Macroscopic qualitative evaluation of solid pancreatic lesion specimens from endoscopic ultrasound-guided fine needle aspiration/biopsies.

OBJECTIVES: To pathologically clarify the macroscopic features of endoscopic ultrasound-guided fine needle aspiration/biopsy (EUS-FNA/B) specimens in representative pancreatic diseases and establish tissue-handling standards based on the macroscopic findings. METHODS: We gathered EUS-FNA/B specimens of cases at our institution with the final diagnoses of pancreatic ductal adenocarcinoma (PDAC, n = 172), neuroendocrine tumor (NET, n = 19), and chronic inflammatory lesion (CIL, n = 24) including autoimmune pancreatitis. We classified the specimens' macroscopic features in five categories (red strings, mixed-red-and-white strings, white cores, gray tissues, gelatinous tissues) and compared the specimens' features on cytological and histological slides. RESULTS: All five macroscopic categories were observed in variable combinations in the PDACs; red strings and white cores predominated in the NETs and CILs. White cores represented neoplastic (PDAC, NET) or lesion (CIL) tissues. Mixed-red-and-white strings were unique to PDACs and contained cancerous cells. Neoplastic cells were numerous in red strings in NETs but not the other groups. Gray and gelatinous tissues represented necrosis and mucin, respectively, and the former were almost exclusively observed in PDACs. Red strings, mixed-red-and-white strings, and white cores were suitable for histological examination, whereas gray and gelatinous tissues were suitable for cytological examination. The white cores, mixed-red-and-white strings, and gelatinous tissues may be composed of non-neoplastic tissues such as contaminated gastrointestinal epithelium. In seven PDACs, although white cores were obtained, a histological diagnosis was not established. CONCLUSIONS: Macroscopic evaluations of EUS-FNA/B can enable the identification of specimen components and a possible diagnosis. They also contribute to the selection of the optimal tissue-handling methods.

Bilateral verses bilateral with tri-segmental endoscopic drainage using metal stents for high-grade malignant hilar biliary obstructions: A multicenter, randomized controlled trial: BRAVE study (BRAVE study).

INTRODUCTION: Bilateral endoscopic drainage with self-expanding metallic stent (SEMS) can be used to manage hilar malignant biliary obstruction (HMBO) more effectively in comparison to unilateral drainage. An increased drainage area is predicted to prolong stent patency and patient survival. However, few reports have described the utility of trisegmental drainage and the benefits of using trisegmental drainage remain unknown. Thus, we launched a randomized clinical trial (RCT) to compare the clinical outcomes between bilateral and trisegmental drainage using SEMSs in patients with high-grade HMBO. METHODS AND ANALYSIS: This study was conducted as a multicenter randomized control trial (RCT) in 8 high-volume medical centers in Japan, and will prove the non-inferiority of bilateral drainage to trisegmental drainage. Patients with unresectable HMBO with Bismuth type IIIa or IV who pass the inclusion and exclusion criteria will be randomized to receive bilateral or trisegmental drainage at a 1:1 ratio. At each center, the on-site study investigators will obtain informed consent from the candidates, and will use an electronic data capture system (REDCap) to input necessary information, and register candidates with the registration secretariat. The primary endpoint is the rate of non-recurrent biliary obstruction (RBO) at 180 days after SEMSs placement. A -10% non-inferiority margin is assumed in the statistical analysis of the primary endpoint. Secondary endpoints include the rate of technical and clinical success, time to recurrent biliary obstruction (TRBO), causes of RBO, procedure-related adverse events (AEs), procedure time, TRBO with or without endoscopic sphincterotomy, overall survival, and the technical and clinical success rates at reintervention. DISCUSSION: If the non-inferiority of bilateral drainage is demonstrated, it is predicted that the procedure time will be shortened and the medical cost will be reduced, which will be beneficial to the patient and the medical economy. TRIAL REGISTRATION: Registered in Japan Registry of Clinical Trial-Registration (trial number. jRCTs062220038). This version number 1. Protocol dated Jun 23, 2022.

Fatal Immune Checkpoint Inhibitor-related Pancreatitis.

