Clinical outcomes of peroral endoscopic myotomy with and without septotomy for management of epiphrenic diverticula: an international multicenter experience.

BACKGROUND AND AIMS: There are few data favoring the need for septotomy at the time of peroral endoscopic myotomy (POEM) or if POEM alone is sufficient. Our aim was to compare POEM outcomes with and without septotomy (POEM+S or POEM-S) in patients with symptomatic epiphrenic diverticula (ED) and an underlying motility disorder. METHODS: This was an international, multicenter retrospective study involving 21 centers between January 2014 and January 2023. Patients with ED and an underlying motility disorder who underwent POEM were included. The primary outcome was clinical success (Eckardt score [ES] ≤3 or a 1-point drop in ES for patients with baseline ES <3) without the need for repeat surgical/endoscopic interventions during follow-up. RESULTS: A total of 85 patients (mean age, 64.29 ± 17.1 years; 32 [37.6%] female) with ED and underlying motility disorder underwent POEM+S (n = 47) or POEM-S (n = 38). Patients in the POEM+S group had a significantly higher mean pre-POEM ES (7.3 ± 2.1 vs 5.8 ± 2; P = .002). The most common indication for POEM was achalasia (51% in the POEM+S cohort and 51.8% in the POEM-S cohort; P = .7). A posterior approach was favored in the POEM+S group (76.6% vs 52.6%; P = .02). A similar rate of technical success was seen in both groups (97.9% vs 100%; P = .1). The rate of adverse events was similar between the 2 cohorts (4.2% vs 8.1%; P = .6). The median length of hospital stay after POEM-S was significantly longer compared with POEM+S (2 days [interquartile range (IQR), 1-4 days] vs 1 day [IQR, 1-2 days]; P = .005). Clinical success was equivalent between the 2 groups (83% vs 86.8%; P = .6) at a median follow-up duration of 8 months (IQR, 3-19 months). CONCLUSIONS: In patients with ED and an underlying motility disorder, both POEM+S and POEM-S are equally safe and effective, with similar procedure duration and a low recurrence rate at short-term follow-up. Future comparative prospective studies with long-term follow-up are required to validate these findings.

Modern insights into the pathophysiology and treatment of pseudoachalasia.

BACKGROUND: Secondary achalasia or pseudoachalasia is a clinical presentation undistinguishable from achalasia in terms of symptoms, manometric, and radiographic findings, but associated with different and identifiable underlying causes. METHODS: A literature review was conducted on the PubMed database restricting results to the English language. Key terms used were "achalasia-like" with 63 results, "secondary achalasia" with 69 results, and "pseudoachalasia" with 141 results. References of the retrieved papers were also manually reviewed. RESULTS: Etiology, diagnosis, and treatment were reviewed. CONCLUSIONS: Pseudoachalasia is a rare disease. Most available evidence regarding this condition is based on case reports or small retrospective series. There are different causes but all culminating in outflow obstruction. Clinical presentation and image and functional tests overlap with primary achalasia or are inaccurate, thus the identification of secondary achalasia can be delayed. Inadequate diagnosis leads to futile therapies and could worsen prognosis, especially in neoplastic disease. Routine screening is not justifiable; good clinical judgment still remains the best tool. Therapy should be aimed at etiology. Even though Heller's myotomy brings the best results in non-malignant cases, good clinical judgment still remains the best tool as well.

25 Years of the GERD-HRQL symptom severity instrument: an assessment of published applications.

BACKGROUND: The GERD-HRQL symptom severity instrument was developed and published 25 years ago. This seems like an apropos time to review how the instrument has been used in the "real-world." METHODS: Google Scholar, PubMed, and Web of Science websites search was done using the keywords "GERD-HRQL" or its author, "Velanovich." Once articles were identified, the following information was obtained from each article: first author name, country of origin, journal published, year of publications, type of study design, subject of study, category of study, disease type studied, purpose of the study, how the GERD-HRQL scores were reported, how the GERD-HRQL scores were statistically reported, and results of the study. The total and change of scores were analyzed for descriptive statistics based on disease process studied and intervention studied. RESULTS: A total of 767 articles by 562 different first authors were identified in 193 different journals from 53 different countries of study origin. After a period of steady usages, the number of publication employing the GERD-HRQL has rapidly increase over the last 5 years. There have been 8 validated translations into other languages, although there appears to be numerous, non-validated ad hoc translations. Most commonly used or studied: observational cohort study design, surgical treatment study category, GERD disease process, treatment effect study purpose, total GERD-HRQL scores reported as means or medians. However, there were a wide variety of other study designs, study categories, disease processes, and study purposes. In general, GERD and laryngopharyngeal reflux had the high pre-treatment scores (i.e., more severe symptoms), and surgical and endoscopic interventions the lowest post-treatment score (i.e., least severe symptoms) with the largest change in score (i.e., treatment impact. CONCLUSIONS: The GERD-HRQL has proven to be a reliable, responsive and versatile symptom severity instrument for studies involving GERD as a subject.

