Impact of temperature-controlled endobiliary radiofrequency ablation for inoperable hilar cholangiocarcinoma: A propensity score-matched analysis.

Background and study aims Endobiliary radiofrequency ablation (RFA) can be an effective palliative treatment, but few studies have evaluated its outcomes for malignant obstruction in the hilar bile duct, which has a thin wall and complex duct-vascular contacts. We evaluated the efficacy and safety of temperature-controlled endobiliary RFA, which can reduce the risk of unintentional thermal injury by maintaining the temperature of the ablation segment, in the treatment of inoperable hilar cholangiocarcinoma (CCA). Patients and methods After propensity score matching, 64 patients with inoperable hilar CCA were categorized to the RFA + stent group (endobiliary RFA with stenting; n=32) or stent-only group (stenting only; n=32). The evaluated outcomes were the median time to recurrent biliary obstruction (RBO), overall survival (OS), and adverse events (AEs). Results Technical success was achieved in all patients. The clinical success rate was 93.8% in the RFA + stent group and 87.5% in the stent-only group ( P =0.672). The median time to RBO was 242 days in the RFA + stent group and 168 days in the stent-only group ( P =0.031). The median OS showed a non-significant tendency to be higher in the RFA + stent group (337 versus 296 days; P =0.260). Overall AE rates were comparable between the two groups (12.5% vs 9.4%, P =1.000). Conclusions Temperature-controlled endobiliary RFA resulted in favorable stent patency without increasing the rate of AEs but it did not significantly increase OS in patients with inoperable hilar CCA (Clinical trial registration number: KCT0008576).

Comparison of disposable digital single-operator cholangioscopy versus direct peroral cholangioscopy for the diagnosis of intraductal superficial lesions of the bile duct.

BACKGROUND AND AIMS: Disposable digital single-operator cholangioscopy (D-SOC) and direct peroral cholangioscopy (D-POC) using an ultraslim endoscope are established POC modalities for the diagnosis and treatment of various biliary diseases. We compared the usefulness of D-SOC and D-POC for the diagnosis of intraductal superficial lesions of the bile duct (ISL-Bs). METHODS: In total, 38 consecutive patients with suspected biliary diseases who underwent both D-SOC and D-POC were enrolled. The primary outcome was the detection rate of the ISL-Bs, and the secondary outcomes were the technical success of POC and POC-guided forceps biopsy sampling (POC-FB), procedure time, visualization quality, and tissue adequacy. RESULTS: D-SOC had a higher technical success rate than D-POC but without a statistically significant difference (100% vs. 92.1%, P = 0.248). D-POC had a marginally higher ISL-B detection rate (34.2% vs. 28.9%, P = 0.683) and significantly higher visualization quality (P = 0.033). The mean procedure time was significantly shorter with D-SOC (11.00 ± 1.34 vs. 19.03 ± 2.95 min, P < 0.001). The technical success rate of POC-FB and tissue adequacy did not differ between the two techniques (D-SOC vs. D-POC: 81.8% vs. 84.6%, P = 0.693 and 77.8% vs. 90.9%, P = 0.566). CONCLUSIONS: Our results demonstrate that both POC systems are safe and useful for the detection, characterization, and diagnosis of minute ISL-Bs. While D-SOC displayed a shorter procedure time and a tendency for higher technical success rate, D-POC provided superior visualization quality, allowing detailed observation of the surface structure and microvascular patterns.

Usefulness of Direct Peroral Cholangioscopy Using a Multibending Ultraslim Endoscope for the Management of Intrahepatic Bile Duct Lesions (with Videos).

