Dysplasia severity is associated with poor quality of life in patients with Barrett's esophagus referred for endoscopic eradication therapy.

Limited data exist regarding patient-reported outcomes and quality of life (QOL) experienced by patients with Barrett's esophagus (BE) referred for endoscopic eradication therapy (EET). Specifically, the impact of grade of dysplasia has not been explored. The purpose of this study is to measure patient-reported symptoms and QOL and identify factors associated with poor QOL in BE patients referred for EET. This was a prospective multicenter study conducted from January 2015 to October 2017, which included patients with BE referred for EET. Participants completed a set of validated questionnaires to measure QOL, symptom severity, and psychosocial factors. The primary outcome was poor QOL defined by a PROMIS score >12. Multivariable logistic regression analysis was performed to identify factors associated with poor QOL. In total, 193 patients participated (mean age 64.6 years, BE length 5.5 cm, 82% males, 92% Caucasians) with poor QOL reported in 104 (53.9%) participants. On univariate analysis, patients with poor QOL had lower use of twice daily proton pump inhibitor use (61.5% vs. 86.5%, P = 0.03), shorter disease duration (4.9 vs. 5.9 years, P = 0.04) and progressive increase in grade of dysplasia (high-grade dysplasia: 68.8% vs. 31.3%, esophageal adenocarcinoma: 75.5% vs. 24.5%, P < 0.001). Multivariate analysis demonstrated that high-grade dysplasia was independently associated with poor QOL (OR: 5.57, 95% CI: 1.05, 29.5, P = 0.04). In summary, poor QOL is experienced by the majority of patients with BE referred for EET and the degree of dysplasia was independently associated with poor QOL, which emphasizes the need to incorporate patient-centered outcomes when studying treatment of BE-related dysplasia.

The impact of endoscopic ultrasonography with fine needle aspiration (EUS-FNA) on esophageal cancer staging: a survey of thoracic surgeons and gastroenterologists.

SUMMARY: Accurate staging of esophageal cancer is critical to achieving optimal treatment outcomes. End-oscopic ultrasound with fine needle aspiration (EUS-FNA) has emerged as a valuable tool for locoregional staging. However, it is unclear how different physician specialties perceive the benefit of EUS-FNA for esophageal cancer staging, and thus utilize this modality in clinical practice. A survey regarding utilization of EUS-FNA in esophageal cancer was distributed to 211 thoracic surgeons and 251 EUS-capable gastroenterologists. Seventy-six thoracic surgeons (36%) and 78 gastroenterologists (31%) responded to the survey. Most surgeons (75%) use EUS to stage potentially resectable esophageal cancer 75% of the time. Surgeons using EUS less often are less likely to have access to high-quality EUS services than their peers. Fewer surgeons believe EUS is the most accurate test for T and N-staging (84% and 71%, respectively) as compared with gastroenterologists (97% and 96%, P < 0.01 for both). Most endosonographers (68%) decide whether to dilate a malignant esophageal stricture to complete the staging exam on a case-by-case basis. Surgeons disagree as to whether involvement of celiac lymph nodes should preclude esophagectomy in distal esophageal cancer. While most thoracic surgeons have embraced EUS-FNA as the most accurate locoregional staging modality in esophageal cancer, this attitude is not fully reflected in utilization patterns due to a lack of quality EUS services in some centers. Controversial areas that warrant further study include dilation of malignant strictures to facilitate EUS staging, and the implication of involved celiac lymph nodes on management.

Safety, feasibility and weight loss after transoral gastroplasty: First human multicenter study.

OBJECTIVE: To evaluate the safety and feasibility in human subjects of a new transoral restrictive procedure for the treatment of obesity. METHODS: The protocol was approved by the institutional review boards (IRBs) of both centers involved, and all patients gave informed consent. Patients met established inclusion criteria for bariatric surgery. The TOGa system (Satiety Inc., Palo Alto, CA), a set of transoral endoscopically guided staplers, was used to create a stapled restrictive pouch along the lesser curve of the stomach. Patients were hospitalized overnight for observation and underwent barium upper gastrointestinal (UGI) the next morning. Post procedure, all patients were placed on a liquid diet for 1 month and asked to begin an exercise program. Follow-up was carried out at 1 week and 1, 3, 4, 5, and 6 months. RESULTS: Twenty one patients were enrolled [17 female, age 43.7 (22-57) years, BMI 43.3 (35-53) kg/m(2)]. Device introduction was completed safely in all patients. There were no serious adverse events (AEs). The most commonly reported procedure or device related adverse events were vomiting, pain, nausea, and transient dysphagia. At 6 month endoscopy, all patients had persistent full or partial stapled sleeves. Gaps in the staple line were evident in 13 patients. Patients lost an average 17.6 pounds at 1 month, 24.5 pounds at three months, and 26.5 pounds at 6 months post-treatment [excess weight loss (EWL) of 16.2%, 22.6%, and 24.4%, respectively]. CONCLUSIONS: There is great interest in new procedures for morbid obesity that could offer lower morbidity than current options. Early experience with the TOGa procedure indicates that this transoral approach may be safe and feasible. Further experience with the device and technique should improve anatomic and functional outcomes in the future. Additional studies are underway.