Novel "starburst" mesh configuration for paraesophageal and recurrent hiatal hernia repair: comparison with keyhole mesh configuration.

BACKGROUND: Controversy exists over the use of mesh, its type and configuration in repair of hiatal hernia. We have used biological mesh for large or recurrent hiatal hernias. We have developed a mesh configuration to better enhance the tensile strength of the hiatus by folding the mesh over the edge of the hiatus-entitled the "starburst" configuration. We report our experience with the starburst configuration, comparing it to our results with the keyhole configuration. METHODS: Medical records of all patients undergoing either the keyhole or starburst mesh configuration hiatal hernia repair were reviewed between 2017 and 2021. Data gathered included age, sex, type of hernia (sliding, paraesophageal, or recurrent), fundoplication type (none, Nissen, Toupet, Dor, Collis-Nissen, Collis-Toupet, or magnetic sphincter augmentation [MSA]), 30-day complications, and long-term outcomes (hiatal hernia recurrence, reflux-symptom recurrence, dysphagia, dilations, reoperations). RESULTS: From 7/2017 to 8/2019, 51 cases using the keyhole mesh were completed. Sliding hiatal hernia comprised 4%, paraesophageal hernia (PEH) 64% and recurrent hiatal hernia (RHH) 34% of cases. Distribution of fundoplication type: 2% none, 41% Nissen, 41% Toupet, 8% Dor, 2% Collis-Nissen, and 6% Collis-Toupet. 30-day complication rate 31%. Long-term outcomes: recurrent hiatal hernia 16%, dysphagia 12%, dysphagia requiring dilation(s) 10%, recurrent GERD symptoms 4%, and reoperation 14%. From 10/2020 to 8/2021, 58 cases using the starburst configuration were completed. PEH comprised 60% and RHH 40%. Distribution of fundoplication type: 10% none, 40% Nissen, 43% Toupet, 5% MSA, 2% Collis-Toupet. 30-day complication rate 16%. Long-term outcomes: recurrent hiatal hernia 19%, dysphagia 14%, dilations 5%, recurrent GERD symptoms 9%, and reoperations 3%. CONCLUSION: The starburst mesh configuration compares favorably with the keyhole configuration with respect to postoperative dysphagia, need for esophageal dilation, and GERD symptom recurrence, with similar recurrence rates. We are continuing to further refine this technique and study the long-term outcomes.

Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD).

BACKGROUND: Gastroesophageal reflux disease (GERD) is one of the most common diseases in North America and globally. The aim of this guideline is to provide evidence-based recommendations regarding the most utilized and available endoscopic and surgical treatments for GERD. METHODS: Systematic literature reviews were conducted for 4 key questions regarding the surgical and endoscopic treatments for GERD in adults: preoperative evaluation, endoscopic vs surgical or medical treatment, complete vs partial fundoplication, and treatment for obesity (body mass index [BMI] ≥ 35 kg/m2) and concomitant GERD. Evidence-based recommendations were formulated using the GRADE methodology by subject experts. Recommendations for future research were also proposed. RESULTS: The consensus provided 13 recommendations. Through the development of these evidence-based recommendations, an algorithm was proposed for aid in the treatment of GERD. Patients with typical symptoms should undergo upper endoscopy, manometry, and pH-testing; additional testing may be required for patients with atypical or extra-esophageal symptoms. Patients with normal or abnormal findings on manometry should consider undergoing partial fundoplication. Magnetic sphincter augmentation or fundoplication are appropriate surgical procedures for adults with GERD. For patients who wish to avoid surgery, the Stretta procedure and transoral incisionless fundoplication (TIF 2.0) were found to have better outcomes than proton pump inhibitors alone. Patients with concomitant obesity were recommended to undergo either gastric bypass or fundoplication, although patients with severe comorbid disease or BMI > 50 should undergo Roux-en-Y gastric bypass for the additional benefits that follow weight loss. CONCLUSION: Using the recommendations an algorithm was developed by this panel, so that physicians may better counsel their patients with GERD. There are certain patient factors that have been excluded from included studies/trials, and so these recommendations should not replace surgeon-patient decision making. Engaging in the identified research areas may improve future care for GERD patients.