We herein report a case of fatal pancreatitis induced by an immune checkpoint inhibitor. A 62-year-old man with cancer of unknown primary was treated with pembrolizumab. After 12 cycles, immune-related pneumonitis developed and was treated with prednisolone. Three months later, pancreatitis developed, which was successfully treated with hydration and protease inhibitors. Eight months later, another attack of pancreatitis occurred, which did not respond to therapy, including high-dose corticosteroids, and he eventually died. This is the first report describing fatal immune checkpoint inhibitor-related pancreatitis. Despite the rarity of this complication, attention should be paid to its potential severity and treatment.

Effectiveness, safety, and factors associated with the clinical success of endoscopic biliary drainage for patients with hepatocellular carcinoma: a retrospective multicenter study.

BACKGROUND: Only a few reports have assessed the effectiveness of endoscopic biliary drainage (EBD) in hepatocellular carcinoma (HCC) patients with obstructive jaundice and liver dysfunction. METHODS: This was a retrospective study based on the clinical databases from the Okayama University Hospital and 10 affiliated hospitals. All patients received EBD for jaundice or liver dysfunction. The indication for EBD was aggravation of jaundice or liver dysfunction with intrahepatic bile duct (IHBD) dilation. The technical and clinical success rate, complications, factors associated with clinical failure, and survival duration were evaluated. RESULTS: A total of 107 patients were enrolled in this study. Technical success was achieved in 105 of 107 patients (98.1%). Clinical success was achieved in 85 of 105 patients (81%). Complications related to endoscopic retrograde cholangiography (ERC) occurred in 3 (2.8%) patients. Child-Pugh class C (odds ratio 3.90, 95% confidence interval [CI] 1.47-10.4, p = 0.0046) was the only factor associated with clinical failure, irrespective of successful drainage. The median survival duration was significantly longer in patients with clinical success than in those without clinical success (5.0 months vs. 0.93 months; hazard ratio [HR] 3.2, 95% CI 1.87-5.37). HCC Stage I/II/III (HR 0.57, CI 0.34-0.95, p = 0.032), absence of portal thrombosis (HR 0.52, CI 0.32-0.85, p = 0.0099), and clinical success (HR 0.39, CI 0.21-0.70, p = 0.0018) were significant factors associated with a long survival. CONCLUSIONS: EBD for obstructive jaundice and liver dysfunction in patients with HCC can be performed safely with a high technical success rate. Clinical success can improve the survival duration, even in patients expected to have a poor prognosis. TRIAL REGISTRATION: Retrospectively registered.

Comparison of anticoagulants and risk factors for bleeding following endoscopic sphincterotomy among anticoagulant users: Results from a large multicenter retrospective study.

BACKGROUND AND AIM: Bleeding is an inevitable and often severe complication after endoscopic sphincterotomy (EST). We aimed to investigate the factors associated with post-EST bleeding in patients treated with anticoagulants. METHODS: The data of patients who underwent EST at 15 hospitals between July 2015 and June 2017 were extracted. We investigated the incidence of post-EST bleeding and risk factors for bleeding in patients treated with anticoagulants. RESULTS: One hundred forty-nine patients undergoing EST who met the inclusion criteria were included in this study. The total-EST bleeding (bleeding occurring during or after EST) rate did not differ between the heparin replacement (8.0%, 6/75) and continuation (16.6%, 2/12; P = 0.37) groups of warfarin users. The total-EST-bleeding rate in the heparin replacement group (12.9%, 4/31) was significantly higher than that in the continuation group (0%, 0/31; P = 0.016) in direct oral anticoagulant (DOAC) users. The rate of total-EST bleeding with continuation of DOAC (0%, 0/31) was significantly lower with continuation of warfarin (16.6%, 2/12; P = 0.021). During-EST bleeding (bleeding occurring during EST) (P = 0.0083) and precut (P = 0.033) were significant risk factors for post-EST bleeding in all 149 patients. Heparin replacement was only a significant risk factor for total-EST bleeding (P = 0.033) in DOAC users. CONCLUSION: Heparin replacement was a significant risk factor for post-EST bleeding in DOAC users; however, there was no significant difference between the bleeding rate of heparin replacement and that of continuation groups in patients taking warfarin. During EST and precut were significant risk factors for post-EST bleeding in all patients treated with anticoagulants.

Continuous regional arterial infusion versus intravenous administration of the protease inhibitor nafamostat mesilate for predicted severe acute pancreatitis: a multicenter, randomized, open-label, phase 2 trial.