Radiofrequency energy delivery to the gastroesophageal junction for the treatment of GERD.

BACKGROUND: In this multi-center study, the feasibility, safety, and efficacy of radiofrequency (RF) energy delivery to the gastroesophageal junction (GEJ) for the treatment of gastroesophageal reflux disease (GERD) were investigated. METHODS: Forty-seven patients with classic symptoms of GERD (heartburn and/or regurgitation), a daily anti-secretory medication requirement, and at least partial symptom response to drugs were enrolled. All patients had pathologic esophageal acid exposure by 24-hour pH study, a 2 cm or smaller hiatal hernia, grade 2 or less esophagitis, and no significant dysmotility or dysphagia. RF energy was delivered with a catheter and thermocouple-controlled generator to create submucosal thermal lesions in the muscle of the GEJ. GERD symptoms and quality of life were assessed at 0, 1, 4, and 6 months with the short-form health survey (SF-36). Anti-secretory medications were withdrawn 7 days before each assessment of symptoms and pH/motility study. Medication use, endoscopic findings, esophageal acid exposure, and motility were assessed at 0 and 6 months. RESULTS: Thirty-two men and 15 women underwent treatment. At 6 months there were improvements in the median heartburn score (4 to 1, p < or = 0.0001), GERD score (26 to 7, p < or = 0.0001), satisfaction (1 to 4, p < or = 0.0001), mental SF-36 (46.2 to 55.5, p = 0.01), physical SF-36 (41.1 to 51.9, p < or = 0.0001), and esophageal acid exposure (11.7% to 4.8%, p < or = 0.0001). Esophagitis was present in 25 patients before treatment (15 grade 1 and 10 grade 2) and 8 had esophagitis at 6 months (4 grade 1 and 4 grade 2, p = 0.005). At 6 months, 87% no longer required proton pump inhibitor medication. There was no significant change in median lower esophageal sphincter pressure (14.0 to 12.0 mm Hg, p = 0.19), peristaltic amplitude (64 to 66 mm Hg, p = 0.71), or lower esophageal sphincter length (3.0 to 3.0, p = 0.28). There were 3 self-limited complications (fever for 24 hours, odynophagia lasting for 5 days, and a linear mucosal injury that was healed after 3 weeks). CONCLUSION: RF energy delivery significantly improved GERD symptoms, quality of life, and esophageal acid exposure while eliminating the need for anti-secretory medication in the majority of patients with a heterogeneous spectrum of clinical disease severity but with minimal active esophagitis or hiatal hernia.

Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial.

BACKGROUND: A totally transoral outpatient procedure for the treatment of GERD would be appealing. METHODS: A multicenter trial was initiated that included 64 patients with GERD treated with an endoscopic suturing device. Inclusion criteria were 3 or more heartburn episodes per week while not taking medication, dependency on antisecretory medicine, and documented acid reflux by pH monitoring. Exclusion criteria were dysphagia, grade 3 or 4 esophagitis, obesity, and hiatus hernia greater than 2 cm in length. Patients underwent manometry, endoscopy, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patients were randomized to a linear or circumferential plication configuration. Adverse procedural events were recorded. RESULTS: Mean 6-month symptom score changes demonstrated procedural efficacy. Heartburn severity and frequency as well as regurgitation all improved (p > 0.0001 for each). Twenty-four-hour pH monitoring showed improvement in number of episodes below pH of 4 at 3 and 6 months (p < 0.0007 and 0.0002) and percentage of total time the pH was less than 4 at 6 months (p < 0.011). Plication configuration did not affect symptoms or pH monitoring results. One patient had a self-contained suture perforation that was successfully treated with antibiotics. CONCLUSION: Endoscopic gastroplasty is safe. It is associated with reduced symptoms and medication use at 6 month follow-up in patients with uncomplicated GERD.

Acute gastrointestinal bleeding.

