Peroral endoscopic myotomy: 10-year outcomes from a large, single-center U.S. series with high follow-up completion and comprehensive analysis of long-term efficacy, safety, objective GERD, and endoscopic functional luminal assessment.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) is becoming the treatment of choice for achalasia. Data beyond 3 years are emerging but are limited. We herein report our 10-year experience, focusing on long-term efficacy and safety including the prevalence, management, and sequelae of postoperative reflux. METHODS: This was a single-center prospective cohort study. RESULTS: Six hundred ten consecutive patients received POEM from October 2009 to October 2019, 160 for type 1 achalasia (26.2%), 307 for type II (50.3%), 93 for type III (15.6%), 25 for untyped achalasia (4.1%), and 23 for nonachalasia disorders (3.8%). Two hundred ninety-two patients (47.9%) had prior treatment(s). There was no aborted POEM. Median operation time was 54 minutes. Accidental mucosotomies occurred in 64 patients (10.5%) and clinically significant adverse events in 21 patients (3.4%). No adverse events led to death, surgery, interventional radiology interventions/drains, or altered functional status. At a median follow-up of 30 months, 29 failures occurred, defined as postoperative Eckardt score >3 or need for additional treatment. The Kaplan-Meier clinical success estimates at years 1, 2, 3, 4, 5, 6, and 7 were 98%, 96%, 96%, 94%, 92%, 91%, and 91%, respectively. These are highly accurate estimates because only 13 patients (2%) were missing follow-up assessments. One hundred twenty-five patients (20.5%) had reflux symptoms more than once per week. At a median of 4 months, the pH study was completed in 406 patients (66.6%) and was positive in 232 (57.1%), and endoscopy was completed in 438 patients (71.8%) and showed reflux esophagitis in 218 (49.8%), mostly mild. CONCLUSIONS: POEM is exceptionally safe and highly effective on long-term follow-up, with >90% clinical success at ≥5 years.

Learning Curve for Endoscopic Submucosal Dissection With an Untutored, Prevalence-Based Approach in the United States.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is widely used in Asia to resect early-stage gastrointestinal neoplasms, but use of ESD in Western countries is limited. We collected data on the learning curve for ESD at a high-volume referral center in the United States to guide development of training programs in the Americas and Europe. METHODS: We performed a retrospective analysis of consecutive ESDs performed by a single operator at a high-volume referral center in the United States from 2009 through 2017. ESD was performed in 540 lesions: 449 mucosal (10% esophageal, 13% gastric, 5% duodenal, 62% colonic, and 10% rectal) and 91 submucosal. We estimated case volumes required to achieve accepted proficiency benchmarks (>90% for en bloc resection and >80% for histologic margin-negative (R0) resection) and resection speeds >9cm2/hr. RESULTS: Pathology analysis of mucosal lesions identified 95 carcinomas, 346 premalignant lesions, and 8 others; the rate of en bloc resection increased from 76% in block 1 (50 cases) to a plateau of 98% after block 5 (250 cases). The rate of R0 resection improved from 45% in block 1 to >80% after block 5 (250 cases) and ∼95% after block 8 (400 cases). Based on cumulative sum analysis, approximately 170, 150, and 280 ESDs are required to consistently achieve a resection speed >9cm2/hr in esophagus, stomach, and colon, respectively. CONCLUSIONS: In an analysis of ESDs performed at a large referral center in the United States, we found that an untutored, prevalence-based approach allowed operators to achieve all proficiency benchmarks after ∼250 cases. Compared with Asia, ESD requires more time to learn in the West, where the untutored, prevalence-based approach requires resection of challenging lesions, such as colon lesions and previously manipulated lesions, in early stages of training.

Per-oral endoscopic myotomy in patients with or without prior Heller's myotomy: comparing long-term outcomes in a large U.S. single-center cohort (with videos).

