Prospective evaluation of an assessment tool for technical performance of duodenoscopes.

OBJECTIVE: While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes. METHODS: An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach's coefficient alpha (α). The secondary outcome was validity of the assessment tool. RESULTS: The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach's coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores. CONCLUSIONS: The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533.

An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis.

BACKGROUND & AIMS: Infected necrotizing pancreatitis is a highly morbid disease with poor outcomes. Intervention strategies have progressed from open necrosectomy to minimally invasive approaches. We compared outcomes of minimally invasive surgery vs endoscopic approaches for patients with infected necrotizing pancreatitis. METHODS: We performed a single-center, randomized trial of 66 patients with confirmed or suspected infected necrotizing pancreatitis who required intervention from May 12, 2014, through March 24, 2017. Patients were randomly assigned to groups that received minimally invasive surgery (laparoscopic or video-assisted retroperitoneal debridement, depending on location of collection, n = 32) or an endoscopic step-up approach (transluminal drainage with or without necrosectomy, n = 34). The primary endpoint was a composite of major complications (new-onset multiple organ failure, new-onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, bleeding and perforation of a visceral organ) or death during 6 months of follow-up. RESULTS: The primary endpoint occurred in 11.8% of patients who received the endoscopic procedure and 40.6% of patients who received the minimally invasive surgery (risk ratio 0.29; 95% confidence interval 0.11-0.80; P = .007). Although there was no significant difference in mortality (endoscopy 8.8% vs surgery 6.3%; P = .999), none of the patients assigned to the endoscopic approach developed enteral or pancreatic-cutaneous fistulae compared with 28.1% of the patients who underwent surgery (P = .001). The mean number of major complications per patient was significantly higher in the surgery group (0.69 ± 1.03) compared with the endoscopy group (0.15 ± 0.44) (P = .007). The physical health scores for quality of life at 3 months was better with the endoscopic approach (P = .039) and mean total cost was lower ($75,830) compared with $117,492 for surgery (P = .039). CONCLUSIONS: In a randomized trial of 66 patients, an endoscopic transluminal approach for infected necrotizing pancreatitis, compared with minimally invasive surgery, significantly reduced major complications, lowered costs, and increased quality of life. Clinicaltrials.gov no: NCT02084537.

Mechanism, assessment and management of pain in chronic pancreatitis: Recommendations of a multidisciplinary study group.

DESCRIPTION: Pain in patients with chronic pancreatitis (CP) remains the primary clinical complaint and source of poor quality of life. However, clear guidance on evaluation and treatment is lacking. METHODS: Pancreatic Pain working groups reviewed information on pain mechanisms, clinical pain assessment and pain treatment in CP. Levels of evidence were assigned using the Oxford system, and consensus was based on GRADE. A consensus meeting was held during PancreasFest 2012 with substantial post-meeting discussion, debate, and manuscript refinement. RESULTS: Twelve discussion questions and proposed guidance statements were presented. Conference participates concluded: Disease Mechanism: Pain etiology is multifactorial, but data are lacking to effectively link symptoms with pathologic feature and molecular subtypes. Assessment of Pain: Pain should be assessed at each clinical visit, but evidence to support an optimal approach to assessing pain character, frequency and severity is lacking. MANAGEMENT: There was general agreement on the roles for endoscopic and surgical therapies, but less agreement on optimal patient selection for medical, psychological, endoscopic, surgical and other therapies. CONCLUSIONS: Progress is occurring in pain biology and treatment options, but pain in patients with CP remains a major problem that is inadequately understood, measured and managed. The growing body of information needs to be translated into more effective clinical care.

Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial.

BACKGROUND & AIMS: Although surgery is the standard technique for drainage of pancreatic pseudocysts, use of endoscopic methods is increasing. We performed a single-center, open-label, randomized trial to compare endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage. METHODS: Patients with pancreatic pseudocysts underwent endoscopic (n = 20) or surgical cystogastrostomy (n = 20). The primary end point was pseudocyst recurrence after a 24-month follow-up period. Secondary end points were treatment success or failure, complications, re-interventions, length of hospital stay, physical and mental health scores, and total costs. RESULTS: At the end of the follow-up period, none of the patients who received endoscopic therapy had a pseudocyst recurrence, compared with 1 patient treated surgically. There were no differences in treatment successes, complications, or re-interventions between the groups. However, the length of hospital stay was shorter for patients who underwent endoscopic cystogastrostomy (median, 2 days, vs 6 days in the surgery group; P < .001). Although there were no differences in physical component scores and mental health component scores (MCS) between groups at baseline on the Medical Outcomes Study 36-Item Short-Form General Survey questionnaire, longitudinal analysis showed significantly better physical component scores (P = .019) and mental health component scores (P = .025) for the endoscopy treatment group. The total mean cost was lower for patients managed by endoscopy than surgery ($7011 vs $15,052; P = .003). CONCLUSIONS: In a randomized trial comparing endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage, none of the patients in the endoscopy group had pseudocyst recurrence during the follow-up period, therefore there is no evidence that surgical cystogastrostomy is superior. However, endoscopic treatment was associated with shorter hospital stays, better physical and mental health of patients, and lower cost. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00826501.