Acute gastrointestinal bleeding is a significant worldwide medical problem. Despite modern measures for diagnosis and treatment, morbidity and mortality rates associated with gastrointestinal bleeding remain largely unchanged. Aggressive medical resuscitation while initiating an evaluation to localize the site of blood loss remains the key to successful management of acute gastrointestinal bleeding. A multidisciplinary approach with early involvement of a gastroenterologist, surgeon, and radiologist can be extremely helpful in the management of these patients. With the logical and direct approach to the evaluation of patients with gastrointestinal bleeding described in this article, most episodes can be managed successfully.

Endoscopic management of bile duct leaks after attempted laparoscopic cholecystectomy.

Fourteen patients with symptomatic bile duct leaks following laparoscopic cholecystectomy were treated using endotherapeutic techniques. Patients presented with abdominal pain, liver test abnormalities, jaundice, leukocytosis, and fever. Twelve leaks originated from cystic duct stumps and two from right posterior hepatic ducts. Distal biliary obstruction, which may have promoted leakage, was present in five patients. Treatment methods included stent insertion with endoscopic sphincterotomy (ES), stent insertion without ES, and nasobiliary tube (NBT) placement without ES. Eleven of 14 patients had prompt resolution of their bile leaks following initial endotherapy. Three patients with continued leakage underwent successful repeat endoscopic retrograde cholangiopancreatography 4-5 days after the initial examination. Cholangiographic evidence of leak closure was documented in all patients, and all remained asymptomatic during an average follow-up period of 18.5 months. Endoscopic therapy is safe and effective treatment for clinically significant bile leaks following laparoscopic cholecystectomy. In our small group of patients, NBT alone did not appear to be as effective as endoprostheses with or without ES. The ideal endoscopic treatment method has not yet been established but will likely vary depending on the site and specific nature of the injury and any concomitant biliary ductal pathology.

Complications of percutaneous endoscopic gastrostomy.

Percutaneous endoscopic gastrostomy has become the procedure of choice for the establishment of enteral feedings in most clinical settings. Minor modifications in the technique and tools of PEG may have had some effect on the type of complications seen with this procedure. The major and minor complications of PEG are reviewed with a focus on those manipulations that may assist in reducing the incidence of common complications of this procedure.

Percutaneous gallstone removal: long-term follow-up.

PURPOSE: To evaluate gallstone and symptom recurrence rates, long-term complications, and life expectancy after percutaneous gallstone removal. PATIENTS AND METHODS: Medical records of 87 patients (mean age, 69 years +/- 14 [standard deviation]) undergoing percutaneous gallstone removal between 1987 and 1992 were reviewed. Physicians and patients (or their families) were contacted for clinical follow-up. Thirty-one patients returned for follow-up ultrasound (US). RESULTS: The final study group consisted of 65 patients. Mean survival from the time of initial gallbladder drainage was 33 months +/- 19. Over a mean clinical follow-up period of 33 months, eight of 65 patients (12%) developed recurrent symptoms; six of these eight had recurrent gallstones shown at US. Of 30 patients with technically adequate US images (mean follow-up, 14 months +/- 12), 12 (40%) had recurrent gallstones. Six of these 12 patients had recurrent symptoms. No long-term complications were identified. CONCLUSION: The risk of gallstone recurrence after percutaneous removal is notable, but the symptom recurrence rate is much lower. Percutaneous gallstone removal is beneficial for patients at prohibitive surgical or general anesthetic risk.

Technology assessment status evaluation: balloon dilation of gastrointestinal tract strictures. American Society for Gastrointestinal Endoscopy.

Balloon dilation is an acceptable modality for the dilation of stenoses at various sites in the gastrointestinal tract. In the esophagus its reported efficacy and safety is similar to bougienage; in other sites it offers an alternative to surgical treatment, in most cases as the definitive therapy.

Technology assessment status evaluation: monitoring equipment for endoscopy. American Society for Gastrointestinal Endoscopy.

An understanding of the principles and limitations of monitoring devices is valuable for their appropriate use and interpretation. Reliable monitoring de available as an adjunct to skilled personnel to detect changes in patient condition during endoscopy. Combination units that provide pulse oximetry, automated sphygmomanometry and ECG monitoring appear to be the most convenient and cost effective products.

Technology assessment status evaluation: disposable endoscopic accessories. American Society for Gastrointestinal Endoscopy.

Data supporting the preferential use of disposable endoscopic accessories is limited. These devices have been widely disseminated without careful evaluation of their impact on the environment and medical costs. In addition, current facility reimbursement for endoscopic procedures does not adequately cover the costs of these accessories. Re-use of accessories labelled "for single use only" as a potential means to reduce costs has not been carefully evaluated. More prospective data comparing the efficacy, safety, and cost effectiveness of disposable versus reusable accessories is needed.

