Consensus guidelines on the role of cholangioscopy to diagnose indeterminate biliary stricture.

BACKGROUND: Indeterminate strictures pose a therapeutic dilemma. In recent years, cholangioscopy has evolved and the availability of cholangioscopy has increased. However, the position of cholangioscopy in the diagnostic algorithm to diagnose malignancy have not been well established. We aim to develop a consensus statement regarding the clinical role of cholangioscopy in the diagnosis of indeterminate biliary strictures. METHODS: The international experts reviewed the evidence and modified the statements using a three-step modified Delphi method. Each statement achieves consensus when it has at least 80% agreement. RESULTS: Nine final statements were formulated. An indeterminate biliary stricture is defined as that of uncertain etiology under imaging or tissue diagnosis. When available, cholangioscopic assessment and guided biopsy during the first round of ERCP may reduce the need to perform multiple procedures. Cholangioscopy are helpful in diagnosing malignant biliary strictures by both direct visualization and targeted biopsy. The absence of disease progression for at least 6 months is supportive of non-malignant etiology. Direct per-oral cholangioscopy provides the largest accessory channel, better image definition, with image enhancement but is technically demanding. Image enhancement during cholangioscopy may increase the diagnostic sensitivity of visual impression of malignant biliary strictures. Cholangioscopic imaging characteristics including tumor vessels, papillary projection, nodular or polypoid mass, and infiltrative lesions are highly suggestive for neoplastic/malignant biliary disease. The risk of cholangioscopy related cholangitis is higher than in standard ERCP, necessitating prophylactic antibiotics and ensuring adequate biliary drainage. Per-oral cholangioscopy may not be the modality of choice in the evaluation of distal biliary strictures due to inherent technical difficulties. CONCLUSION: Evidence supports that cholangioscopy has an adjunct role to abdominal imaging and ERCP tissue acquisition in order to evaluate and diagnose indeterminate biliary strictures.

An international, multi-institution survey on performing EUS-FNA and fine needle biopsy.

BACKGROUND AND OBJECTIVES: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and fine needle biopsy (FNB) are effective techniques that are widely used for tissue acquisition. However, it remains unclear how to obtain high-quality specimens. Therefore, we conducted a survey of EUS-FNA and FNB techniques to determine practice patterns worldwide and to develop strong recommendations based on the experience of experts in the field. METHODS: This was a worldwide multi-institutional survey among members of the International Society of EUS Task Force (ISEUS-TF). The survey was administered by E-mail through the SurveyMonkey website. In some cases, percentage agreement with some statements was calculated; in others, the options with the greatest numbers of responses were summarized. Another questionnaire about the level of recommendation was designed to assess the respondents' answers. RESULTS: ISEUS-TF members developed a questionnaire containing 17 questions that was sent to 53 experts. Thirty-five experts completed the survey within the specified period. Among them, 40% and 54.3% performed 50-200 and more than 200 EUS sampling procedures annually, respectively. Some practice patterns regarding FNA/FNB were recommended. CONCLUSION: This is the first worldwide survey of EUS-FNA and FNB practice patterns. The results showed wide variations in practice patterns. Randomized studies are urgently needed to establish the best approach for optimizing the FNA/FNB procedures.

Recovery of endoscopy services in the era of COVID-19: recommendations from an international Delphi consensus.

The COVID-19 pandemic has had a profound impact on provision of endoscopy services globally as staff and real estate were repurposed. As we begin to recover from the pandemic, a cohesive international approach is needed, and guidance on how to resume endoscopy services safely to avoid unintended harm from diagnostic delays. The aim of these guidelines is to provide consensus recommendations that clinicians can use to facilitate the swift and safe resumption of endoscopy services. An evidence-based literature review was carried out on the various strategies used globally to manage endoscopy during the COVID-19 pandemic and control infection. A modified Delphi process involving international endoscopy experts was used to agree on the consensus statements. A threshold of 80% agreement was used to establish consensus for each statement. 27 of 30 statements achieved consensus after two rounds of voting by 34 experts. The statements were categorised as pre-endoscopy, during endoscopy and postendoscopy addressing relevant areas of practice, such as screening, personal protective equipment, appropriate environments for endoscopy and infection control precautions, particularly in areas of high disease prevalence. Recommendations for testing of patients and for healthcare workers, appropriate locations of donning and doffing areas and social distancing measures before endoscopy are unique and not dealt with by any other guidelines. This international consensus using a modified Delphi method to produce a series of best practice recommendations to aid the safe resumption of endoscopy services globally in the era of COVID-19.