Background/Aims: : Peroral cholangioscopy (POC) has been used to assess intrahepatic duct (IHD) lesions but with a limited role. A new multibending (MB) ultraslim endoscope has been designed to improve POC performance. We evaluated the usefulness of POC using the MB ultraslim endoscope for the management of IHD lesions. Methods: : Between March 2017 and March 2020, 22 patients underwent direct POC using the MB ultraslim endoscope for IHD lesions documented by previous imaging or cholangiopancreatography. The primary outcome was technical success of POC, and secondary outcomes were technical success of POC-guided interventions, median procedure time, and POC-related adverse events. Results: : The technical success rate for POC using the MB ultraslim endoscope for IHD lesions was 95.5% (21/22). Free-hand insertion was successful in 95.2% (20/21). The overall technical success rate for POC-guided intervention was 100% (21/21), including nine diagnostic and 12 therapeutic procedures (eight direct stone removal and four intraductal lithotripsies). The median procedure time was 29 minutes (range, 9 to 79 minutes). There were no procedure-related adverse events. Conclusions: : Direct POC using the MB ultraslim endoscope allows direct visualization of IHD lesions and may be useful for diagnosis and therapeutic management in selected patients.

Endoscopic ultrasound-guided gallbladder drainage as a first approach for jaundice palliation in unresectable malignant distal biliary obstruction: Prospective study.

OBJECTIVES: Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in patients with distal malignant biliary obstruction (DMBO). Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. In a palliative setting the endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) could represent an easy and valid option. We performed a prospective study with a new EC-LAMS with the primary aim to assess the clinical success rate of EUS-GBD as a first-line approach to the palliation of DMBO. METHODS: In all, 37 consecutive patients undergoing EUS-GBD with a new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease >15% within 24 h and >50% within 14 days after EC-LAMS placement. RESULTS: The mean age was 73.5 ± 10.8 years; there were 17 male patients (45.9%). EC-LAMS placement was technically feasible in all patients (100%) and the clinical success rate was 100%. Four patients (10.8%) experienced adverse events, one bleeding, one food impaction, and two cystic duct obstructions because of disease progression. No stent-related deaths were observed. The mean hospitalization was 7.7 ± 3.4 days. Median overall survival was 4 months (95% confidence interval 1-8). CONCLUSION: Endoscopic ultrasound-guided gallbladder drainage with the new EC-LAMS is a valid option in palliative endoscopic biliary drainage as a first-step approach in low survival patients with malignant jaundice unfit for surgery. A smaller diameter EC-LAMS should be preferred, particularly if the drainage is performed through the stomach, to avoid potential food impaction, which could result in stent dysfunction.

Preliminary feasibility study of a new partially covered self-expandable metal stent with an anchoring flange for EUS-guided hepaticogastrostomy (with videos).

BACKGROUND AND AIMS: EUS-guided hepaticogastrostomy (EUS-HPG) has a risk of serious procedural adverse events (AEs), but few dedicated devices for EUS-HPG are available. We evaluated the feasibility of a new partially covered self-expandable metal stent (PCSEMS) with an anchoring flange for EUS-HPG. METHODS: The feasibility of a stent featuring a proximal radiopaque uncovered portion 1.5 cm in length and a distal anchoring flange 20 mm in diameter was evaluated in consecutive patients undergoing EUS-HPG for unresectable malignant biliary obstruction. Primary outcomes were the technical and clinical success of EUS-HPG, and secondary outcomes were AEs, recurrent biliary obstruction (RBO), reintervention for RBO, and the technical feasibility of peroral cholangioscopy (POC) through the stent in situ. RESULTS: EUS-HPG was performed in 24 patients with unresectable malignant biliary obstruction. The technical and clinical success rates of EUS-HPG were 100% (24/24) and 91.7% (22/24), respectively. AEs developed after EUS-HPG in 8.3% of patients (2/24, cholangitis). RBO developed in 29.2% of patients (7/24), with a median cumulative time to RBO of 6.7 months. The causes of RBO were sludge formation (n = 4), hyperplasia at an uncovered portion (n = 2), and nonocclusive cholangitis (n = 1). Reintervention for RBO had a 100% success rate (7/7), and POC through the stent in situ was technically feasible in 7 of 8 patients with a stent diameter of 10 mm. CONCLUSIONS: EUS-HPG with a new PCSEMS can alleviate malignant biliary obstruction after failed ERCP. The novel stent evaluated in this study may prevent stent-related AEs, including stent migration, and allow advanced endoscopic interventions through the HPG route.

