Efficacy Analysis of Suprapapillary versus Transpapillary Self-Expandable Metal Stents According to the Level of Obstruction in Malignant Extrahepatic Biliary Obstruction

Background/Aims@#The use of a self-expandable metal stent (SEMS) is recommended for unresectable malignant biliary obstruction (MBO). Stent-related adverse events might differ according to the position of the stent through the ampulla of Vater (AOV). We retrospectively evaluated SEMS patency and adverse events according to the position of the SEMS. @*Methods@#In total, 280 patients who underwent endoscopic SEMS placement due to malignant distal biliary obstruction were analyzed retrospectively. Suprapapillary and transpapillary SEMS insertions were performed on 51 patients and 229 patients, respectively. @*Results@#Between the suprapapillary group (SPG) and transpapillary group (TPG), the stent patency period was not significantly different (median [95% confidence interval]: 107 days [82.3 to 131.7] vs 120 days [99.3 to 140.7], p=0.559). There was also no significant difference in the rate of adverse events. In subgroup analysis, the stent patency for an MBO located within 2 cm from the AOV was found to be significantly shorter than that for an MBO located more than 2 cm from the AOV in the SPG (64 days [0 to 160.4] vs 127 days [82.0 to 171.9], p<0.001) and TPG (87 days [52.5 to 121.5] vs 130 [97.0 to 162.9], p<0.001). Patients with an MBO located within 2 cm from the AOV in both groups had a higher percentage of duodenal invasion (SPG: 40.0% vs 4.9%, p=0.002; TPG: 28.6% vs 2.9%, p<0.001) than patients with an MBO located more than 2 cm from the AOV. @*Conclusions@#The SPG and TPG showed similar results in terms of stent patency and rate of adverse events. However, patients with an MBO located within 2 cm from the AOV had a higher percentage of duodenal invasion with shorter stent patency than those with an MBO located more than 2 cm from the AOV, regardless of stent position.

Comparison of Interleukin-6, C-Reactive Protein, Procalcitonin, and the Computed Tomography Severity Index for Early Prediction of Severity of Acute Pancreatitis

Background/Aims@#Acute pancreatitis (AP) is a common gastrointestinal disease associated with hospitalization. With the increase in its incidence, AP has become a greater burden on healthcare resources. Early identification of patients with mild AP can facilitate the appropriate use of resources. We aimed to investigate the ability of inflammatory markers, including interleukin-6 (IL-6), procalcitonin, and C-reactive protein (CRP), as well as various scoring systems to differentiate mild AP from more severe diseases. @*Methods@#We retrospectively investigated patients hospitalized with AP, for whom severity assessment and clinical course confirmation were possible. Inflammatory markers were measured at admission, and CRP levels were measured 24 hours after admission (CRP2). Predictive values were calculated using the area under the receiver operating characteristic curve (AUROC) and logistic regression model analysis. @*Results@#Of 103 patients with AP, 42 (40.8%) were diagnosed with mild AP according to the revised Atlanta classification. Based on the AUROC, IL-6 (0.755, p<0.001), CRP2 (0.787, p<0.001), and computed tomography severity index (CTSI) (0.851, p<0.001) were useful predictors of mild AP. With standard cutoff values, the diagnostic sensitivity, specificity, and accuracy were 83.3%, 62.3%, and 70.9% for IL-6 (<50 pg/mL), and 78.6%, 63.9%, and 69.9% for CRP2 (<50 mg/L), respectively. The AUROC of IL-6 and CRP2 were significantly higher than those of other inflammatory markers and were not significantly different from that of CTSI. @*Conclusions@#IL-6, CRP2, and CTSI are helpful for early differentiation of AP severity. Among inflammatory markers, IL-6 has the advantage of early prediction of mild pancreatitis at the time of admission.

Comparison of Clinical Performance and Safety between Domestic New Pull-type Triple-lumen Sphincterotome and Conventional Sphincterotome: A Prospective Multicenter Trial / 대한소화기학회지