The Accumulating Deficits Model for Postoperative Mortality and Readmissions: Comparison of Four Methods Over Multiple Calendar Year Cohorts.

OBJECTIVE: To assess 4 measures of the accumulating deficits model of frailty for postoperative mortality and readmissions including their stability over time. BACKGROUND: Frailty has been assessed by multiple methods. It is unclear whether variation in how frailty is measured is important and would be stable over time. METHODS: Rockwood's 57-item frailty index was mapped onto 14,568 ICD9 diagnosis codes from Healthcare Cost and Utilization Project State Inpatient Database for the state of Florida (HCUP-SID-FL) for calendar years 2011 to 2015, inclusive, with 962 ICD9 codes matching onto 42 items. This became the modified frailty index (mFI) used. Three measures of the mFI were differentiated: the number of admission diagnoses, number of chronic conditions upon admission, and number of increased deficits accumulated during the admission. The Charlson Co-Morbidity Index was a fourth measure of frailty. The mFI of patients who survived or died and were readmitted or not were compared. RESULTS: Across all years, 4,796,006 patient observations were compared to the number of diagnoses matched on the 42 items of the mFI. The median mFI scores for each method was statistically significantly higher for patients who died compared those that survived and for patients readmitted compared to patients not readmitted for all years. There was little-to-no variation in the year to year median mFI scores. CONCLUSIONS: The 4 methods of calculating frailty performed similarly and were stable. The actual method of determining the accumulated deficits may not be as important as enumerating their number.

Predicting Elective Surgical Patient Outcome Destination Based on the Preoperative Modified Frailty Index and Laboratory Values.

INTRODUCTION: To determine the accuracy of preoperative modified frailty index (mFI) with or without laboratory values (mFI-labs or labs-continuous) in predicting postoperative discharge destination. Discharge destination is important to providers and patients. The ability to accurately predict discharge destination preoperatively can improve hospital resource utilization and help set patient and family expectations. METHODS: Cohort analysis of the 2018 American College of Surgeon National Surgical Quality Improvement Project (ACS-NSQIP) Participant Use File of patients undergoing operations with complete data point sets: age, sex, operation work relative-value units; mFI-clinical based on 12 clinical findings, mFI-labs based on seven laboratory values. The nine hierarchical destinations: home, home with assistance, multi-level community, unskilled-care facility, rehabilitation facility, skilled-nursing facility, acute care hospital, hospice, or death, from best to worst outcome. Data were analyzed using univariate analysis, multiple logistic regression and supervised learning artificial neural networks. RESULTS: Univariate and multivariate in general showed that patients with higher mFI-clinical and mFI-lab scores, as well as older age and more complex operations were more likely to be discharged to facilities other than home. However, these statistical techniques could not predict the exact destination. An artificial neural network analysis demonstrated perfect location prediction in 64.9% of cases and within one level of prefect prediction is 87.4%. CONCLUSIONS: Using a limited number of preoperative factors, combining the mFI-clinical with laboratory values significantly improves the destination prediction performance significantly better than using the values separately. Preoperative knowledge of the likely discharge destination can benefit postoperative care planning and delivery.

Infectious outcomes after splenectomy for trauma, splenectomy for disease and splenectomy with distal pancreatectomy.

INTRODUCTION: The spleen provides a unique immune function in its production of opsins directed against encapsulated bacteria. Splenectomy, therefore, increases the risk of infections in patients as well as post-operative complications. This study aims to assess the risk of post-operative complications within 5 years of splenectomy by indication for splenectomy: trauma, disease, or in association with a distal pancreatectomy for pancreatic disease. The relationship between vaccination and infectious outcomes was also investigated. METHODS: This study is a review of splenectomy cases between June 2005 and June 2015 at a single institution. Infection, splenectomy indication, and vaccination history were identified from electronic medical records and lab test confirmations. Data was analyzed using Student's t test for continuous variables, the Mann-Whitney U test for ordinal variables, and a Chi-square/Fisher exact test for categorical variables. RESULTS: A total of 106 splenectomy patients were included: 35 traumatic (74% male) and 71 non-traumatic causes (42% male) with no significant difference in age. There were no statistical differences in complications during splenectomy and vaccination administration between the splenectomy indication groups: trauma, disease, and with distal pancreatectomy. There was a statistically significant higher infection rate within 5 years post-splenectomy in the non-traumatic vs traumatic group (42% vs 14.0%, p = 0.0040) with majority gastrointestinal (7/38) and respiratory (5/38) and surgical wound infections (3/38) observed in non-traumatic versus traumatic, respectively. CONCLUSION: Results from data analysis show a statistically significant difference in rates of infection within 5 years post-operatively between traumatic versus non-traumatic indications for splenectomies, with the non-traumatic group experiencing a higher rate of infectious outcomes. The non-traumatic group included patients with disease and distal pancreatectomy indications. This suggests that patients who have non-traumatic causes may be at a higher risk of developing infections following splenectomy procedure. Additionally, vaccinations did not appear to have a protective effect.