An international, multi-institution survey of the use of EUS in the diagnosis of pancreatic cystic lesions.

BACKGROUND AND OBJECTIVES: Currently, pancreatic cystic lesions (PCLs) are recognized with increasing frequency and have become a more common finding in clinical practice. EUS is challenging in the diagnosis of PCLs and evidence-based decisions are lacking in its application. This study aimed to develop strong recommendations for the use of EUS in the diagnosis of PCLs, based on the experience of experts in the field. METHODS: A survey regarding the practice of EUS in the evaluation of PCLs was drafted by the committee member of the International Society of EUS Task Force (ISEUS-TF). It was disseminated to experts of EUS who were also members of the ISEUS-TF. In some cases, percentage agreement with some statements was calculated; in others, the options with the greatest numbers of responses were summarized. RESULTS: Fifteen questions were extracted and disseminated among 60 experts for the survey. Fifty-three experts completed the survey within the specified time frame. The average volume of EUS cases at the experts' institutions is 988.5 cases per year. CONCLUSION: Despite the limitations of EUS alone in the morphologic diagnosis of PCLs, the results of the survey indicate that EUS-guided fine-needle aspiration is widely expected to become a more valuable method.

Endoscopic ultrasound elastography of small solid pancreatic lesions: a multicenter study.

BACKGROUND: The prevalence of malignancy in patients with small solid pancreatic lesions is low; however, early diagnosis is crucial for successful treatment of these cases. Therefore, a method to reliably distinguish between benign and malignant small solid pancreatic lesions would be highly desirable. We investigated the role of endoscopic ultrasound (EUS) elastography in this setting. METHODS: Patients with solid pancreatic lesions ≤ 15 mm in size and a definite diagnosis were included. Lesion stiffness relative to the surrounding pancreatic parenchyma, as qualitatively assessed and documented at the time of EUS elastography, was retrospectively compared with the final diagnosis obtained by fine-needle aspiration/biopsy or surgical resection. RESULTS: 218 patients were analyzed. The average size of the lesions was 11 ± 3 mm; 23 % were ductal adenocarcinoma, 52 % neuroendocrine tumors, 8 % metastases, and 17 % other entities; 66 % of the lesions were benign. On elastography, 50 % of lesions were stiffer than the surrounding pancreatic parenchyma (stiff lesions) and 50 % were less stiff or of similar stiffness (soft lesions). High stiffness of the lesion had a sensitivity of 84 % (95 % confidence interval 73 % - 91 %), specificity of 67 % (58 % - 74 %), positive predictive value (PPV) of 56 % (50 % - 62 %), and negative predictive value (NPV) of 89 % (83 % - 93 %) for the diagnosis of malignancy. For the diagnosis of pancreatic ductal adenocarcinoma, the sensitivity, specificity, PPV, and NPV were 96 % (87 % - 100 %), 64 % (56 % - 71 %), 45 % (40 % - 50 %), and 98 % (93 % - 100 %), respectively. CONCLUSIONS: In patients with small solid pancreatic lesions, EUS elastography can rule out malignancy with a high level of certainty if the lesion appears soft. A stiff lesion can be either benign or malignant.

Asian consensus statements on endoscopic management of walled-off necrosis. Part 2: Endoscopic management.

Walled-off necrosis (WON) is a new term for encapsulated necrotic tissue after severe acute pancreatitis. Various terminologies such as pseudocyst, necroma, pancreatic abscess, and infected necrosis were previously used in the literature, resulting in confusion. The current and past terminologies must be reconciled to meaningfully interpret past data. Recently, endoscopic necrosectomy was introduced as a treatment option and is now preferred over surgical necrosectomy when the expertise is available. However, high-quality evidence is still lacking, and there is no standard management strategy for WON. The consensus meeting aimed to clarify the diagnostic criteria for WON and the role of endoscopic interventions in its management. In the Consensus Conference, 27 experts from eight Asian countries took an active role and examined key clinical aspects of WON diagnosis and endoscopic management. Statements were crafted based on literature review and expert opinion, employing the modified Delphi method. All statements were substantiated by the level of evidence and the strength of the recommendation. We created 27 consensus statements for WON diagnosis and management, including details of endoscopic procedures. When there was not enough solid evidence to support the statements, this was clearly acknowledged to facilitate future research. Proposed management strategies were formulated and are illustrated using flow charts. These recommendations, which are based on the best current scientific evidence and expert opinion, will be useful for guiding endoscopic management of WON. Part 2 of this statement focused on the endoscopic management of WON.