Background/Aims@#Sphincterotomes are essential for endoscopic sphincterotomy (EST) and can also be used for cannulation in ERCP.A domestic new pull-type sphincterotome (Optimos™, Taewoong, Goyang, Korea) provides acceptable technical feasibility and safety, but there are no comparison results. Thus, this study compared the clinical performance and safety of Optimos™ sphincterotome to a conventional sphincterotome (CleverCut3™, Olympus, Tokyo, Japan) in patients who underwent ERCP. @*Methods@#From April 2021 to July 2021, a randomized prospective comparative study was conducted on 104 consecutive patients who underwent ERCP in three medical centers. The primary endpoint was the clinical performance and safety of sphincterotomes during ERCP. @*Results@#One hundred and four patients were assigned randomly to the Optimos™ group (n=51) or CleverCut3™ group (n=53). All demographic characteristics did not differ between the groups except the BMI. The technical success rate for cannulation, performance of EST, and total procedure time were similar in the two groups. The adverse events did not differ, even though two cases of post-ERCP pancreatitis occurred in CleverCut3™. On the other hand, in questionnaire analysis, CleverCut™ showed a better user’s convenience (median [interquartile range] 4.0 [3.0-4.0] vs. 3.0 [3.0-4.0], p=0.013) and manipulability (median [interquartile range], 4.0 [3.0-4.0] vs. 3.0 [3.0-4.0], p=0.039) than Optimos™, even though the other profiles did not reveal any differences. @*Conclusions@#New domestic pull-type sphincterotome can offer comparable clinical performance and safety profiles to conventional sphincterotome, but it needs refinements to increase the user’s convenience and manipulability. Further improvement and innovation will be required to advance domestic medical devices.

Effect of fast track on prognosis in patients with common bile duct obstruction with cholangitis in emergency department

Objective@#Biliary decompression through bile drainage is a key treatment for common bile duct obstruction with cholangitis. However, the effectiveness of early interventions has not been studied sufficiently in Korea. This study investigated the effectiveness of fast-track biliary decompression. @*Methods@#A group of patients diagnosed with common bile duct obstruction with cholangitis between January 1, 2014, and December 31, 2019, was reviewed retrospectively. We divided them into two groups: before and after the implementation of fast-track biliary decompression. The following items were analyzed in the two groups: time to intervention, number of hospital days, length of stay in the emergency department, and intensive care unit (ICU) admission. @*Results@#Between January 1, 2014, and December 31, 2019, 418 patients were admitted for common bile duct obstruction, and a total of 369 patients were included in this study. Of these, 168 patients visited the hospital prior to implementation of the treatment, and 201 patients visited after implementation. The time to intervention was 6.1 (4.2-11.0) hours in the fast-track group, which was about 9 hours shorter than the other group (P<0.001). There was no statistical difference in the number of hospital days, emergency department length of stay, and ICU admissions (P=0.535, P=0.034, P=0.322). @*Conclusion@#The time to intervention was shortened significantly in the fast-track group. However, we did not observe a significant improvement in patient prognosis. It may be possible that the procedure time may need to be shortened for a better prognosis. This should be investigated in future studies.

Recent Updates on Endoscopic Retrograde Cholangiography-guided Intraductal Radiofrequency Ablation for Malignant Biliary Stricture / 대한소화기학회지

Malignant biliary strictures are caused by pancreatobiliary cancer and other metastatic malignancies. Most of them are unresectable at diagnosis with a dismal prognosis. Various new ablation methods have been introduced. Of them, ERCP-guided intraductal radiofrequency ablation (ID-RFA) appears to be the most promising minimally invasive endoscopic treatment by delivering a high-frequency alternating current to the target tissue, leading to coagulative necrosis. Thus far, many studies have provided evidence that ERCP-guided ID-RFA is a safe, feasible, and effective treatment modality for stent patency and overall survival. Compared to other ablation treatments, ERCP-guided ID-RFA has several advantages, including ease of delivery, controlled application of thermal energy, low cost, and fewer systemic side effects with an acceptable safety profile. Therefore, ERCP-guided ID-RFA can be considered an adjunctive treatment for the palliation of unresectable malignant biliary strictures. On the other hand, the decision of local ablation treatment should be individualized by multidisciplinary team support due to the lack of comparative studies.

Management of Small Pancreatic Neuroendocrine Neoplasm / 대한소화기암학회지

The incidence of small and asymptomatic pancreatic neuroendocrine neoplasms (PNENs) has been increased due to the widespread use of high-resolution imaging techniques and endoscopic procedures in screening programmes. Most of PNENs are indolent neoplasms with slow-growing. However, sometimes, PNENs show local invasion or metastasis with poor prognosis. The management of small, nonfunctioning PNENs remain under debate. The National Comprehensive Cancer Network guidelines recommend observation in selected cases of small PNENs less than 2 cm. Pancreatic surgeons are divided into two factions: “the hawks,” who indicate the high risk of malignancy even in small PNENs and, therefore, the need for an aggressive surgical treatment, and the “the doves,” who accepts the risk of malignancy in some ≤ 2 cm PNENs, advocate that the risk of overtreating many benign ≤ 2 cm PNENs would be much higher. As the pancreatic surgery remains a high-risk operation with a 28–30% morbidity and 1% mortality, the decision for small PNENs is challenging.