Detection and endoscopic classification of intraductal neoplasms of the bile duct by peroral cholangioscopy with narrow-band imaging (with videos).

BACKGROUND AND AIMS: Indirect diagnostic modalities are unsatisfactory for detecting intraductal neoplasm of the bile duct (IN-B), which can be detected by peroral cholangioscopy (POC) with narrow-band imaging (NBI). We investigated the POC findings of IN-B and developed a feasible endoscopic classification system. METHODS: Four hundred seventy-one patients who underwent direct POC from April 2008 to July 2020 were enrolled. Intraductal superficial lesions of the bile duct (ISL-Bs) were classified according to surface structure and microvascular pattern on POC with NBI and correlated to histologic findings after POC-guided forceps biopsy sampling (POC-FB) or surgery. The primary outcome was the detection rate of IN-Bs, and the secondary outcomes were the associations of POC findings with IN-B, technical success rates of POC and POC-FB, and adverse events. RESULTS: Direct POC was successful in 458 of 471 patients (97.2%). Among the patients, 131 (27.8%) exhibited ISL-Bs. The technical success rate of POC-FB was 94.7% (124/131). Among the 124 patients who underwent POC-FB, IN-B was revealed in 54 (43.5%), for a detection rate of 11.8% (54/458). Papillary lesions (P = .041), nodular lesions (P = .044), and irregularly or regularly dilated and tortuous vessels (P = .004 and P = .006, respectively) were POC findings associated with IN-B. The area under the receiver-operating characteristic curve of the novel classification system was .899. CONCLUSIONS: POC with NBI can be useful for the detection of IN-Bs. Our novel classification system based on both surface structure and microvascular pattern may allow differentiation of IN-B from ISL-Bs.

Feasibility of Cholangioscopy Using Multibending Ultra-Slim Endoscope Through a Lumen-Apposing Metal Stent for Choledochoduodenostomy.

BACKGROUND AND AIMS: Endoscopic ultrasound (EUS) guided choledochoduodenostomy using a lumen-apposing metal stent (LAMS) allows access to the biliary system with a sufficiently large diameter stent. However, an appropriate endoscope for this purpose is required. We evaluated the feasibility of per-oral cholangioscopy (POC) using a multibending ultra-slim endoscope through a LAMS for EUS-guided choledochoduodenostomy. METHODS: Twelve patients who underwent EUS-guided choledochoduodenostomy, followed by POC via a LAMS, were enrolled. POC was performed with an multibending ultra-slim endoscope. The primary outcome was technical success, defined as examination of both hepatic ducts and either the distal common bile duct or stricture site within 10 min. The types of intervention and adverse events were also assessed. RESULTS: Technical success was achieved in all cases with the multibending ultra-slim endoscope. Narrow-band imaging endoscopy was performed in five cases (41.7%) and POC-guided targeted biopsy was performed in three cases (25.0%). Stone extraction during POC was performed in two patients (16.7%) and foreign body removal from the intrahepatic duct was performed in one patient. One patient underwent additional metal stent insertion under direct visualization. After POC, no stent migration or severe adverse events were seen in any case. CONCLUSIONS: POC using a multibending ultra-slim endoscope for diagnostic or therapeutic purposes can be performed effectively and safely through a LAMS after EUS-guided choledochoduodenostomy.

Efficacy of narrow-band imaging during peroral cholangioscopy for predicting malignancy of indeterminate biliary strictures (with videos).