Asian consensus statements on endoscopic management of walled-off necrosis Part 1: Epidemiology, diagnosis, and treatment.

Walled-off necrosis (WON) is a relatively new term for encapsulated necrotic tissue after severe acute pancreatitis. Various terminologies such as pseudocyst, necroma, pancreatic abscess, and infected necrosis were previously used in the literature, resulting in confusion. The current and past terminologies must be reconciled to meaningfully interpret past data. Recently, endoscopic necrosectomy was introduced as a treatment option and is now preferred over surgical necrosectomy when the expertise is available. However, high-quality evidence is still lacking, and there is no standard management strategy for WON. The consensus meeting aimed to clarify the diagnostic criteria for WON and the role of endoscopic interventions in its management. In the Consensus Conference, 27 experts from eight Asian countries took an active role and examined key clinical aspects of WON diagnosis and endoscopic management. Statements were crafted based on literature review and expert opinion, employing the modified Delphi method. All statements were substantiated by the level of evidence and the strength of the recommendation. We created 27 consensus statements for WON diagnosis and management, including details of endoscopic procedures. When there was not enough solid evidence to support the statements, this was clearly acknowledged to facilitate future research. Proposed management strategies were formulated and are illustrated using flow charts. These recommendations, which are based on the best current scientific evidence and expert opinion, will be useful for guiding endoscopic management of WON. Part 1 of this statement focused on the epidemiology, diagnosis, and timing of intervention.

Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma.

Hilar cholangiocarcinoma (HCCA) is one of the most common types of hepatobiliary cancers reported in the world including Asia-Pacific region. Early HCCA may be completely asymptomatic. When significant hilar obstruction develops, the patient presents with jaundice, pale stools, dark urine, pruritus, abdominal pain, and sometimes fever. Because no single test can establish the definite diagnosis then, a combination of many investigations such as tumor markers, tissue acquisition, computed tomography scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography, endoscopic ultrasonography/intraductal ultrasonography, and advanced cholangioscopy is required. Surgery is the only curative treatment. Unfortunately, the majority of HCCA has a poor prognosis due to their advanced stage on presentation. Although there is no survival advantage, inoperable HCCA managed by palliative drainage may benefit from symptomatic improvement. Currently, there are three techniques of biliary drainage which include endoscopic, percutaneous, and surgical approaches. For nonsurgical approaches, stent is the most preferred device and there are two types of stents i.e. plastic and metal. Type of stent and number of stent for HCCA biliary drainage are subjected to debate because the decision is made under many grounds i.e. volume of liver drainage, life expectancy, expertise of the facility, etc. Recently, radio-frequency ablation and photodynamic therapy are promising techniques that may extend drainage patency. Through a review in the literature and regional data, the Asia-Pacific Working Group for hepatobiliary cancers has developed statements to assist clinicians in diagnosing and managing of HCCA. After voting anonymously using modified Delphi method, all final statements were determined for the level of evidence quality and strength of recommendation.

Endoscopic ultrasound-guided injection therapy for hepatobiliary disease.

Endoscopic ultrasound (EUS)-guided injection therapy is the new frontier in the management of patients with hepatobiliary disease. Celiac plexus block/neurolysis was the first form of injection therapy and has been validated in many subsequent trials. Cyst ablation therapy, fiducial insertion, angiography, portal hypertensive therapy, endoscopic portosystemic shunt creation, portal vein embolization and injection of chemotherapeutic/biologic agents for antitumor therapy are more recent uses and will be discussed. Celiac plexus neurolysis is currently well established in providing adjunct pain control in patients with advanced malignancy. There are limited data available for its use in benign conditions. EUS-guided ablative therapy for pancreatic cysts remains an area for future research but seems to have a role for small thin-walled non-septated cysts. EUS-guided implantation of fiducials is technically feasible but its exact impact on tumor regression is unknown. Several case reports have documented EUS-guided alcohol and thrombin injection into pseudoaneurysms and cyanoacrylate and coil embolization for variceal therapy. Injection of viral vectors and immunomodulating cell cultures as antitumor therapy has been described but the evidence is still preliminary and further data are awaited.

Endoscopic resection of benign tumors of the duodenal papilla without and with intraductal growth.