Management of Small Pancreatic Neuroendocrine Neoplasm / 대한소화기암학회지

The incidence of small and asymptomatic pancreatic neuroendocrine neoplasms (PNENs) has been increased due to the widespread use of high-resolution imaging techniques and endoscopic procedures in screening programmes. Most of PNENs are indolent neoplasms with slow-growing. However, sometimes, PNENs show local invasion or metastasis with poor prognosis. The management of small, nonfunctioning PNENs remain under debate. The National Comprehensive Cancer Network guidelines recommend observation in selected cases of small PNENs less than 2 cm. Pancreatic surgeons are divided into two factions: “the hawks,” who indicate the high risk of malignancy even in small PNENs and, therefore, the need for an aggressive surgical treatment, and the “the doves,” who accepts the risk of malignancy in some ≤ 2 cm PNENs, advocate that the risk of overtreating many benign ≤ 2 cm PNENs would be much higher. As the pancreatic surgery remains a high-risk operation with a 28–30% morbidity and 1% mortality, the decision for small PNENs is challenging.

A Hybrid Online and Offline International Conference of the Korean Pancreatobiliary Association in Post-COVID-19 Era / 대한췌담도학회지

Background@#/Aim: The COVID-19 pandemic has changed the way of traditional conference and meeting. Since social distancing rule was important issue, many conferences across the world were cancelled or postponed indefinitely. In 2020, International Conference of the Korean Pancreatobiliary Association (IC-KPBA) was held as a hybrid online and offline conference. Here, we report the result of a national survey about online and offline medical conference in Korea. @*Methods@#The survey was performed for both online and offline participants after IC-KPBA. The contents of survey included their way to access the hybrid online-offline conference and satisfaction with the conference format. @*Results@#Total of 78 participants answered the survey and there was no technical problem. Most offline participants were satisfied the prevention measures at conference hall as follows; very satisfied-56%; satisfied-34%. The quality of video and audio were generally satisfactory in both conference hall and virtual conference. ‘Live online lectures’ is the most preferred method of lecture delivery and personal computer with LAN network is preferred to access online conference. Eighty seven percent of offline participants and 91% of online participants answered satisfied and very satisfied, respectively. @*Conclusions@#Participants of IC-KPBA 2020 with hybrid online-offline conference showed a high level of satisfaction.

Drug-eluting Biliary Stent / 대한췌담도학회지

Biliary drainage is necessary to improve the survival or quality of life of patients with malignant biliary obstruction. In the past, surgery was the primary treatment for biliary drainage, but recently, endoscopic or percutaneous stent implantation has been recognized as the main treatment. Various materials and structures have been devised and developed to increase the patency of the biliary stent. In the development of these stents, drug-eluting biliary stents with an anti-tumoral agent (DES) have emerged to increase the stent patency period by chemically inhibiting tumor growth in the stent through the change of the coating material. The DESs have been proved to be stable through several animal and clinical trials, but their effectiveness has not been demonstrated. We will discuss the development process, problems, and future directions of DES that has been clinically applied.

Recent Updates on Diagnosis, Treatment, and Follow-up of Gallbladder Polyps / 대한소화기학회지

A gallbladder (GB) polyp is an elevation of the GB mucosa that protrudes into the GB lumen. GB polyps have an estimated prevalence of 0.3-9.5% and can be divided into neoplastic (true) polyps and nonneoplastic polyps (pseudopolyps). Pseudopolyps are most commonly cholesterol polyps but also include focal adenomyomatosis and inflammatory polyps with no malignant potential. Neoplastic polyps, however, can be benign or malignant. Benign polyps are most commonly adenomas, while malignant polyps are usually adenocarcinoma. Transabdominal ultrasonography is the main radiological modality used for diagnosing and surveilling GB polyps. On the other hand, because it is difficult to diagnose GB polyps before surgery, alternative imaging modalities, such as endoscopic ultrasound, are being further evaluated. The current guidelines recommend cholecystectomy for GB polyps ≥ 10 mm in size as well as suboptimal sized GB polyps (6-9 mm) with other risk factors, including age >50, sessile, and symptoms. The quality of the evidence behind this practice is relatively low. Therefore, this review identifies the current gaps in the available evidence and guidelines and introduces methods that can help make decisions regarding patients who require a cholecystectomy or follow-up.