BACKGROUND: Continuous regional arterial infusion (CRAI) of protease inhibitor nafamostat mesilate (NM) is used in the context of predicted severe acute pancreatitis (SAP) to prevent the development of pancreatic necrosis. Although this therapy is well known in Japan, its efficacy and safety remain unclear. METHODS: This investigator-initiated and -driven, multicenter, open-label, randomized, controlled trial (UMIN000020868) enrolled 39 patients with predicted SAP and low enhancement of the pancreatic parenchyma on computed tomography (CT). Twenty patients were assigned to the CRAI group, while 19 served as controls and were administered NM at the same dose intravenously (IV group). The primary endpoint was the development of pancreatic necrosis as determined by CT on Day 14, judged by blinded central review. RESULTS: There was no difference between the CRAI and IV groups regarding the percentages of participants who developed pancreatic necrosis (more than 1/3 of the pancreas: 25.0%, range 8.7-49.1% vs. 15.8%, range 3.4-39.6%, respectively, P = 0.694; more than 2/3 of the pancreas: 20%, range 5.7-43.7% vs. 5.3%, range 0.1-26.0%, respectively, P = 0.341). The early analgesic effect was evaluated based on 24-h cumulative fentanyl consumption and additional administration by intravenous patient-controlled analgesia. The results showed that the CRAI group used significantly less analgesic. There were two adverse events related to CRAI, namely bleeding and splenic infarction. CONCLUSIONS: CRAI with NM did not inhibit the development of pancreatic necrosis although early analgesic effect of CRAI was superior to that of IV. Less-invasive IV therapy can be considered a viable alternative to CRAI therapy.

Analysis of Prognostic Factors in Pancreatic Metastases: A Multicenter Retrospective Analysis.

OBJECTIVES: Pancreatic metastases (PMs) account for 1% to 2% of pancreatic tumors, and their prognostic significance is poorly defined. We evaluated the incidence and clinical characteristics of primary tumors and defined prognostic factors. METHODS: This retrospective study of 39 Japanese tertiary referral hospitals (January 2005 to August 2015) analyzed patient and tumor characteristics and survival time. Kaplan-Meier analysis and Cox proportional hazards models were applied to evaluate overall survival and prognostic factors, respectively. RESULTS: We enrolled 159 patients with a pathologic diagnosis of PM. The most common primary tumor was renal cell carcinoma (38.4%), followed by lung cancer (24.5%), colorectal cancer (11.3%), and sarcoma (6.3%). Eight patients were lost during follow-up, and 151 patients were included for statistical analysis. Median overall survival was 43.0 months, and the 5-year survival rate was 42.6%. Multivariate analysis identified 3 independent prognostic factors: extrapancreatic metastasis (hazard ratio, 2.13; 95% confidence interval, 1.11-4.07; P = 0.02), tumor-related symptoms at diagnosis (hazard ratio, 5.39; 95% confidence interval, 2.92-9.91; P < 0.001), and pathologic diagnosis of primary tumors (P < 0.001). CONCLUSIONS: Treatment strategies and prognoses for PMs completely differ according to the primary tumor type. A definitive pathologic diagnosis of PMs is essential for selecting the appropriate treatment.

Factors predicting through-the-scope gastroduodenal stenting outcomes in patients with gastric outlet obstruction: a large multicenter retrospective study in West Japan.