BACKGROUND AND AIMS: Direct peroral cholangioscopy (POC) can be useful when combined with narrow-band imaging (NBI) to explore the etiologies of indeterminate biliary strictures. We evaluated the efficacy of NBI compared with that of conventional white-light imaging (WLI) during POC diagnosis of indeterminate biliary strictures. METHODS: Consecutive patients with indeterminate biliary strictures were enrolled from 2016 to 2019. The primary outcome was diagnostic accuracy, and secondary outcomes were technical success, adverse events, and visualization quality when predicting malignancy. RESULTS: Seventy-one patients underwent direct POC under NBI during targeted biopsy sampling. The strictures were successfully explored and adequate biopsy samples obtained in 67 of 71 patients (94.4%). In terms of visual impression, WLI and NBI afforded 75.0% and 87.5% sensitivity, 82.9 and 91.4% specificity, and 82.8 and 91.3% accuracy, respectively. The areas under the WLI and NBI receiver-operating characteristic curves were .80 and .96 (P = .01). Under NBI, the visualization quality of surface structures, microvessels, and lesional margins was higher than that under conventional WLI (P < .05). CONCLUSIONS: Direct POC under NBI effectively and accurately predicts malignancies of indeterminate biliary strictures. NBI effectively illuminated surface structures, microvessels, and lesional margins.

Utility of Direct Peroral Cholangioscopy Using a Multibending Ultraslim Endoscope for Difficult Common Bile Duct Stones.

Background/Aims: Treatment options for difficult bile duct stones are limited. Direct peroral cholangioscopy (POC)-guided lithotripsy may be an option. A newly developed multibending (MB) ultraslim endoscope has several structural features optimized for direct POC. We evaluated the utility of direct POC using an MB ultraslim endoscope for lithotripsy in patients with difficult bile duct stones. Methods: Twenty patients with difficult bile duct stones, in whom stone removal using conventional endoscopic methods, including mechanical lithotripsy, had failed were enrolled from March 2018 to August 2019. Direct POC-guided lithotripsy was performed by electrohydraulic lithotripsy or laser lithotripsy. The primary outcome was complete ductal clearance, defined as the retrieval of all bile duct stones after lithotripsy confirmed by balloon-occluded cholangiography and/or direct POC. Results: The technical success rate of direct POC was 100% (20/20), and the free-hand insertion rate was 95% (19/20). Direct POC-guided lithotripsy, attempted by electrohydraulic lithotripsy in nine patients (45%) and laser lithotripsy in 11 patients (55%), was successful in 95% (19/20) of the patients. Complete ductal clearance after direct POC-guided lithotripsy was achieved in 95% (19/20) of patients. Patients required a median of 2 (range, 1-3) endoscopic retrograde cholangiopancreatography sessions for complete stone removal. Adverse event was observed in one patient (5%) with hemobilia and was treated conservatively. Conclusions: Direct POC using an MB ultraslim endoscope was safe and effective for lithotripsy in patients with difficult bile duct stones.

Safety and efficacy of a novel electrocautery-enhanced lumen-apposing metal stent in interventional EUS procedures (with video).

BACKGROUND AND AIMS: Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures. METHODS: We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021. RESULTS: Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS. CONCLUSIONS: Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications.

Modified non-flared fully covered self-expandable metal stent for preoperative biliary drainage in pancreatic cancer.

