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.

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.

Gemcitabine and Erlotinib with or without Oxaliplatin in Previously Untreated Advanced Pancreatic Cancer: A Randomized Phase II Trial

Purpose@#Erlotinib has been the only targeted agent to show significantly improved outcomes in pancreatic adenocarcinoma when combined with gemcitabine. We aimed to evaluate whether the addition of oxaliplatin to a combination gemcitabine/erlotinib treatment conferred a clinical benefit in patients with locally advanced unresectable or metastatic pancreatic cancer. @*Materials and Methods@#Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T [gemcitabine 1000 mg/m2 and oxaliplatin 50 mg/m2 on day 1 (D1) and D8 plus erlotinib 100 mg daily for 3 weeks] or GT (gemcitabine 1000 mg/m2 on D1 and D8 plus erlotinib 100 mg daily for 3 weeks). The primary endpoint was the overall response rate (ORR). @*Results@#Between 2013 and 2016, 65 patients were assigned to a treatment group (33 in the GEMOX-T arm, 32 in the GT arm). The ORR was 18.2% [95% confidence interval (CI), 8.82–27.58] in the GEMOX-T arm and 6.2% (95% CI, 0.34–12.06) in the GT arm (p=0.051). The disease control rate was significantly superior in the GEMOX-T arm compared to the GT arm (72.7% vs. 43.8%, p=0.019). After a median follow-up of 19.7 months, the median progression-free survival (PFS) was 3.9 months for the GEMOX-T arm and 1.4 months for the GT arm (p=0.033). However, this did not translate to an improvement in overall survival. The most common grade 3 or higher hematologic adverse events were neutropenia (16.9%) and anemia (13.8%). @*Conclusion@#The addition of oxaliplatin to a first-line gemcitabine/erlotinib regimen demonstrated higher response rates and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.

A Recent Update on Endoscopic Drainage of Advanced Malignant Hilar Obstruction / 대한소화기학회지

Malignant hilar obstruction (MHO) is considered an aggressive perihilar obstruction caused by cholangiocarcinoma, gallbladder cancer, or metastatic malignancies and has a poor prognosis. Although surgical resection is the only curative treatment method, the majority of patients with MHO do not undergo surgery due to an advanced inoperable state at presentation. Currently, effective biliary drainage provides the necessary palliation for symptomatic improvement. Among the drainage methods, percutaneous access may be preferred, especially for advanced MHO because of the technical difficulty involved with other techniques. Recently, primary endoscopic palliation using plastic or metal stents has been shown to have higher technical feasibility and clinical success without increasing adverse events even in patients with high-degree MHO. The development of various accessories, endoscopic ultrasonography, and advances in techniques have facilitated primary endoscopic intervention. However, some aspects continue to be debated such as the palliation methods, appropriate stents, the number of stents, the deployment methods, and additional local ablation therapies.Therefore, this review discusses the current optimal endoscopic treatment methods for advanced MHO based on reported literature.

Gemcitabine and Erlotinib with or without Oxaliplatin in Previously Untreated Advanced Pancreatic Cancer: A Randomized Phase II Trial

Purpose@#Erlotinib has been the only targeted agent to show significantly improved outcomes in pancreatic adenocarcinoma when combined with gemcitabine. We aimed to evaluate whether the addition of oxaliplatin to a combination gemcitabine/erlotinib treatment conferred a clinical benefit in patients with locally advanced unresectable or metastatic pancreatic cancer. @*Materials and Methods@#Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T [gemcitabine 1000 mg/m2 and oxaliplatin 50 mg/m2 on day 1 (D1) and D8 plus erlotinib 100 mg daily for 3 weeks] or GT (gemcitabine 1000 mg/m2 on D1 and D8 plus erlotinib 100 mg daily for 3 weeks). The primary endpoint was the overall response rate (ORR). @*Results@#Between 2013 and 2016, 65 patients were assigned to a treatment group (33 in the GEMOX-T arm, 32 in the GT arm). The ORR was 18.2% [95% confidence interval (CI), 8.82–27.58] in the GEMOX-T arm and 6.2% (95% CI, 0.34–12.06) in the GT arm (p=0.051). The disease control rate was significantly superior in the GEMOX-T arm compared to the GT arm (72.7% vs. 43.8%, p=0.019). After a median follow-up of 19.7 months, the median progression-free survival (PFS) was 3.9 months for the GEMOX-T arm and 1.4 months for the GT arm (p=0.033). However, this did not translate to an improvement in overall survival. The most common grade 3 or higher hematologic adverse events were neutropenia (16.9%) and anemia (13.8%). @*Conclusion@#The addition of oxaliplatin to a first-line gemcitabine/erlotinib regimen demonstrated higher response rates and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.