BACKGROUND AND AIMS: Endoscopic gastroduodenal stenting for malignant gastric outlet obstruction recently has become more effective, but the factors that predict gastroduodenal stenting outcomes are poorly defined. This multicenter retrospective cohort study evaluated the clinical outcomes of gastroduodenal stenting in malignant gastroduodenal obstruction and identified factors predicting clinical ineffectiveness, stent dysfunction, and adverse events. METHODS: All consecutive patients with malignant gastroduodenal obstruction who underwent through-the-scope gastroduodenal stenting from 2009 to 2014 at 4 tertiary-care medical centers were identified. Clinically ineffective stenting was defined as symptom recurrence and a gastric outlet obstruction scoring system (GOOSS) score <2. RESULTS: Of the 278 patients (mean age ± standard deviation [SD] 71.7 ± 11.4 years), 121 (43.5%) and 87 (31.3%) had pancreatic and gastric cancer, respectively. Technical success was achieved in 277 patients (99.6%). GOOSS scores rose from 0.5 ± 0.6 to 2.6 ± 0.8. Stenting was ineffective in 32 patients (12.6%). Stent dysfunction that caused symptom recurrence during follow-up developed in 46 patients (16.6%). Adverse events occurred in 49 patients (17.7%). Three or more stenosis sites (odds ratio [OR] = 6.11; P < .01) and Karnofsky performance scores ≤50 (OR = 6.63; P < .01) predicted clinical ineffectiveness. Karnofsky performance scores ≤50 predicted stent dysfunction (hazard ratio [HR] = 3.63; P < .01). Bile duct stenosis (HR = 9.55; P = .02) and liver metastasis (HR = 9.42; P < .01) predicted stent overgrowth. Covered stent predicted stent migration (HR = 12.63; P < .01). Deployment of 2 stents predicted perforation (HR = 854.88; P < .01). CONCLUSIONS: Through-the-scope gastroduodenal stenting tended to be ineffective in patients with poor performance status and long stenosis sites. Stent dysfunction occurred more frequently in patients with poorer performance status. Deployment of 2 stents was a risk factor for perforation. Identification of these risk variables may help yield better gastroduodenal stenting outcomes.

Establishment of a serum IgG4 cut-off value for the differential diagnosis of IgG4-related sclerosing cholangitis: a Japanese cohort.

BACKGROUND AND AIM: IgG4-related sclerosing cholangitis (IgG4-SC) must be precisely distinguished from primary sclerosing cholangitis and cholangiocarcinoma (CC) because the treatments are completely different. However, the pathological diagnosis of IgG4-SC is difficult. Therefore, highly specific non-invasive criteria such as serum IgG4 should be established. This study established a cut-off for serum IgG4 to differentiate IgG4-SC from respective controls using serum IgG4 levels measured in Japanese centers. METHODS: A total of 344 IgG4-SC patients were enrolled in this study. As controls, 245, 110, and 149 patients with pancreatic cancer, primary sclerosing cholangitis, and CC, respectively, were enrolled. IgG4-SC patients were classified into three groups: type 1 (stenosis only in the lower part of the common bile duct), type 2 (stenosis diffusely distributed throughout the intrahepatic and extrahepatic bile ducts), and types 3 and 4 (stenosis in the hilar hepatic region) with 246, 56, and 42 patients, respectively. Serum IgG4 levels were compared, and the cut-offs were established. RESULTS: The cut-off obtained from receiver operator characteristic curves showed similar sensitivity and specificity to that of 135 mg/dL when all IgG4-SC and controls were compared. However, a new cut-off value was established when subgroups of IgG4-SC and controls were compared. A cut-off of 182 mg/dL can increase the specificity to 96.6% (4.7% increase) for distinguishing types 3 and 4 IgG4-SC from CC. A cut-off of 207 mg/dL might be useful for completely distinguishing types 3 and 4 IgG4-SC from all CC. CONCLUSIONS: Serum IgG4 is useful for the differential diagnosis of IgG4-SC and controls.

Management of occluded metallic stents in malignant hilar biliary stricture.

BACKGROUND/AIMS: Little is known about the management of occluded multiple metallic stent (MS) deployed in malignant hilar biliary strictures (HBS). The purpose of this study was to evaluate the endoscopic management of occluded multiple MSs deployed in HBS. METHODOLOGY: Fifty-five patients with unresectable biliary tract carcinoma had multiple MSs inserted due to HBS. The endoscopic intervention through the duodenal papilla was performed on 30 cases that had MS occlusion. The procedure success rate, the survival time after the procedure and the number of endoscopic interventions before death were analyzed, retrospectively. RESULTS: The causes of MS obstruction were tissue ingrowth (n=20), sludge (n=7), tumor overgrowth (n=2), and hemobilia (n=1). Endoscopic cleaning or deployment of plastic stents or metallic stents was performed on these patients and was successfully accomplished only via the transpapillary approach. The survival time after MS obstruction was 219 days. The median number of endoscopic interventions before death was 3. The median interval of endoscopic intervention after the first plastic stent occlusion was 84 days. CONCLUSIONS: Our long-term data regarding the endoscopic management of occluded MSs deployed in malignant hilar biliary strictures are acceptable although the patency time of plastic stents deployed after MS occlusion was relatively short.

