45 mL sodium phosphate (PEG2 plus NaP) was compared with 4 L PEG (PEG4) for bowel cleansing before colonoscopy. METHODS: Patients were randomized to the PEG2 plus NaP group or PEG4 group between January 1, 2009 and March 31, 2010. One hundred and thirty patients were included in the PEG2 plus NaP group, and 141 patients in the PEG4 group. RESULTS: The qualities of the bowel preparation, based on the Ottawa scale were not significantly different between the groups (4.8±2.25 for the PEG2 plus NaP group vs. 5.11±2.26 for the PEG4). In addition, there were no significant differences in side effects. Laboratory findings after bowel preparation, including electrolyte, phosphorus and creatinine levels, were within the normal ranges in both groups. CONCLUSIONS: PEG2 plus NaP provides good cleansing that is similar to PEG4, but with a lower volume. However, because PEG2 plus NaP can cause serious side effects such as calcium deposition in the kidneys (i.e., nephrocalcinosis), this solution might be considered for the outpatients who cannot tolerate PEG4.

HBV DNA level at 24 weeks is the best predictor of virological response to adefovir add-on therapy in patients with lamivudine resistance.

BACKGROUND: The aim of this study was to investigate the relationship between HBV DNA levels at baseline and on-treatment and the virological response at 96 weeks after adefovir add-on therapy in chronic hepatitis B (CHB) patients with lamivudine resistance. METHODS: Lamivudine and adefovir combination therapy was administered to 122 CHB patients for >24 months. RESULTS: Virological response (HBV DNA negativity) was achieved in 53 (43.3%) and 62 patients (50.8%) at 48 and 96 weeks, respectively. The receiver operating characteristic curve analysis showed that the HBV DNA level at week 24 had a greater power (area under the receiver operating characteristic curve 0.978; 95% CI 0.949, 1.000; P<0.001) to predict the virological response at week 96 of treatment than did the pre-treatment HBV DNA level (area under the receiver operating characteristic curve 0.771; 95% CI 0.640, 0.902; P<0.001). The best cutoff value for the HBV DNA level, at week 24, for the prediction of the virological response at week 96 was 200 IU/ml (3 log(10) copies/ml), with a sensitivity and specificity of 90.3% and 95.0%, respectively. Using this time frame and cutoff value, 56 (90.3%) out of 62 patients that had a virological response at 96 weeks had <200 IU/ml HBV DNA at 24 weeks. CONCLUSIONS: Although the HBV DNA level at baseline is often used to predict the antiviral potency of lamivudine and adefovir combination treatment in CHB patients with lamivudine resistance, the results of this study suggest that the HBV DNA level at 24 weeks is a better marker for the virological response.

The prospective randomized, controlled trial of endoscopic ultrasound-guided fine-needle aspiration using 22G and 19G aspiration needles for solid pancreatic or peripancreatic masses.

OBJECTIVES: A large-caliber needle such as a 19-gauge needle may help overcome the limitations of a 22-gauge needle by acquiring a larger amount of tissue sample. However, there has been no well-designed comparative study for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) with a 19-gauge aspiration needle. We conducted this study to compare the diagnostic accuracy of EUS-FNA using a 19-gauge aspiration needle with that using a 22-gauge aspiration needle in patients with solid pancreatic/peripancreatic mass. METHODS: From March 2007 to April 2008, a total of 117 patients (60 in a 19-gauge needle group and 57 in a 22-gauge needle group) with solid pancreatic/peripancreatic mass were included. EUS-FNA was performed using the standard technique without an on-site cytopathologist. A single, blinded cytopathologist retrospectively evaluated each set of slides. RESULTS: The diagnostic accuracy by intention-to-treat analysis was not significantly different (19G: 86.7% vs. 22G: 78.9%, P=0.268). However, the diagnostic accuracy by per-protocol analysis, excluding technical failures, was significantly higher in the 19-gauge needle group (94.5% vs. 78.9%, P=0.015). In the treatment-received group that included crossover cases, although the diagnostic accuracy in all cases was not significantly different (86.1% vs. 76.9%, P=0.164), that of body/tail lesion (95.0% vs. 76.7%, P=0.031) and technically successful cases (93.9% vs. 78.1%, P=0.006) were significantly higher in the 19-gauge needle group. On sample quality analysis, the amount of cellular material obtained was significantly higher in the 19-gauge needle group (P=0.033). CONCLUSIONS: EUS-FNA with a 19-gauge aspiration needle may be a valuable method for the diagnosis of pancreatic/peripancreatic masses when an on-site cytopathologist is not available.

EUS-guided cholecystoenterostomy with single-step placement of a 7F double-pigtail plastic stent in patients who are unsuitable for cholecystectomy: a pilot study (with video).