Washington University experience with extracorporeal shock-wave lithotripsy of pancreatic duct calculi.

OBJECTIVES: To ascertain the effectiveness and safety of extracorporeal shock-wave lithotripsy (ESWL) for pancreatic calculi. METHODS: Fourteen ESWL treatments were performed in 12 patients with chronic pancreatitis. RESULTS: Fragmentation was perceptible after 13 of 14 treatments. Subsequent endoscopic manipulation resulted in complete extraction, partial extraction, and failed extraction of the fragments after 7, 4, and 2 of the ESWL treatments, respectively. No complications occurred and no patient had pancreatitis following ESWL. At a median follow-up of 19 to 22 months, 4 patients have had complete relief of symptoms, 4 have had a decrease in both severity and frequency of pain, and 4 have had no improvement. CONCLUSIONS: ESWL is a safe and useful noninvasive adjunct in the treatment of patients with pancreatic duct calculi.

Common bile duct stones.

Endoscopic ultrasonography (EUS) is a sensitive and specific modality for the detection of choledocholithiasis. In experienced hands, it can be completely effective in almost all patients without significant risk. Prospective studies have shown that the sensitivity and specificity of EUS for the detection of choledocholithiasis rival that of ERCP. The clinical roles for EUS in these settings are currently evolving and will also likely be shaped by the continued forces to practice the most effective medicine.

A comparison of nonionic versus ionic contrast media: results of a prospective, multicenter study. Midwest Pancreaticobiliary Study Group.

BACKGROUND: Pancreatitis is one of the most common complications associated with ERCP. Multiple factors have been implicated for this potentially serious complication. Numerous suggestions for minimizing risks at ERCP have been offered, one of which is to use nonionic, low osmolarity contrast agents for pancreatic injection. Results of previous studies comparing different contrast media have been inconclusive. METHODS: To evaluate the role contrast material plays in the development of post-ERCP pancreatitis, the Midwest Pancreaticobiliary Group performed a prospective double-blind controlled study. A total of 1,979 consecutive ERCP patients were enrolled, and 1,659 patients with pancreatic duct injections were divided into subgroups according to the complexity of the ERCP. Post-ERCP pancreatitis was compared between similar groups. Patients were randomized to receive injections of nonionic, low osmolarity contrast or standard ionic contrast media. RESULTS: The overall incidence of post-procedural pancreatitis was 10.2%. Those with diagnostic ERCP had the lowest incidence at 5.6%. Therapeutic procedures (12.3%) and sphincter of Oddi manometry (15.2%) had higher rates. Those injected with standard (ionic) contrast had an incidence of 10.4% and after injection with lower osmolar (nonionic) contrast, there was a 10% post-procedural pancreatitis rate. CONCLUSIONS: Patients with more complex procedures develop pancreatitis more frequently. The use of low osmolar (nonionic) contrast media does not decrease the incidence of post-ERCP pancreatitis.

Role of laparoscopic cholecystectomy in the management of acute gallstone pancreatitis.

Laparoscopic cholecystectomy has rapidly become the prime modality for removal of the gallbladder. However, as laparoscopic techniques for treating choledocholithiasis are evolving, we reviewed our experience with acute gallstone pancreatitis since the inception of laparoscopic cholecystectomy. Between November 1989 and March 1993, we treated 57 patients with acute gallstone pancreatitis. Cholecystectomy was performed during the initial admission in 46 patients (81%, group I), while 11 (19%) underwent delayed cholecystectomy at a second admission 2 to 9 weeks later (group II). Within group I, eight patients (17%) were thought to have contraindications to laparoscopic cholecystectomy and underwent open cholecystectomy. In the remaining 38 patients of group I, laparoscopic cholecystectomy was completed successfully. Preoperative endoscopic retrograde cholangiopancreatography (ERCP) was performed in 23 of these patients (61%) and endoscopic sphincterotomy was performed in 6 patients (26%). In four other patients, the intraoperative cholangiogram revealed common bile duct stones that were removed using laparoscopic techniques. The 11 patients in group II were all treated by laparoscopic cholecystectomy; of these patients, 3 underwent preoperative endoscopic stone removal and 1 had choledocholithiasis managed laparoscopically. Postoperative hospitalization averaged 4 +/- 1 days (mean +/- SEM), and there was no major morbidity or 30-day mortality. This is the first large series of acute gallstone pancreatitis in the era of laparoscopic cholecystectomy. Our experience suggests that laparoscopic cholecystectomy with or without ERCP should be the primary approach for treating acute gallstone pancreatitis in the 1990s.