Costs and risks in the management of patients with gastric acid hypersecretion.

GOALS: To define both risks and costs of optimal care of patients with gastric acid hypersecretion. BACKGROUND: The management of Zollinger-Ellison syndrome and other gastric acid hypersecretory disorders remains challenging. The optimal strategy for follow-up including gastric acid analysis, laboratory studies, and endoscopy is unknown but important given the potential complications from uncontrolled acid secretion. STUDY: Over the last 18 years, patients with gastric acid hypersecretory disorders have been followed prospectively with gastric acid analysis and endoscopy titrating oral lansoprazole and evaluating for complications. Protocol driven charges were calculated using the most recent information available. RESULTS: After 1 year of treatment optimization, 19 of 67 patients had 43 relapses, (once only in 10 patients). Risk markers for relapse included: (1) antrectomy, 67% relapsed versus 21% in unoperated patients; (2) basal acid output >5 mmol/h (risk=5.17); and (3) poor compliance. On treatment, 79% of 58 intact patients (excluding antrectomy) were lesion-free; 11% had only 1 relapse. Thus 90% were well managed with optimized lansoprazole alone. Protocol driven charges exceeded $25,000 the first year and $7000 annually thereafter. CONCLUSIONS: Relapse is infrequent and generally mild with acid secreting status closely monitored. The ideal strategy to balance costs and testing awaits further study.

EUS versus surgical cyst-gastrostomy for management of pancreatic pseudocysts.

BACKGROUND: Although EUS-guided cyst-gastrostomy is increasingly being performed, there are no studies that compare the clinical outcomes and cost-effectiveness with surgical cyst-gastrostomy. OBJECTIVES: To compare the clinical outcomes of EUS-guided cyst-gastrostomy with surgical cyst-gastrostomy for the management of patients with uncomplicated pancreatic pseudocysts and to perform a cost analysis of each treatment modality. DESIGN: A retrospective case-controlled study. SETTING: A tertiary-referral center. PATIENTS: Consecutive patients with uncomplicated pancreatic pseudocysts managed by surgical and EUS-guided cyst-gastrostomy. METHODS: An independent observer blinded to all clinic outcomes matched each patient who underwent a surgical cyst-gastrostomy with 2 patients who underwent an EUS-guided cyst-gastrostomy for age, etiology of pancreatitis, and the size of the pseudocyst. MAIN OUTCOME MEASUREMENTS: Rates of treatment success, complications, and reinterventions; length of postprocedure hospital stay; and cost associated with each treatment modality. RESULTS: Ten patients (6 men; mean age 42.3 years, range 22-65 years) who underwent surgical cyst-gastrostomy were matched with 20 patients who underwent an EUS-guided cyst-gastrostomy. There were no significant differences in demographics, major comorbidities, and clinical characteristics between both cohorts. Although there were no significant differences in rates of treatment success (100% vs 95%, P = .36), procedural complications (none in either cohort), or reinterventions (10% vs 0%, P = .13) between surgery versus an EUS-guided cyst-gastrostomy, the mean length of a postprocedure hospital stay for an EUS-guided cyst-gastrostomy was significantly shorter than for surgical cyst-gastrostomy (2.65 vs 6.5 days, P = .008). The average direct cost per case for EUS-guided cyst-gastrostomy was significantly less when compared with surgical cyst-gastrostomy ($9077 vs $14,815, P = .01), which corresponded to a cost savings of $5738 per patient. LIMITATIONS: Retrospective, nonrandomized design; patients with pancreatic abscess or necrosis were not evaluated; a limited sample size and a short duration of follow-up. CONCLUSIONS: EUS-guided cyst-gastrostomy should be considered as a first-line treatment approach for patients with uncomplicated pancreatic pseudocysts, because the procedure is cost saving and is associated with a shorter length of a postprocedure hospital stay when compared with surgical cyst-gastrostomy. There was no significant difference in clinical outcomes between both treatment modalities.

Economical and clinical outcomes of alternative treatment strategies in the management of common bile duct stones in the elderly: wait and see or surgery?