BACKGROUND: Endoscopic papillectomy of benign papillary tumor is still not widely practiced. Intraductal growth has been considered a contraindication for endoscopic therapy. This prospective study evaluates endoscopic papillectomy for treatment of benign papillary tumors without and with intraductal growth. METHODS: Monofilament snare and monopolar electrocoagulation were used for papillectomy. A 7F stent was placed in the pancreatic duct. Patients with distal intraductal growth underwent sphincterotomy and endoscopic resection after exclusion of more proximal growth. RESULTS: Between February 1985 and April 2004, 106 patients (109 lesions), 68 women, 38 men, median age 68 years (range 29-88 years) were included. Median tumor size was 2 cm (range 0.5-6 cm) with one session (range 1-8) required for removal. Nine patients had invasive carcinoma (8%). Surgery for incomplete removal or recurrence was performed in 12% of 75 patients without and 37% of 31 patients with intraductal growth (p < 0.01), respectively. Fifteen patients had recurrence (15%); but, only 4 required surgery. Endoscopic resection was curative (median follow-up, 43 months) in 83% without and 46% with intraductal growth (p < 0.001). CONCLUSIONS: Endoscopic papillectomy is safe and effective, and may be feasible in cases of intraductal growth. Surveillance and, if required, re-treatment are mandatory because of the risk of recurrence.

Aggressive endoscopic therapy for pancreatic necrosis and pancreatic abscess: a new safe and effective treatment algorithm (videos).

BACKGROUND: Pancreatic necrosis and pancreatic abscess are severe complications of acute pancreatitis. Surgery is associated with significant morbidity and mortality in these critically ill patients. Endoscopic therapy has the potential to offer a safer and more effective alternative treatment modality. However, its role needs to be further investigated. METHODS: This is a retrospective study of the outcome of consecutive patients with pancreatic necrosis and pancreatic abscess, all unfit to undergo surgery, who underwent a new aggressive endoscopic approach. The treatment includes (1) synchronous EUS-guided multiple transmural and/or transpapillary drainage procedures followed by balloon dilation of the cystogastrostoma or cystoduodenostoma, (2) daily endoscopic necrosectomy and saline solution lavage, and (3) sealing of pancreatic fistula by N-butyl-2-cyanoacrylate. RESULTS: Pancreatic necrosis and pancreatic abscesses were successfully drained in 13 patients, thus avoiding emergency surgery as an initial treatment. Surgery was completely avoided in 9 patients over a median follow-up of 8.3 months (range 3-81 months). Surgery was combined with endoscopic therapy in one patient because of abscess extension into the right paracolic gutter, which was not manageable by endoscopic drainage. Because of the "disconnected-duct syndrome," two patients later developed recurrent pseudocysts and underwent elective surgery. Complications included minor bleeding after balloon dilation and necrosectomy in 4 cases, which were self limiting or controlled endoscopically. CONCLUSIONS: This aggressive endoscopic approach shows promising results. It expands the potential for endoscopic treatment in patients with pancreatic necrosis and/or pancreatic abscess.

A new radial mechanical puncture echoendoscope: prospective comparison with standard linear and radial echoendoscopes in assessment of focal pancreatic lesions.

BACKGROUND: A new mechanical puncture-echoendoscope was evaluated by comparing it with conventional linear and radial echoendoscopes. The new instrument has a 300 degrees image field parallel to the axis of the echoendoscope, which could potentially improve accuracy and facilitate assessment of suspected pancreatic lesions before needle puncture. METHODS: Twenty consecutive patients with suspected pancreatic lesions were evaluated endosonographically, including fine needle aspiration (FNA). The initial assessment was performed by random selection of either the new instrument or the standard linear echoendoscope. After completing the assessment including FNA, the procedure with FNA was repeated with the other puncture echoendoscope. The findings with these 2 instruments were compared to those with the conventional radial scanning echoendoscope. RESULTS: FNA was performed in 17 patients with pancreatic head lesions. In 3 patients without a visible pancreatic mass lymph, nodes greater than 10 mm in diameter were aspirated. The ability to image the needle, number of punctures, and material obtained were comparable for both puncture echoendoscopes. There were no significant differences with regard to time required for FNA with both puncture echoendoscopes or in the assessment of surrounding structures with all 3 instruments. The results of cytopathologic evaluation of material obtained by FNA were similar in 15 cases. The new instrument could not be passed into the esophagus in 1 patient because of an esophageal stricture. CONCLUSIONS: The performance of the new mechanical puncture echoendoscope was satisfactory for assessment and FNA of pancreatic lesions. The additional use of the conventional radial scanning echoendoscope provided no advantage with regard to any parameter assessed.