Monitoring of CA19-9 and SPan-1 can facilitate the earlier confirmation of progressing pancreatic cancer during chemotherapy.

BACKGROUND: Measurement of objective response to chemotherapy using imaging modalities is sometimes difficult in pancreatic cancer (PC). We aimed to verify whether monitoring of serum tumor markers (TMs), namely carcinoembryonic antigen, CA19-9, DUPAN-2, SPan-1, can facilitate earlier confirmation of treatment failure. METHODS: Monitoring of serum TMs and computed tomography were performed every 4 weeks until progression of disease in 90 patients with PC undergoing gemcitabine therapy. In Group A (January 2006-October 2007), we analyzed the fluctuation rates of TMs with high pretreatment positive rates, and defined the criteria of progressive disease under TM monitoring (TM-PD). In Group B (November 2007-October 2008), we calculated the time to progression (TTP) under this TM-PD criteria, which was compared with the TTP under the RECIST criteria. RESULTS: CA19-9 and SPan-1 had the highest pretreatment positive rates: 83% and 90%, respectively. In Group A (CA19-9, n = 38; SPan-1, n = 36), TM-PD criteria were defined as follows: fluctuation rates were ≥25% for a month or ≥10% for 2 consecutive months in CA19-9, and ≥10% for a month in SPan-1. In Group B (CA19-9, n = 18; SPan-1, n = 17), under these criteria, one-month earlier confirmation of treatment failure was feasible in 61% by CA19-9 and 59% by SPan-1. Furthermore, the combination could facilitate this determination in 72% (35/49), significantly better than CA19-9 alone (P = 0.004). CONCLUSION: Monitoring of serum CA19-9 and SPan-1 is helpful for earlier confirmation of treatment failure during gemcitabine therapy in PC.

A 4-week versus a 3-week schedule of gemcitabine monotherapy for advanced pancreatic cancer: a randomized phase II study to evaluate toxicity and dose intensity.

BACKGROUND: This randomized phase II study compared the efficacy and toxicity between 4-week and 3-week schedules of gemcitabine monotherapy in advanced pancreatic cancer. METHODS: Patients with advanced pancreatic cancer were randomly assigned to either a 4-week schedule (gemcitabine at 1000 mg/m² as a 30-min infusion weekly for 3 consecutive weeks every 4 weeks) or a 3-week schedule (gemcitabine at 1000 mg/m² as a 30-min infusion weekly for 2 consecutive weeks every 3 weeks). The primary endpoint was the compliance rate during the first 8 weeks between the two groups. RESULTS: A total of 90 patients were enrolled. The compliance rate during the first 8 weeks was the same (53.3%). For the 4- and 3-week schedules, the tumor response rates were 14.2 and 17.1% (p = 0.92), median progression free survival was 112 and 114 days (p = 0.82), and median overall survival was 206 and 250 days (p = 0.84), respectively. Grade 3-4 neutropenia was the major adverse event in both schedules: 37.7 and 35.5% (p = 0.82). In contrast, thrombocytopenia (platelet count <70000/mm³) was significantly higher for the 4-week schedule: 26.6 and 4.4% (p = 0.008). The mean received dose intensity was equal: 588 and 550 mg/m²/week (p = 0.14). CONCLUSIONS: The 3-week schedule of gemcitabine did not improve the compliance rate during 8 weeks compared with the 4-week schedule, but it attained a comparable efficacy with lower toxicity. Further investigation will be needed to introduce it into daily practice. CLINICAL TRIAL REGISTRATION NUMBER: UMIN ID 974.

Combined duodenal stent placement and endoscopic ultrasonography-guided biliary drainage for malignant duodenal obstruction with biliary stricture.