BACKGROUND AND AIMS: Heller's myotomy (HM) is one of the most effective treatments for esophageal achalasia. However, failures do exist, and the success rate tends to decrease with time. The efficacy of rescue treatments for patients with failed HM is limited. A few small-scale studies have reported outcomes of per-oral endoscopic myotomy (POEM) in these patients. We conducted this study to systematically assess feasibility, safety, and efficacy of POEM on patients who have had HM. METHODS: Patients at least 3 months out from POEM were selected from our prospective database: 318 consecutive POEMs performed from October 2009 to October 2016. The efficacy and safety of POEM were compared between the 46 patients with prior HM and the remaining 272 patients. RESULTS: Patients with prior HM had longer disease history, more advanced disease, more type I and less type II achalasia, lower before-POEM Eckardt scores, and lower before-POEM lower esophageal sphincter (LES) pressure (all P < .01). Procedure parameters and follow-up results (clinical success rate, Eckardt score, LES pressure, GERD score, esophagitis, and pH testing) showed no significant difference between the 2 groups. For the 46 HM-POEM patients, no clinically significant perioperative adverse events occurred. Their overall clinical success rate (Eckardt score ≤3 and no other treatment needed) was 95.7% at a median follow-up of 28 months. CONCLUSION: POEM as a rescue treatment for patients with achalasia who failed HM is feasible, safe, and highly effective. It should be the treatment of choice in managing these challenging cases at centers with a high level of experience with POEM.

High yield of same-session EUS-guided liver biopsy by 19-gauge FNA needle in patients undergoing EUS to exclude biliary obstruction.

BACKGROUND: EUS-guided liver biopsy by Trucut yields variable specimen adequacy at high cost, limiting its utility. A modified EUS-guided technique with reliable adequacy could be a viable alternative to standard techniques in cost-effective clinical settings. OBJECTIVE: To describe our experience with EUS-guided liver biopsy by 19-gauge FNA, non-Trucut, needle in a cost-effective setting: patients with abnormal liver test results of unclear etiology referred for EUS to exclude biliary obstruction in whom an unrevealing EUS would have prompted a next-step liver biopsy by the referring physician. DESIGN: Prospective case series. SETTING: Tertiary-care teaching hospital. PATIENTS: Consecutive patients with abnormal liver tests referred for EUS. INTERVENTIONS: EUS-guided liver biopsy by 19-gauge FNA needle (non-Trucut). MAIN OUTCOME MEASUREMENTS: Diagnostic yield, specimen adequacy, and complications. An adequate specimen was defined as a length of 15 mm or longer and 6 or more complete portal tracts (CPTs). RESULTS: Between July 2008 and July 2011, 22 of 31 consecutive patients meeting inclusion criteria underwent unrevealing EUS with same-session EUS-guided liver biopsy by 19-gauge FNA needle. A median of 2 FNA passes (range 1-3) yielded a median specimen length of 36.9 mm (range 2-184.6 mm) with a median of 9 CPTs (range 1-73 CPTs). EUS-guided liver biopsies yielded a histologic diagnosis and adequate specimens in 20 of 22 patients (91%). Expanded experience led to improved specimen adequacy. There were no complications. LIMITATION: Small study size. CONCLUSIONS: EUS-guided liver biopsy by using a 19-gauge FNA needle appears to be feasible and safe and provides excellent diagnostic yield and specimen adequacy.

The appendix may protect against Clostridium difficile recurrence.

BACKGROUND & AIMS: Several risk factors have been identified for the development of recurrent Clostridium difficile infection (CDI) that alter host immunity and disrupt colonic flora. Although the function of the appendix has been debated, its active, gut-associated lymphoid tissue and biofilm production indicate potential roles in recovery from initial CDI and protection against recurrent CDI. We investigated whether the presence or absence of an appendix is associated with CDI recurrence. METHODS: We reviewed the medical records of adult inpatients with CDI who were admitted to a tertiary-care teaching hospital from 2005 to 2007 to identify those with and without an appendix. The primary dependent variable for statistical analysis was CDI recurrence. RESULTS: In a multivariate analysis of 11 clinical variables, the presence of an appendix was associated inversely with CDI recurrence (P < .0001; adjusted relative risk, .398). Age older than 60 years also was associated with CDI recurrence (P = .0280; adjusted relative risk, 2.44). CONCLUSIONS: The presence of an appendix has a significant and independent, inverse association with CDI recurrence, but this finding requires validation in a prospective study. Assessing the presence or absence of an appendix might be useful in predicting CDI recurrence.