A Recent Update on Endoscopic Drainage of Advanced Malignant Hilar Obstruction / 대한소화기학회지

Malignant hilar obstruction (MHO) is considered an aggressive perihilar obstruction caused by cholangiocarcinoma, gallbladder cancer, or metastatic malignancies and has a poor prognosis. Although surgical resection is the only curative treatment method, the majority of patients with MHO do not undergo surgery due to an advanced inoperable state at presentation. Currently, effective biliary drainage provides the necessary palliation for symptomatic improvement. Among the drainage methods, percutaneous access may be preferred, especially for advanced MHO because of the technical difficulty involved with other techniques. Recently, primary endoscopic palliation using plastic or metal stents has been shown to have higher technical feasibility and clinical success without increasing adverse events even in patients with high-degree MHO. The development of various accessories, endoscopic ultrasonography, and advances in techniques have facilitated primary endoscopic intervention. However, some aspects continue to be debated such as the palliation methods, appropriate stents, the number of stents, the deployment methods, and additional local ablation therapies.Therefore, this review discusses the current optimal endoscopic treatment methods for advanced MHO based on reported literature.

Predictors of Malignancy in “Pure” Branch-Duct Intraductal Papillary Mucinous Neoplasm of the Pancreas without Enhancing Mural Nodules on CT Imaging: A Nationwide Multicenter Study

BACKGROUND/AIMS: Presence of enhanced mural nodules, which can be visualized using computed tomography (CT), is one of high-risk stigmata in branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs). Conversely, the absence of enhanced mural nodules on preoperative imaging does not exclude malignant risk. The present study aimed to investigate other morphological features as predictors of malignancy in “pure” BD-IPMNs without enhanced mural nodules on CT. METHODS: This retrospective study included 180 patients with surgically confirmed “pure” BD-IPMNs of the pancreas and no enhanced mural nodules on preoperative CT. The study was conducted at 15 tertiary referral centers throughout South Korea. Univariate and multivariate analyses were used to identify significant predictors of malignancy. RESULTS: BD-IPMNs with low-grade (n=84) or moderate-grade (n=76) dysplasia were classified as benign; those with high-grade dysplasia (n=8) or invasive carcinoma (n=12) were classified as malignant. The multivariate analysis revealed that cyst size ≥30 mm (odds ratio, 8.6; p=0.001) and main pancreatic duct diameter ≥5 mm (odds ratio, 4.1; p=0.01) were independent risk factors for malignancy in “pure” BD-IPMNs without enhanced mural nodules on CT. Endoscopic ultrasound detected enhanced mural nodules (6/82) that had been missed on CT, and two IPMNs with enhanced mural nodules were malignant. CONCLUSIONS: In patients with “pure” BD-IPMNs who have no enhanced mural nodules on CT, cyst size ≥30 mm and main pancreatic duct diameter ≥5 mm may be associated with malignancy.