Patients with malignant pancreatobiliary neoplasm sometimes manifest duodenal obstruction and biliary stricture synchronously or metachronously. In this paper, we reviewed our experience with and technique for combined endoscopic duodenal stent placement and endoscopic ultrasonography (EUS)-guided biliary drainage. Between May 2007 and September 2009, this combined technique was performed on seven patients with distal biliary strictures and duodenal obstructions. The clinical success rate of the procedure, complications, patency periods of duodenal stents and patency periods of biliary stents were retrospectively evaluated. Clinical success was achieved in all seven cases for both procedures. Complications related to EUS-biliary drainage, namely localized peritonitis due to bile leakage, occurred in two cases. Both patients recovered without additional interventions. Occlusion of a duodenal stent was observed in one patient, but additional intervention could not be performed due to sepsis. Occlusion of both a duodenal stent and a biliary stent was also observed in one patient, and this was resolved with the insertion of an additional duodenal stent and a biliary stent exchange. In conclusion, combined duodenal stent placement and EUS-guided biliary drainage is a therapeutic option in case of failed endoscopic retrograde cannulation of malignant strictures with a malignant duodenal obstruction.

Single-pattern convergence of K-ras mutation correlates with surgical indication of intraductal papillary mucinous neoplasms.

OBJECTIVES: One or more patterns of 6 K-ras mutations are detected in cells from the pancreatic juice of patients with intraductal papillary mucinous neoplasms (IPMNs). We investigated whether these mutations are associated with malignant progression. METHODS: Between January 2002 and December 2007, 53 patients with IPMN were subjected to collection of pure pancreatic juice to evaluate K-ras mutation. According to the histological and radiological findings, the IPMNs were classified into 4 groups: carcinoma group, adenoma group, high-risk group, and low-risk group. We retrospectively investigated the mutation with these groups. RESULTS: In patients with a positive K-ras mutation, a single pattern of K-ras mutation was observed in 80% (8/10) of the carcinoma group, in 71% (5/7) of the adenoma group, in 40% (2/5) of the high-risk group, and in 38% (8/21) of the low-risk group. The rate of a single pattern of K-ras mutation decreased in a stepwise order (P = 0.017). The incidence of a single pattern of K-ras mutation was significantly higher in the patients who received surgical therapy (75%, 12/16) than in those who did not (38%, 10/26; P = 0.033). CONCLUSIONS: The present study suggests that the single-clonal convergence of K-ras mutation is associated with the malignant progression of IPMNs.

Obstructive jaundice at the initial presentation in small-cell lung cancer.

Obstructive jaundice sometimes may develop in association with advanced small-cell lung cancer (SCLC); however, SCLC initially presenting with obstructive jaundice is rare. This report presents the cases of two SCLC patients with obstructive jaundice at the initial diagnosis. A 64-year-old male presented with obstructive jaundice due to a tumor at the head of the pancreas. He was diagnosed with SCLC by transbronchial biopsy from a lung tumor in the left upper lobe. Another 74-year-old male was admitted with jaundice due to a tumor in the porta hepatis. He was also diagnosed with SCLC by a fine-needle aspiration biopsy of a lung tumor in the left lower lobe. Both cases were successfully treated with systemic chemotherapy after endoscopic retrograde biliary drainage.

Nonprevention of post-endoscopic retrograde cholangiopancreatographic pancreatitis by pancreatic stent after aspiration of pure pancreatic juice in patients with intraductal papillary mucinous neoplasms of the pancreas.

OBJECTIVES: The objective of this study was to evaluate the efficacy of a pancreatic stent regarding the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis after aspiration of pure pancreatic juice in patients with intraductal papillary mucinous neoplasms. METHODS: A retrospective study was made to assess the outcome in 121 consecutive patients with intraductal papillary mucinous neoplasms who underwent endoscopic aspiration of pure pancreatic juice for cytologic examination between July 2001 and October 2007. From July 2001 to March 2004, 58 patients did not undergo pancreatic stent insertion (the no-stent [nS] group). The remaining 63 patients did undergo stent insertion (stent [S] group). RESULTS: The overall incidences of post-ERCP pancreatitis was 11 (9.1%). The incidences of post-ERCP pancreatitis in the S and nS groups were 8 (12.7%) and 3 (5.2%; P = 0.21), respectively. In the male patients and the patients with a smaller diameter of the main pancreatic ducts, post-ERCP pancreatitis was seen more frequently in those in the S group (13% and 21%, respectively) than in those in the nS group (0% and 0%, respectively; P = 0.04, 0.03). CONCLUSIONS: The pancreatic stent did not seem to decrease the incidence of post-ERCP pancreatitis in patients with intraductal papillary mucinous neoplasms. Furthermore, the pancreatic stent seems to be potentially detrimental in male patients and in patients with small-diameter main pancreatic ducts.