Magnetic Compression Anastomosis for the Treatment of Post-Transplant Biliary Stricture

A number of different conditions can lead to a bile duct stricture. These strictures are particularly common after biliary operations, including living-donor liver transplantation. Endoscopic and percutaneous methods have high success rates in treating benign biliary strictures. However, these conventional methods are difficult to manage when a guidewire cannot be passed through areas of severe stenosis or complete obstruction. Magnetic compression anastomosis has emerged as an alternative nonsurgical treatment method to avoid the mortality and morbidity risks of reoperation. The feasibility and safety of magnetic compression anastomosis have been reported in several experimental and clinical studies in patients with biliobiliary and bilioenteric strictures. Magnetic compression anastomosis is a minimally traumatic and highly effective procedure, and represents a new paradigm for benign biliary strictures that are difficult to treat with conventional methods.

What is the better surgical treatment option for recurrent common bile duct stones?

Purpose@#Repeating endoscopic retrograde cholangiopancreatography (ERCP) in patients with recurrent common bile duct (CBD) stones is problematic in many ways. Choledochoduodenostomy (CDS) and choledochojejunostomy (CJS) are 2 surgical treatment options for recurrent CBD stones, and each has different advantages and disadvantages. The aim of this study was to compare the 2 surgical options in terms of the recurrence rate of CBD stones after surgical treatment. @*Methods@#This retrospective multicenter study included all patients who underwent surgical treatment due to recurrent CBD stones that were not effectively controlled by medical treatment and repeated ERCP between January 2006 and March 2015. We collected data from chart reviews and medical records. A recurrent CBD stone was defined as a stone found 6 months after the complete removal of a CBD stone by ERCP. Patients who underwent surgery for other reasons were excluded. @*Results@#A total of 27 patients were enrolled in this study. Six patients underwent CDS, and 21 patients underwent CJS for the rescue treatment of recurrent CBD stones. The median follow-up duration was 290 (180–1,975) days in the CDS group and 1,474 (180–6,560) days in the CJS group (P = 0.065). The postoperative complications were similar and tolerable in both groups (intestinal obstruction; 2 of 27, 7.4%; 1 in each group). CBD stones recurred in 4 patients after CDS (4 of 6, 66.7%), and 3 patients after CJS (3 of 21, 14.3%) (P = 0.010). @*Conclusion@#CJS may be a better surgical option than CDS for preventing further stone recurrence in patients with recurrent CBD stones.

Safety Evaluation of Paclitaxel-Eluting Biliary Metal Stent with Sodium Caprate in Porcine Biliary Tract

BACKGROUND/AIMS: Metallic stents designed to relieve malignant biliary obstruction are susceptible to occlusive tumor ingrowth or overgrowth. In a previous report, we described metallic stents covered with paclitaxel-incorporated membrane (MSCPM-I, II) to prevent occlusion from tumor ingrowth via antitumor effect. This new generation paclitaxel-eluting biliary stent is further endowed with sodium caprate (MSCPM-III) for enhanced drug delivery. The purpose of this study is to examine the safety of its drug delivery system in the porcine biliary tract. METHODS: MSCPM-III (10% [wt/vol] paclitaxel) and covered metal stents (CMSs) were endoscopically inserted in porcine bile ducts in vivo. Histologic biliary changes, levels of paclitaxel released, and various serum analytes (albumin, alkaline phosphate, aspartate transaminase, alanine transaminase, total protein, total bilirubin, and direct bilirubin) were assessed. RESULTS: Based on the intensity of reactive inflammation and fibrosis, changes in porcine biliary epithelium secondary to implanted MSCPM-III were deemed acceptable (i.e., safe). Histologic features in the MSCPM-III and CMS groups did not differ significantly. In a related serum analysis, paclitaxel release from MSCPM-III stents was below the limit of detection for 28 days. Biochemical analyses were also similar for the two groups, and no evidence of hepatic or renal toxicity was found in animals receiving MSCPM-III stents. CONCLUSIONS: In a prototypic porcine trial, this newly devised metal biliary stent incorporating both paclitaxel and sodium caprate appears to be safe in the porcine bile duct.

Endoscopic Sphincterotomy, Balloon Stone Extraction, and Basket Stone Extraction / 대한췌담도학회지

Endoscopic sphincterotomy is performed after selective cannulation to remove the gallstone. Endoscopic sphincterotomy can cause complications such as bleeding, perforation and pancreatitis. Various types of endoscopic sphincter incision method and current generators used for incisions have been developed to reduce the incidence of such complications and increase the success rate of the procedure. In addition, guidelines for the direction and extent of endoscopic sphincterotomy and incision technique are established. The method used for the removal of gallstones after the endoscopic sphincterotomy is a method using a balloon and/or a basket. This review introduces the technical methods of endoscopic sphincterotomy and discusses the clinical indications and technical methods for representative methods of effective gallstone removal.