Editorial: drug-induced acute pancreatitis: uncommon or commonplace?

Many drugs have been implicated as causing acute pancreatitis (AP), mainly based on the recurrence of pancreatitis following rechallenge with a drug that the patient had been taking at the time of an initial episode of AP. However, estimates of the relative frequency with which drugs cause AP vary widely. This is largely because many patients may be taking a number of drugs, may have co-morbidities such as gallstone disease or hypertriglyceridemia, or may be consuming large amounts of alcohol, making it difficult to determine what actually is the primary cause of an episode of AP. Large, rigorously designed epidemdiological studies are needed to better define the frequency with which the drugs in general cause AP and the specific risk of pancreatitis associated with any individual drug.

Pancreatic cystic neoplasms.

Pancreatic cysts include inflammatory lesions, low-grade neoplasms, and malignant neoplasms. Cystic neoplasms may prompt investigation because of symptoms such as abdominal pain, distension, jaundice, or nausea, but they are usually incidentally discovered. In the older literature, pseudocysts related to acute and chronic pancreatitis accounted for the majority of pancreatic cysts, but it is difficult to differentiate pancreatic cystic neoplasms from pseudocysts even with high-resolution modalities including computed tomography (CT) and magnetic resonance imaging (MRI) scans. Additionally, the more recent literature has shown that small pancreatic cystic lesions are relatively common as incidental findings on cross-sectional imaging examinations that are performed for other reasons, typically in older patients without prior episodes of pancreatitis; these are often low-grade mucinous lesions or occasionally epithelial cysts. Endoscopic ultrasound with fine-needle aspiration has emerged as a prime modality in delineating such cystic lesions. There has been an exponential increase in the more recent literature regarding pancreatic cystic lesions. The purpose of this review article is to provide a concise overview of these pancreatic cystic lesions.

Drug-induced pancreatitis : incidence, management and prevention.

Drugs are a relatively rare cause of acute pancreatitis, with an estimated incidence of 0.1-2%. Many drugs have been suspected of causing pancreatitis, but the true incidence is not known as the evidence is derived mainly from random case reports. Case reports with the strongest evidence are those that clearly diagnose pancreatitis and exclude common aetiologies, provide the dose and time interval between the start of treatment with the suspected drug and the development of pancreatitis, document response to withdrawal of the drug, and demonstrate recurrent pancreatitis upon rechallenge with the drug. Few data exist on the mechanisms of drug-induced pancreatitis. Certain subpopulations such as children, women, the elderly and patients with advanced HIV infection or inflammatory bowel disease may be at higher risk. The diagnosis of drug-induced pancreatitis is often challenging because there are no unique clinical characteristics to distinguish drugs from other causes of pancreatitis. The majority of cases are mild, but severe and even fatal cases may occur, thus making identification of the offending agent critical. Management of drug-induced acute pancreatitis requires withdrawal of the offending agent and supportive care. Prevention of drug-induced pancreatitis requires an up-to-date knowledge of drugs that have the strongest evidence linking their use to the development of pancreatitis as well as the proposed mechanisms through which they may cause the reaction. In this paper, the epidemiology, diagnosis, management and prevention of drug-induced pancreatitis is reviewed. Drugs and classes of drugs strongly implicated as causing acute pancreatitis, based on well documented case reports, are discussed in detail.

Corneal abrasion following anaesthesia for non-ocular surgical procedures: A case-controlled study.

The aim of this study was to identify risk factors associated with perioperative corneal abrasion at a single hospital in Mineola, New York (United States). A chart review was conducted of patients with perioperative corneal abrasion following non-ocular surgery and age-matched controls between June 2011 and November 2013. An age-stratified logistic regression model evaluated the association between corneal abrasion and potentially predisposing variables. The adjusted odds of a corneal abrasion occurring were 4.6 times greater for patients having surgery for ≥ 3 hours (p=0.001) and 3.6 times greater for patients with pre-existing ocular disease (p=0.02). Gender, diabetes status, surgical procedure or position were not found to be associated with the occurrence of a corneal abrasion. Corneal abrasions were associated with longer procedures and history of pre-existing ocular disease. No significant association between body positioning or surgical site and perioperative corneal abrasion was found. The study concludes that a longer duration of surgical procedure and pre-existing ocular disease are risk factors for perioperative corneal abrasion.