Total and ionized serum magnesium and calcium levels during magnesium sulfate administration for preterm labor

OBJECTIVE: This study aimed to estimate the association between total and ionized magnesium, and the changes in serum magnesium and calcium levels in patients with preterm labor during magnesium sulfate (MgSO4) administration. METHODS: The study population included 64 women who were candidates for intravenous MgSO4 treatment for preterm labor. Serial blood samples were taken and measured total magnesium (T-Mg), ionized magnesium (I-Mg), total calcium (T-Ca), and ionized calcium (I-Ca) levels every one-week interval (1st, 2nd, 3rd). RESULTS: There was no significant difference in T-Mg and I-Mg levels during MgSO4 administration (P>0.05). There was no significant difference in T-Ca and I-Ca levels during MgSO4 administration (P>0.05). Compared before and after administration of MgSO4, T-Mg and I-Mg levels and T-Ca levels were changed allow statistically significant (P 0.05). There was significant correlation between levels of I-Mg and T-Mg (I-Mg=0.395×T-Mg+0.144, P < 0.01). CONCLUSION: There were no significant differences in serum Mg and Ca levels during MgSO4 administration for preterm labor. Compared to the before and after administration of MgSO4, only I-Ca levels were not substantially changed. There are significant correlations between I-Mg and T-Mg levels during administration of MgSO4 and I-Mg level seemed to have more correlation with adverse effect than T-Mg.

Role of Image-Enhanced Endoscopy in Pancreatobiliary Diseases

Recent advances in cholangiopancreatoscopy technology permit image-enhanced endoscopy (IEE) for pancreatobiliary diseases. There are limitations in endoscopy performance and in the study of the clinical role of IEE in bile duct or pancreatic duct diseases. However, currently available IEEs during cholangiopancreatoscopy including traditional dye-aided chromoendoscopy, autofluorescence imaging, narrow-band imaging, and i-Scan have been evaluated and reported previously. Although the clinical role of IEE in pancreatobiliary diseases should be verified in future studies, IEE is a useful promising tool in the evaluation of bile duct or pancreatic duct mucosal lesions.

Prospective Comparison of Intraductal Ultrasonography-Guided Transpapillary Biopsy and Conventional Biopsy on Fluoroscopy in Suspected Malignant Biliary Strictures

BACKGROUND/AIMS: In suspected malignant biliary strictures (MBSs), the diagnostic yield of endoscopic retrograde cholangiopancreatography (ERCP)-based tissue sampling is limited. Transpapillary forceps biopsy (TPB) under intraductal ultrasonography (IDUS) guidance is expected to improve the diagnostic accuracy in patients with indeterminate biliary strictures. We evaluated the usefulness of IDUS-guided TPB in patients with suspected MBS. METHODS: Consecutive patients with suspected MBS were prospectively enrolled in the study. ERCP with IDUS was performed in all patients. Both conventional TPB and IDUS-guided TPB on fluoroscopy were performed in each patient. The primary outcome was the diagnostic accuracy of conventional TPB and IDUS-guided TPB. RESULTS: The technical success rate of IDUS-guided TPB was 97.0% (65/67 patients). Of these 65 patients, the final diagnosis was malignancy in 61 patients (93.8%). On IDUS, the most common finding of IDUS was an intraductal infiltrating lesion in 29 patients (47.5%). The overall diagnostic accuracy was significantly higher using IDUS-guided TPB than that using conventional TPB (90.8% vs 76.9%, p=0.027). According to the subgroup analysis based on the tumor morphology, IDUS-guided TPB had a significantly higher cancer detection rate than conventional TPB for intraductal infiltrating lesions (89.6% vs 65.5%, p=0.028). CONCLUSIONS: IDUS-guided TPB appears to improve the accuracy of histological diagnosis in patients with MBS.

Is the Isolated-Tip Needle-Knife Precut as Effective as Conventional Precut Fistulotomy in Difficult Biliary Cannulation?