BACKGROUND: Common bile duct stones (CBDS) are especially prevalent in the elderly population. Although the standard of care for stone removal is endoscopic retrograde cholangiography with sphincterotomy (ERC-S), the clinician's decision to refer a patient for cholecystectomy after ERC-S depends on several factors including potential for future biliary symptoms and complications, morbidity and mortality related to cholecystectomy, and costs associated with referral for cholecystectomy versus conservative approach. Using decision analysis, we explored the economic implications of cholecystectomy versus expectant management following ERC-S in elderly patients with CBDS. MATERIALS AND METHOD: A decision tree was constructed with DATA 3.5 (Williamstown, MA) to estimate the costs and outcomes associated with two treatment strategies following ERC-S for CBDS in patients age 60 yr and older: (1) elective cholecystectomy, and (2) expectant management. Probabilities for potential complications and outcomes were derived from the medical literature and cost reflected Medicare reimbursement rates at our institution. The time horizon of the analysis was 2 yr. RESULTS: Elective cholecystectomy was associated with total costs of 5,259 dollars with 94.3% of the cohort alive (1.886 life-years) at 2 yr, whereas expectant management was associated with total costs of 1,173 dollars with 94.7% of the cohort alive (1.894 life-years). The results were sensitive to the probability of recurrent biliary symptoms in patients treated conservatively. Compared to elective cholecystectomy, expectant management became less effective and more expensive at a yearly probability of recurrent symptoms greater than 40% and 90%, respectively. CONCLUSIONS: In patients aged 60 and older, expectant management after ERC-S for CBDS is a reasonable approach, but the economic attractiveness of this strategy is highly dependent on the probability of recurrent symptoms.

Re-examination of the cost-effectiveness of surgical versus medical therapy in patients with gastroesophageal reflux disease: the value of long-term data collection.

OBJECTIVES: For patients with reflux esophagitis, long-term therapeutic options include proton pump inhibitor (PPI) therapy and/or antireflux surgery. An earlier cost-effectiveness analysis concluded that at 5 yr, medical therapy was less expensive but similarly effective to fundoplication, but the results were sensitive to estimates on quality of life and long-term medication usage, which were derived from "expert opinion." Recently, data from randomized controlled trials addressing these variables have become available. We have incorporated these new data into a revised Markov model to examine the cost-effectiveness of surgical versus medical therapy in patients with severe reflux esophagitis. METHODS: A Markov simulation model was constructed using specialized software (DATA PRO 4.0, Williamstown, MA). Total expected costs and quality-adjusted life-years were calculated for long-term medical therapy and for laparoscopic Nissen fundoplication. Probabilities were obtained from the medical literature using Medline. Procedural and hospitalization costs used were the average Medicare reimbursements at our institution. Medication costs were the average wholesale price. The analysis was extended over a 10-yr time horizon at a discount rate of 3%. RESULTS: The discounted analysis shows that medical therapy is associated with total costs of 8,798 dollars and 4.59 quality-adjusted life-years, whereas the surgical strategy is more expensive (10,475 dollars) and less effective (4.55 quality-adjusted life-years). The results were robust to most one-way sensitivity analyses. CONCLUSIONS: Long-term medical therapy with proton pump inhibitors is the preferred strategy for patients with gastroesophageal reflux disease and severe esophagitis. Our study highlights the importance of using primary, patient-derived data rather than expert opinion.

Biliary stents in malignant obstructive jaundice due to pancreatic carcinoma: a cost-effectiveness analysis.

OBJECTIVES: Obstructive jaundice frequently complicates pancreatic carcinoma and is associated with complications such as malabsorption, coagulopathy, progressive hepatocellular dysfunction, and cholangitis in addition to disabling pruritus, which greatly interferes with terminal patients' quality of life. Endoscopic placement of biliary stents decreases the risk of these complications and is considered the procedure of choice for palliation for patients with unresectable tumors. We used decision analysis with Markov modeling to compare the cost-effectivenesses of plastic stents and metal stents in patients with unresectable pancreatic carcinoma. METHODS: A model of the natural history of unresectable pancreatic carcinoma was constructed using probabilities derived from the literature. Cost estimates were obtained from Medicare reimbursement rates and supplemented by the literature. Two strategies were evaluated: 1) initial endoscopic plastic stent placement and 2) initial endoscopic metal stent placement. We compared total costs and performed cost-effectiveness analysis in these strategies. The outcome measures were quality-adjusted life months. Sensitivity analyses were performed on selected variables. RESULTS: Our baseline analysis showed that initial plastic stent placement was associated with a total cost of $13,879/patient and 1.799 quality-adjusted life months. Initial placement of a metal stent cost $13,466/patient and conferred 1.832 quality-adjusted life months. Among the variables examined, expected patient survival was demonstrated by sensitivity analyses to have the most influence on the results of the model. CONCLUSION: Initial endoscopic placement of a metal stent is a cost-saving strategy compared to initial plastic stent placement, particularly in patients expected to survive longer than 6 months.