Anastomotic stricture after liver transplantation: It is not Achilles' heel anymore!

Biliary-tract complications, such as biliary strictures, anastomotic leaks, choledocholithiasis, and biliary casts, can occur after liver transplantation (LT). Of these complications, biliary strictures are regarded as an Achilles' heel. Recently, treatment of anastomotic biliary stricture (ABS) has transitioned from conventional surgical revision to a nonsurgical treatment modality. Endoscopic serial balloon dilatation and/or multiple plastic stent replacements are highly effective and are now regarded as the first-line treatments. However, if the patient has undergone anastomosis by means of a hepaticojejunostomy, percutaneous treatment is performed. With recent technological advances and the rendezvous method, the clinical success rates of endoscopic and percutaneous ABS treatments have increased, but these methods fail in some patients who have total obstruction of anastomotic stricture. For these patients, magnetic compression anastomosis (MCA) has been suggested as an alternative method. Animal and human studies have demonstrated the safety and efficacy of MCA, and advancements in these nonsurgical methods have increased the clinical success rate of ABS. This review focuses on ABSs that develop after LT and discusses the clinical results of various nonsurgical methods and future directions.

Clinical Practice Guideline for Common Bile Duct Stones: Diagnosis and Treatment / 대한소화기학회지

Common bile duct (CBD) stone is a biliary disease with an increasing incidence in Korea. Many advances have been made in diagnosis and treatment according to the development of imaging equipment and various devices to diagnose and treat CBD stones. The Korean Society for Pancreatobiliary Association has developed clinical practice guidelines for the diagnosis and treatment of CBD stones to assist clinicians in their management. The guidelines were divided into three parts: evaluation of CBD stones, endoscopic management of CBD stones, and endoscopic management of difficult and recurrent CBD stones. The purpose of this review is to summarize and present the diagnosis and treatment guidelines for CBD stones established in Korea.

Efficacy of a Multiplex Paclitaxel Emission Stent Using a Pluronic® Mixture Membrane versus a Covered Metal Stent in Malignant Biliary Obstruction: A Prospective Randomized Comparative Study

BACKGROUND/AIMS: A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. METHODS: This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. RESULTS: The two groups did not differ significantly in basic characteristics and mean follow-up period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. CONCLUSIONS: There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

Pancreatic perforation caused by the Soehendra® retrieval device in a patient with chronic pancreatitis

SUMMARY OF EVENT: An endoscopic retrograde pancreatic duct (ERPD) stent was inserted in a male patient with chronic pancreatitis via endoscopic retrograde cholangiopancreatography (ERCP) to relieve chronic epigastric pain. After the procedure, an abdominal computed tomography scan showed localized peritonitis with a dislocated ERPD stent. The patient underwent an emergency operation, which revealed that the peritonitis was caused by perforation of the pancreatic parenchyma by the ERPD stent. TEACHING POINT: A hydrophilic guide wire can puncture the pancreas during ERPD stent insertion. Therefore, it is necessary to ensure that the guide wire reaches the main pancreatic duct, especially in patients with chronic pancreatitis.

Update on Pancreatobiliary Stents: Stent Placement in Advanced Hilar Tumors

Palliative drainage is the main treatment option for inoperable hilar cholangiocarcinoma to improve symptoms, which include cholangitis, pruritus, high-grade jaundice, and abdominal pain. Although there is no consensus on the optimal method for biliary drainage due to the paucity of large-scale randomized control studies, several important aspects of any optimal method have been studied. In this review article, we discuss the liver volume to be drained, stent type, techniques to insert self-expanding metal stents, and approaches for proper and effective biliary drainage based on previous studies and personal experience.

Update on Pancreatobiliary Stents: Stent Placement in Advanced Hilar Tumors

Palliative drainage is the main treatment option for inoperable hilar cholangiocarcinoma to improve symptoms, which include cholangitis, pruritus, high-grade jaundice, and abdominal pain. Although there is no consensus on the optimal method for biliary drainage due to the paucity of large-scale randomized control studies, several important aspects of any optimal method have been studied. In this review article, we discuss the liver volume to be drained, stent type, techniques to insert self-expanding metal stents, and approaches for proper and effective biliary drainage based on previous studies and personal experience.