BACKGROUND/AIMS: Needle-knife precut fistulotomy (NK-F) is a well-known freehand technique for difficult biliary cannulation (DBC). Another approach involves the use of Iso-Tome®, a modified precutting device with an insulated needle tip to prevent direct thermal injury. This comparative study aimed to evaluate the efficacy of the Iso-Tome® precut (IT-P) compared to that of NK-F for DBC. METHODS: Patients with a naive papilla who underwent early IT-P or NK-F for DBC were enrolled. DBC was defined as failure to achieve selective biliary access by wire-guided cannulation despite 5 minutes of attempted cannulation, ≥5 papillary contacts, or a hook-nose-shaped papilla. The primary endpoint was the primary technical success rate, which was based on a noninferiority model. RESULTS: A total of 239 DBC cases were enrolled. The primary technical success rates were 74.7% (89/119) in the IT-P group and 91.6% (110/120) in the NK-F group (lower limit of 90% confidence interval, −0.23; p=0.927 for a noninferiority margin of 10%). The total technical success rates were 87.4% and 95.0%, respectively (p=0.038). The mean precutting times for successful biliary access were 11.2 minutes for IT-P and 7.3 minutes for NK-F (p < 0.01). The procedure-related adverse event rates were 9.2% for IT-P and 5.8% for NK-F (p=0.318). The rates of post-endoscopic retrograde cholangiopancreatography pancreatitis were 4.2% and 2.5%, respectively (p=0.499). CONCLUSIONS: IT-P failed to exhibit noninferiority compared with NK-F regarding the primary technical success rate of DBC, but there was no difference in the frequency of adverse events.

Recent Advances of Peroral Cholangioscopy / 대한내과학회지

No abstract available.

Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction

BACKGROUND/AIMS: Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. METHODS: A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. RESULTS: The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). CONCLUSIONS: Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs.

The Role of Endoscopic Biliary Drainage without Sphincterotomy in Gallstone Patients with Cholangitis and Suspected Common Bile Duct Stones Not Detected by Cholangiogram or Intraductal Ultrasonography

BACKGROUND/AIMS: Treatment for cholangitis without common bile duct (CBD) stones has not been established in patients with gallstones. We investigated the usefulness of endoscopic biliary drainage (EBD) without endoscopic sphincterotomy (EST) in patients diagnosed with gallstones and cholangitis without CBD stones by endoscopic retrograde cholangiopancreatography (ERCP) and intraductal ultrasonography (IDUS). METHODS: EBD using 5F plastic stents without EST was performed prospectively in patients with gallstones and cholangitis if CBD stones were not diagnosed by ERCP and IDUS. After ERCP, all patients underwent laparoscopic cholecystectomy. The primary outcomes were clinical and technical success. The secondary outcomes were recurrence rate of biliary events and procedure-related adverse events. RESULTS: Among 187 patients with gallstones and cholangitis, 27 patients without CBD stones according to ERCP and IDUS received EBD using 5F plastic stents without EST. The stents were maintained in all patients until laparoscopic cholecystectomy, and recurrence of cholangitis was not observed. After cholecystectomy, the stents were removed spontaneously in 12 patients and endoscopically in 15 patients. Recurrence of CBD stones was not detected during the follow-up period (median, 421 days). CONCLUSIONS: EBD using 5F plastic stents without EST may be safe and effective for the management of cholangitis accompanied by gallstones in patients without CBD stones according to ERCP and IDUS.

A Double-Layered Covered Biliary Metal Stent for the Management of Unresectable Malignant Biliary Obstruction: A Multicenter Feasibility Study