Endoscopic approaches to treatment of achalasia.

Endoscopic therapy for achalasia is directed at disrupting or weakening the lower esophageal sphincter (LES). The two most commonly utilized endoscopic interventions are large balloon pneumatic dilation (PD) and botulinum toxin injection (BTI). These interventions have been extensively scrutinized and compared with each other as well as with surgical disruption (myotomy) of the LES. PD is generally more effective in improving dysphagia in achalasia than BTI, with the latter reserved for infirm older people, and PD may approach treatment results attained with myotomy. However, PD may need to be repeated. Small balloon dilation and endoscopic stent placement for achalasia have only been used in select centers. Per oral endoscopic myotomy is a newer endoscopic modality that will likely change the treatment paradigm for achalasia. It arose from the field of natural orifice transluminal endoscopic surgery and represents a scarless endoscopic approach to Heller myotomy. This is a technique that requires extensive training and preparation and thus there should be rigorous accreditation and monitoring of outcomes to ensure safety and efficacy.

Outcomes of endoscopic-ultrasound-guided cholangiopancreatography: a literature review.

Endoscopic retrograde cholangiopancreatography (ERCP) can fail in 3-10% of the cases even in experienced hands. Although percutaneous transhepatic cholangiography (PTC) and surgery are the traditional alternatives, there are morbidity and mortality associated with both. In this paper, we have discussed the efficacy and safety of endoscopic-ultrasound-guided cholangiopancreatography (EUS-CP) in decompression of biliary and pancreatic ducts. The overall technical and clinical success rates are around 90% for biliary and 70% for pancreatic duct drainage. The overall EUS-CP complication rate is around 15%. EUS-CP is, however, a technically challenging procedure and should be performed by an experienced endoscopist skilled in both EUS and ERCP. Same session EUS-CP as failed initial ERCP is practical and may result in avoidance of additional procedures. With increasing availability of endoscopists trained in both ERCP and EUS, the role of EUS-CP is likely to grow in clinical practice.

Per-oral endoscopic myotomy for achalasia: An American perspective.

Achalasia is an uncommon esophageal motility disorder characterized by the selective loss of enteric neurons leading to absence of peristalsis and impaired relaxation of the lower esophageal sphincter. Per-oral endoscopic myotomy (POEM) is a novel modality for the treatment of achalasia performed by gastroenterologists and surgeons. It represents a natural orifice transluminal endoscopic surgery (NOTES) approach to Heller myotomy. POEM has the minimal invasiveness of an endoscopic procedure that can duplicate results of the surgical Heller myotomy. POEM is conceptually similar to a surgical myotomy without the inherent external incisions and post-operative care associated with surgery. Initial high success and low complications rates promise a great future for this technique. In fact, POEM has been successfully performed on patients with end-stage achalasia as an initial treatment reserving esophagectomy for those without good response. The volume of POEMs performed worldwide has grown exponentially. In fact, surgeons who have performed Heller myotomy have embraced POEM as the preferred intervention for achalasia. However, the niche of POEM remains to be defined and long term results are awaited. We describe our experience with POEM having performed the first POEM outside of Japan in 2009, the evolution of our technique, and give our perspective on its future.

Endoscopist's approach to nutrition in the patient with pancreatitis.

Nutritional therapy has an important role in the management of patient with severe acute pancreatitis. This article reviews the endoscopist's approach to manage nutrition in such cases. Enteral feeding has been clearly validated as the preferred route of feeding, and should be started early on admission. Parenteral nutrition should be reserved for patients with contraindications to enteral feeding such as small bowel obstruction. Moreover, nasogastric feeding is safe and as effective as nasojejunal feeding. If a prolonged course of enteral feeding (> 30 d) is required, endoscopic placement of feeding gastrostomy or jejunostomy tubes should be considered.

Does deep sedation impact the results of 48 hours catheterless pH testing?