BACKGROUND: Although the definitive therapy of acute cholecystitis is cholecystectomy, nonsurgical treatment such as percutaneous cholecystostomy could be indicated in patients who are unsuitable candidates for cholecystectomy. EUS-guided cholecystoenterostomy with a plastic stent and/or nasobiliary drainage has been proposed as an alternative effective treatment for these patients. OBJECTIVE: We conducted this study to evaluate the technical feasibility, safety, usefulness, and follow-up results of EUS-guided cholecystoenterostomy with single-step placement of a plastic stent for patients with acute cholecystitis who are unsuitable candidates for cholecystectomy. DESIGN: A prospective feasibility study with a case series. SETTING: Tertiary teaching hospital. PATIENTS: Eight consecutive patients diagnosed with acute cholecystitis who were poor candidates for surgery. INTERVENTIONS: EUS-guided cholecystoenterostomy with single-step placement of a 7F double-pigtail plastic stent. MAIN OUTCOME MEASUREMENTS: Technical success, clinical resolution of acute cholecystitis, procedure-related complications, and recurrence of cholecystitis. RESULTS: Technical success and clinical resolution were achieved in all patients (100% [8/8] as intent to treat). A transduodenal approach was used for 7 patients and a transgastric approach for 1 patient. One patient showed self-limited pneumoperitoneum, and bile peritonitis occurred in 1 patient. One patient showed distal stent migration without bile leakage 3 weeks after stent insertion. During follow-up periods (median 186 days; range 22-300 days), cholecystitis did not recur in any patients. LIMITATIONS: Small number of patients. CONCLUSION: EUS-guided cholecystoenterostomy with single-step placement of a 7F double-pigtail plastic stent may be a feasible and useful alternative in patients with acute cholecystitis who are unsuitable candidates for cholecystectomy.

The combined measurement of total serum IgG and IgG4 may increase diagnostic sensitivity for autoimmune pancreatitis without sacrificing specificity, compared with IgG4 alone.

OBJECTIVES: Until now, there was no international consensus on the diagnostic criteria for autoimmune pancreatitis (AIP). As for serologic criteria, the HISORt criteria use elevated immunoglobulin (Ig) G4 alone, whereas the Asian diagnostic criteria include elevations of total IgG or IgG4, or the presence of autoantibodies. This study was mainly aimed at determining whether the combined measurement of total IgG and IgG4 could increase the diagnostic sensitivity for AIP while maintaining specificity, compared with IgG4 alone. Another aim was to determine the utility of autoantibodies to diagnose AIP. METHODS: We prospectively measured total serum IgG and IgG4 together in 82 consecutive patients with AIP, and seropositivity was defined as elevation of either total IgG or IgG4. To evaluate specificity in the differentiation of AIP from pancreatic cancer, total serum IgG and IgG4 were prospectively measured in 110 patients with pancreatic cancer. Also, the detection rates of antinuclear antibody (ANA) and rheumatoid factor (RF) were retrospectively reviewed in patients with AIP. RESULTS: In patients with AIP, the sensitivity of IgG4 (> or = 135 mg/dl) was 52.5% (43/82), significantly higher than that (46.3%, 38/82) of total IgG (> or = 1,800 mg/dl) (P<0.05). The sensitivity of combined measurement of total IgG and IgG4 for AIP was 68.3% (56/82), significantly higher than that of IgG4 alone (P<0.05). The specificity of total IgG and IgG4 in the differentiation of AIP from pancreatic cancer was 96.4 and 99.1%, respectively. The specificity of combined measurement of total IgG and IgG4 was 95.5%, and it was not significantly different from that of IgG4 alone (P=0.125). The sensitivity of ANA (> or = 1:80) and RF was 24.4% (19/78) and 20.3% (13/64), respectively. All but one patient who had positive results for ANA or RF also showed elevations of either total IgG or IgG4, respectively. CONCLUSIONS: The combined measurement of total serum IgG and IgG4 may increase diagnostic sensitivity without sacrificing specificity, compared with IgG4 alone. However, the measurement of ANA or RF may show no additional benefit when combined with total serum IgG and IgG4.

[A case of fulminant hepatic failure secondary to hepatic metastasis of small cell lung carcinoma].

Although liver metastasis is commonly found in cancer patients, fulminant hepatic failure secondary to diffuse cancer infiltration into the liver is rare. Liver metastasis-induced fulminant hepatic failure has been reported in patients with primary cancer of the gastrointestinal tract, breast and uroepithelium, and in patients with melanoma and hematologic malignancy. Small cell lung cancer is so highly invasive that hepatic metastasis is common, but rapid progression to fulminant hepatic failure is extremely rare. We report here on a case of a patient who died because of rapid progression to fulminant hepatic failure as a result of hepatic metastasis of small cell lung carcinoma.

[Hemobilia from pancreatic arteriovenous malformation: successful treatment with transportal coil embolization of draining veins].

Pancreatic arteriovenous malformations (AVM) are extremely rare diseases frequently complicated by gastrointestinal hemorrhage. While surgical resection of affected lesion is preferred for the treatment of pancreatic AVM, angiographic intervention can be used as an alternative treatment, especially in surgically high-risk patients. We experienced a patient with pancreatic AVM manifested by hemobilia and biliary sepsis. Superior mesenteric and common hepatic arteriography showed pancreaticoduodenal AVM composed of nidus supplied by numerous fine feeding arteries and of draining veins encircling the common bile duct (CBD). Hemobilia was controlled by transportal coil embolization of draining veins of AVM around the CBD. Herein, we report this case with the review of literatures.