BACKGROUND/AIMS: The covered self-expandable metal stent (CMS) was developed to prevent tumor ingrowth-induced stent occlusion during the treatment of malignant biliary obstruction. However, complications such as cholecystitis, pancreatitis, and stent migration can occur after the endoscopic insertion of CMSs. The aim of the present study was to assess the efficacy and safety of a double-layered CMS (DCMS) for the management of malignant bile duct obstruction. METHODS: DCMSs were endoscopically introduced into 59 patients with unresectable malignant extrahepatic biliary obstruction at four tertiary referral centers, and the patient medical records were retrospectively reviewed. RESULTS: Both the technical and functional success rates were 100%. Procedure-related complications including pancreatitis, cholangitis, stent migration, and liver abscess occurred in five patients (8.5%). The median follow-up period was 265 days (range, 31 to 752 days). Cumulative stent patency rates were 68.2% and 40.8% at 6 and 12 months, respectively. At the final follow-up, the rate of stent occlusion was 33.9% (20/59), and the median stent patency period was 276 days (range, 2 to 706 days). CONCLUSIONS: The clinical outcomes of DCMSs were comparable to the outcomes previously reported for CMSs with respect to stent patency period and complication rates.

Endoscopic Extraction of Biliary Fascioliasis Diagnosed Using Intraductal Ultrasonography in a Patient with Acute Cholangitis

Fasciola hepatica infection may result in biliary obstruction with or without cholangitis in the chronic biliary phase. Because clinical symptoms and signs of F. hepatica are similar to other biliary diseases that cause bile duct obstruction, such as stones or bile duct malignancies, that are, in fact, more common, this condition may not be suspected and diagnosis may be overlooked and delayed. Patients undergoing endoscopic retrograde cholangiopancreatography or endoscopic ultrasonography for the evaluation of bile duct obstruction may be incidentally detected with the worm, and diagnosis can be confirmed by extraction of the leaf-like trematode from the bile duct. Intraductal ultrasonography (IDUS) can provide high-resolution cross-sectional images of the bile duct, and is useful in evaluating indeterminate biliary diseases. We present a case of biliary fascioliasis that was diagnosed using IDUS and managed endoscopically in a patient with acute cholangitis.

Synchronous Pancreatic Ductal Adenocarcinomas Diagnosed by Endoscopic Ultrasound-Guided Fine Needle Biopsy

Cases of pancreatic ductal adenocarcinoma with multiple masses accompanying underlying pancreatic diseases, such as intraductal papillary mucinous neoplasm, have been reported. However, synchronous invasion without underlying pancreatic disease is very rare. A 61-year-old female with abdominal discomfort and jaundice was admitted to our hospital. Abdominal computed tomography (CT) revealed cancer of the pancreatic head with direct invasion of the duodenal loop and common bile duct. However, positron emission tomography-CT showed an increased standardized uptake value (SUV) in the pancreatic head and tail. We performed endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for the histopathologic diagnosis of the pancreatic head and the evaluation of the increased SUV in the tail portion of the pancreas, as the characteristics of these lesions could affect the extent of surgery. As a result, pancreatic ductal adenocarcinomas were confirmed by both cytologic and histologic analyses. In addition, immunohistochemical analysis of the biopsy specimens was positive for carcinoembryonic antigen and p53 in both masses. The two masses were ultimately diagnosed as pancreatic ductal adenocarcinoma, stage IIB, based on EUS-FNB and imaging studies. In conclusion, the entire pancreas must be evaluated in a patient with a pancreatic mass to detect the rare but possible presence of synchronous pancreatic ductal adenocarcinoma. Additionally, EUS-FNB can provide pathologic confirmation in a single procedure.

New Technique of Endoscopic Sphincterotomy with Iso-Tome(R) to Incise the Distal Papillary Roof in Patients with Choledocholiths and Choledochoduodenal Fistula