BACKGROUND AND AIM: Durable biliary drainage is essential in patients with pancreatic cancer in the era of effective neoadjuvant chemotherapy (NACT). Plastic stent (PS) tends to occlude easily, and current metal stents are designed for nonresectable cancer. We evaluated the efficacy of a modified non-flared fully covered self-expandable metal stent (M-FCSEMS) during the perioperative period in patients with resectable or borderline resectable pancreatic cancer. METHODS: Consecutive patients with resectable or borderline resectable pancreatic ductal adenocarcinoma had a 12-mm M-FCSEMS (M-FCSEMS group) or 7-Fr PS (PS group) placed for biliary decompression before NACT or curative-intent surgery. The primary outcome was the re-intervention rate, and secondary outcomes were technical success, stent patency, and adverse events (AEs). RESULTS: Endoscopic stent placement was technically successful in all 60 patients. Twenty-three patients underwent surgery and 37 NACT before surgery. Re-intervention was performed in 10.0% (3/30) of patients in the M-FCSEMS group and 36.7% (11/30) of patients in the PS group (P = 0.030). The stent patency at 180 days was 89.8% (95% confidence interval, 77.3-100.0%) in the M-FCSEMS group and 30.2% (95% confidence interval, 11.4-80.0%) in the PS group (P < 0.0001). Stent-related AEs occurred in 10.0% (3/30) in the M-FCSEMS group and 40.0% (12/30) in the PS group (P = 0.015). Surgery-related AEs occurred in 10.5% (2/19) and 14.3% (3/21) in the M-FCSEMS and PS groups (P = 0.549). CONCLUSIONS: Modified non-flared fully covered self-expandable metal stents are effective and safe for durable biliary drainage in patients with resectable or borderline resectable pancreatic cancer during the perioperative period.

Use of peroral cholangioscopy to screen for neoplastic bile duct lesions in patients with bile duct stones (with videos).

BACKGROUND AND AIMS: Although cholangiocarcinomas (CCAs) can be diagnosed using several modalities, the detection of early-stage cancers remains unsatisfactory. We explored whether peroral cholangioscopy (POC) could be used to screen for neoplastic bile duct lesions including CCAs in patients with bile duct stones. METHODS: Two hundred seven patients who underwent endoscopic removal of bile duct stones were enrolled between August 2010 and July 2018. The primary outcome was the detection rate of intraductal neoplastic biliary lesions by direct POC. Secondary outcomes were the technical success rates of direct POC and POC-guided forceps biopsy sampling (POC-FB), the diagnostic accuracy of the direct POC findings, adverse events, and the number needed to screen to detect a neoplastic bile duct lesion. RESULTS: Direct POC was successful in 199 of 207 patients (96.1%). Mild cholangitis developed in 2 patients (1.0%) and was treated conservatively. Of the 199 successfully performed POCs, 31 patients (15.6%) exhibited abnormal intraductal mucosal lesions. The technical success rate of POC-FB was 90.3% (28/31 patients). The pathologic diagnoses after POC-FB were CCAs (n = 4), intraductal papillary neoplasms of the bile duct (IPN-B) (n = 2), an adenoma with dysplasia (n = 1), and benign lesions (n = 21). Direct POC correctly distinguished non-neoplastic from neoplastic bile duct lesions in 91.6% of patients. Curative surgical resection was performed for the 5 patients with CCAs or IPN-B. The number needed to screen to detect a neoplastic bile duct lesion was 29.6. CONCLUSIONS: Direct POC using a dedicated, ultraslim upper endoscope usefully screens for neoplastic bile duct lesions including CCAs in selected patients with bile duct stones.

Perirenal hematoma in a patient treated with bevacizumab for metastatic colon cancer: A case report.

The present study reports the case of a patient that developed spontaneous perirenal hematoma during treatment with bevacizumab-containing chemotherapy. A 44-year-old woman with metastatic sigmoid colon cancer, who was being treated with bevacizumab (5 mg/kg, intravenous, 90 min biweekly), was admitted to hospital following 3 cycles of chemotherapy, with a sudden onset of dyspnea and oliguria. An emergency hemodialysis was performed and a large right perirenal hematoma was diagnosed using computed tomography. The patient was immediately instructed to discontinue chemotherapy, including bevacizumab. However, the right perirenal hematoma increased in size and a left perirenal hematoma developed 3 weeks later. The two perirenal hematomas stabilized 7 weeks subsequent to the termination of bevacizumab treatment. Spontaneous perirenal hematoma due to bevacizumab treatment is an extremely rare occurrence. However, physicians should be aware of this potential complication associated with bevacizumab treatment.