AIM: To study a cohort of patients undergoing 48 h Bravo pH testing receiving deep sedation with propofol. METHODS: We retrospectively reviewed the charts of 197 patients (81 male, 116 female) who underwent Bravo esophageal pH monitoring from July 2003 to January 2008. All patients underwent Bravo pH probe placement via esophagogastroduodenoscopy (EGD) and received propofol for sedation. Patients on a proton pump inhibitor (89 patients) were excluded. Acid reflux variables measured included the total, upright, and supine fractions of time at pH < 4 and DeMeester score, and were compared between day 1 and day 2. RESULTS: Of the 108 patients that were included in the study, the most common indication for Bravo pH monitoring was heartburn, with chest pain being the second most common. A signed rank test revealed no statistically significant difference between day 1 and day 2 reflux episodes. CONCLUSION: Patients who received propofol for sedation for EGD with Bravo pH capsule placement did not experience any significant difference in reflux episodes from day 1 to day 2.

Where have all the dreiling tubes gone?

The direct measurement of pancreatic function remains the best tool for diagnosing chronic pancreatitis, especially if imaging tests are normal or inconclusive. The most effective means of measuring pancreatic function is the standard hormone stimulation test using secretin. Traditionally, direct pancreatic function testing involves the fluoroscopic placement of an oroduodenal tube and collection of duodenal fluid containing pancreatic secretions after administration of a standardized dose of secretin and/or CCK. The test is time-consuming and tedious to perform, and placement of the oroduodenal tube is often difficult for the person performing the test and uncomfortable for the patient. Bicarbonate concentration typically has been measured by back-titration, requiring specialized equipment no longer found in most hospital clinical chemistry laboratories. For these reasons, the direct testing of pancreatic function after secretin stimulation has become a much admired but rarely performed test, currently done in only a few centers in the United States. In this issue of the Journal, Stevens et al. report on a cross-over study of secretin-stimulated endoscopic pancreatic function test (ePFT) and dreiling tube pancreatic function test (D-PFT) in healthy subjects and demonstrate that the accuracy of the ePFT is comparable to that of the D-PFT (17). They have demonstrated the relative simplicity and reliability of ePFT, bringing it closer to the diagnostic armamentarium of the practicing physician. We may have lost the Dreiling tube but, in its place, gained a "gold standard" which will be more widely used.

Is pylorospasm a cause of delayed gastric emptying after pylorus-preserving pancreaticoduodenectomy?

BACKGROUND: Delayed gastric emptying (DGE) occurs in 14% to 61% of patients after pylorus-preserving pancreaticoduodenectomy, but its pathogenesis is unclear. We hypothesized that DGE may be due to pylorospasm secondary to vagal injuries at operation and may be preventable by the addition of pyloromyotomy. METHODS: Patients operated on consecutively between April 2000 and August 2003 were studied. Pyloromyotomy was of the Fredet-Ramstedt type combined with antroplasty. DGE-free recovery was defined as tolerance of a diet for three successive days by postoperative day 8. The symptom of nausea was used as a basis for nasogastric tube removal and diet resumption. A gastric emptying test (GET) with solid food was obtained. Patients with difficulty swallowing were fed via a feeding tube. RESULTS: There were 47 patients. Two patients were excluded because of death (n = 1) and ileus with pancreatic fistula (n = 1). Diagnoses were pancreatic cancer (n = 23), chronic pancreatitis (n = 11), ampullary cancer (n = 5), mucinous cystic neoplasm (n = 5), and duodenal villous adenoma (n = 3). Median times to nasogastric tube removal, start of liquid diet, and start of solid diet were postoperative days 2, 3, and 5, respectively. Two patients had tube feedings. Preoperative GET was abnormal in 51%, and postoperative GET was abnormal in 37%. The average length of stay was 9.5 days (median, 7 days). DGE occurred in only one patient (2.2%). There were no late complications during a 6-month follow-up. CONCLUSIONS: The addition of pyloromyotomy to pylorus-preserving pancreaticoduodenectomy is effective in preventing DGE. Results are supportive of the hypothesis that DGE may be caused by operative injuries of the vagus innervating the pyloric region.