BACKGROUND/AIMS: It is sometimes difficult to incise the distal papillary roof (PR) completely in patients with choledocholiths and choledochoduodenal fistula (CDF). The Iso-Tome(R) (MTW-Endoskopie W. Haag KG), which is helpful in preventing electrical leakage, has good orientation capabilities and can be easily placed at the orifice of the CDF or ampulla of Vater (AV). We aimed to evaluate the efficacy of endoscopic sphincterotomy (ES) with the Iso-Tome(R) for cutting the distal PR. METHODS: Between May 2003 and July 2012, 35 patients were analyzed retrospectively. The distal PR was cut downward and/or upward using the Iso-tome(R) until the pink intrapapillary mucosa was fully exposed. Downward incisions were performed from the opening of the CDF to the orifice of the AV; upward incisions were performed in reverse. RESULTS: Spontaneous or artificial CDF occurred in four and 31 patients, respectively. The technical and therapeutic success rates were 94.3% (33/35) and 94.3% (33/35), respectively. There was no case of electrical damage to the pink intrapapillary mucosa. Adverse events occurred in 2.9% (1/35; 1, mild bleeding) of patients. CONCLUSIONS: The new technique of ES with the Iso-tome(R) is feasible and useful for effectively incising the distal PR in patients with CDF and choledocholiths.

New Technique of Endoscopic Sphincterotomy with Iso-Tome(R) to Incise the Distal Papillary Roof in Patients with Choledocholiths and Choledochoduodenal Fistula

BACKGROUND/AIMS: It is sometimes difficult to incise the distal papillary roof (PR) completely in patients with choledocholiths and choledochoduodenal fistula (CDF). The Iso-Tome(R) (MTW-Endoskopie W. Haag KG), which is helpful in preventing electrical leakage, has good orientation capabilities and can be easily placed at the orifice of the CDF or ampulla of Vater (AV). We aimed to evaluate the efficacy of endoscopic sphincterotomy (ES) with the Iso-Tome(R) for cutting the distal PR. METHODS: Between May 2003 and July 2012, 35 patients were analyzed retrospectively. The distal PR was cut downward and/or upward using the Iso-tome(R) until the pink intrapapillary mucosa was fully exposed. Downward incisions were performed from the opening of the CDF to the orifice of the AV; upward incisions were performed in reverse. RESULTS: Spontaneous or artificial CDF occurred in four and 31 patients, respectively. The technical and therapeutic success rates were 94.3% (33/35) and 94.3% (33/35), respectively. There was no case of electrical damage to the pink intrapapillary mucosa. Adverse events occurred in 2.9% (1/35; 1, mild bleeding) of patients. CONCLUSIONS: The new technique of ES with the Iso-tome(R) is feasible and useful for effectively incising the distal PR in patients with CDF and choledocholiths.

Second-Line Chemotherapy in Advanced Biliary Tract Cancer: A Retrospective Analysis

OBJECTIVE: The evidence of 2nd line chemotherapy has not been validated. We investigated the treatment outcomes of 2nd line palliative chemotherapy in patients with biliary tract cancer (BTC) and analyzed the factors affecting response or survival. METHODS: We retrospectively reviewed and analyzed the outcomes in advanced BTC patients who underwent 2nd line chemotherapy in Soonchunhyang Universitiy Hospitals (Bucheon, Seoul, and Cheonan). RESULTS: From December 2004 to May 2014, 65 patients were enrolled. The median age was 56 years (range, 40 to 76 years) and the ratio of cholangiocarcinoma (intrahepatic or extrahepatic), gall bladder cancer, and ampulla of Vater cancer was 41 (63.1%):18 (27.7%):6 (9.25%). Half of the patients (33 patients, 50.8%) were treated with gemcitabine-based and 28 patients (43.1%) with 5-fluorouracil- based therapy. The response rate was 3.0% and disease control rate was 21.5% in intention-to-treat analysis. Median overall survival (OS) was 7.2 months (95% confidence interval [CI], 3.9 to 10.5 months) and median progression free survival (PFS) was 3.7 months (95% CI, 2.5 to 4.9 months). In multivariate analysis, patients with good performance status (PS) (P=0.001) and chemo-sensitive tumor to 2nd line chemotherapy (P=0.000) had longer PFS as compared to the others. In addition, patients with good PS (P=0.003), chemo-sensitive tumor to 1st line (P=0.046), and 2nd line chemotherapy (P=0.004) were good prognostic factors for OS. CONCLUSION: The effect of 2nd line chemotherapy in advanced BTC was modest and maybe beneficial in select patients.