Prevention of biliary complication in radiofrequency ablation for hepatocellular carcinoma-Cooling effect by endoscopic nasobiliary drainage tube.

BACKGROUND AND STUDY AIMS: Biliary stricture after radiofrequency ablation (RFA) for nodules of hepatocellular carcinoma (HCC) close to major bile ducts sometimes causes septic complications and liver failure. Therefore, it may require interventional drainage for decompression during the follow-up period. The purpose of this study is to clarify the feasibility and safety of bile duct cooling using an endoscopic nasobiliary drainage (ENBD) tube in RFA for HCC close to major bile ducts. PATIENTS AND METHODS: Between August 2003 and July 2007, 14 consecutive patients (14 nodules) undergoing RFA with cooling by an ENBD tube for HCCs close to major bile ducts were enrolled in this study. We infused chilled saline solution via the ENBD tube at 1ml/s to prevent heat damage during RFA. As controls, 11 patients (13 nodules) undergoing RFA without cooling close to major bile ducts between April 2001 and August 2003 were reviewed. The major outcomes for evaluation were biliary complications and the secondary outcome was local tumor recurrence. RESULTS: There were no significant differences in tumor recurrence between the two groups. However, the rate of biliary complications was significantly lower in the cooling group than in the non-cooling group (0% vs. 39%, P=0.02). CONCLUSIONS: Cooling of bile ducts via an ENBD tube can prevent biliary complications induced by RFA of HCC close to major bile ducts without increasing local recurrence. This technique increases indication of RFA in difficult cases.

Long-term outcomes of endoscopic management for biliary strictures after living donor liver transplantation with duct-to-duct reconstruction.

Biliary strictures after living donor liver transplantation (LDLT) with duct-to-duct (D-D) reconstruction are associated with postoperative morbidity and mortality. The aims of this study were to evaluate the long-term outcomes of endoscopic deployment of plastic stents, and to investigate factors associated with the stent deployment failure. Between April 2001 and May 2007, 96 patients received LDLT with D-D reconstruction at Okayama University Hospital. Among them, 41 patients (43%) had anastomotic biliary strictures, and all were referred first for endoscopic retrograde cholangiography (ERC). When deployment was unsuccessful, a percutaneous transhepatic procedure was employed. Successful stent deployment was achieved in 35 out of total 41 patients (85%) by both procedures. Among the 35 patients, 28 had their stents removed as a result of strictures resolution. Eight patients underwent ERC and repeated stent deployment as a result of recurrence of the strictures. Finally, 21 out of 41 (51%) patients with biliary stricture were completely treated by endoscopic therapy during the observation period (median 873 days: range 77-2060). By multivariate analysis, biliary leakage was associated with stent deployment failure. Endoscopic deployment of plastic stents is a first-line therapy for patients with biliary stricture after LDLT.

Quantitative assessment of technical proficiency in performing needle-knife precut papillotomy.

BACKGROUND: Although needle-knife precut papillotomy (NKPP) is considered a useful alternative for achieving selective biliary cannulation, controversy remains regarding the technical proficiency needed to perform the procedure and its safety. This study evaluated whether procedural experience with NKPP predicted either successful cannulation or the development of complications. METHODS: This study retrospectively investigated 104 patients, out of 589 consecutive patients with native papillary, who underwent NKPP performed by a single endoscopist between October 2002 and July 2006. To demonstrate changes in NKPP, the 104 patients were divided chronologically into two groups according to periods: period A (October 2002 to September 2004) and period B (October 2004 to July 2006). RESULTS: Of the 104 consecutive patients who underwent NKPP, 41 (41/267, 15%) were treated in period A and 63 (63/322, 20%) in period B. There was no significant difference in the overall success rate between periods A (90%) and B (98%) (p = 0.08). However, the initial success rate was higher in period B (95%) than in period A (80%) (p < 0.05). The complication rates were not significantly different between the two groups (10% vs 16%; p = 0.56). Although all complications involved pancreatitis, severe pancreatitis was not observed. CONCLUSION: Whereas the initial success rate for NKPP can increase with procedural experience, the complication rate does not seem to decrease. Furthermore, the need for NKPP does not appear to decrease with increasing endoscopic retrograde cholangiopancreatography (ERCP) experience.