Management of patients after failed peroral endoscopic myotomy: a multicenter study.

BACKGROUND: Although peroral endoscopic myotomy (POEM) is highly effective for the management of achalasia, clinical failures may occur. The optimal management of patients who fail POEM is not well known. This study aimed to compare the outcomes of different management strategies in patients who had failed POEM. METHODS: This was an international multicenter retrospective study at 16 tertiary centers between January 2012 and November 2019. All patients who underwent POEM and experienced persistent or recurrent symptoms (Eckardt score > 3) were included. The primary outcome was to compare the rates of clinical success (Eckardt score ≤ 3) between different management strategies. RESULTS : 99 patients (50 men [50.5 %]; mean age 51.4 [standard deviation (SD) 16.2]) experienced clinical failure during the study period, with a mean (SD) Eckardt score of 5.4 (0.3). A total of 29 patients (32.2 %) were managed conservatively and 70 (71 %) underwent retreatment (repeat POEM 33 [33 %], pneumatic dilation 30 [30 %], and laparoscopic Heller myotomy (LHM) 7 [7.1 %]). During a median follow-up of 10 (interquartile range 3 - 20) months, clinical success was highest in patients who underwent repeat POEM (25 /33 [76 %]; mean [SD] Eckardt score 2.1 [2.1]), followed by pneumatic dilation (18/30 [60 %]; Eckardt score 2.8 [2.3]), and LHM (2/7 [29 %]; Eckardt score 4 [1.8]; P = 0.12). A total of 11 patients in the conservative group (37.9 %; mean Eckardt score 4 [1.8]) achieved clinical success. CONCLUSION : This study comprehensively assessed an international cohort of patients who underwent management of failed POEM. Repeat POEM and pneumatic dilation achieved acceptable clinical success, with excellent safety profiles.

Discordance between high-resolution manometry, esophagoscopy and contrast esophagogram in determining landmarks for per-oral endoscopic myotomy in spastic esophageal disorders: a word of caution.

BACKGROUND: Myotomy length for per-oral endoscopic myotomy (POEM) is standardized for type I and II achalasia. However, for type III achalasia, jackhammer esophagus, diffuse esophageal spasms and esophagogastric junction outflow obstruction, there is no standard. Determining myotomy length based on the high-pressure zone found during high-resolution manometry (HRM) and spastic length found during esophagography may be used to determine adequate myotomy length without excess muscle destruction. METHODS: The records of patients who have undergone POEM procedures at our institution had the following data gleaned: age, sex, esophageal spastic diagnosis, length of high-pressure zone and lower esophageal sphincter (LES) position by HRM, length of spastic esophagus by esophagography, position of the z-line by esophagoscopy and length of myotomy performed. Outcomes were assessed based on patient symptomatic improvement and need for re-intervention. RESULTS: 71 patients were evaluated for POEM, with 67 completing POEM. There was an average difference in LES position by HRM and z-line position by esophagoscopy of 3.9 ± 3.0 cm. There was an average difference in high-pressure zone by HRM and spastic length by esophagography of 4.9 ± 3.2 cm. Overall, with a median of 20 months follow-up, 74% achieved long-term symptomatic improvement, with 17 patients requiring re-intervention. CONCLUSIONS: Discordance among HRM, esophagography and esophagoscopy can be significant. Caution should be employed with using these methods to determine myotomy length in POEM.

Accuracy of Achalasia Quality of Life and Eckardt scores for assessment of clinical improvement post treatment for achalasia.

Achalasia Quality of Life (ASQ) and Eckardt scores are two patient-reported instruments widely used to assess symptom severity in achalasia patients. ASQ is validated and reliable. Although Eckardt is commonly used, it has not been rigorously assessed for validity or reliability. This study aims to evaluate (i) the accuracy of Eckardt and ASQ for assessing improvement post-treatment (predictive validity), (ii) accuracy of Eckardt and ASQ for assessing improvement post-treatment with pneumatic dilatation (PD) versus surgical myotomy (predictive validity), and (iii) convergent validity of Eckardt and ASQ tools. Patients with achalasia treated between 2011 and 2018 were eligible. Both instruments were administered by telephone. Treatment failure was determined by the review of medical records by two clinicians. The predictive ability of ASQ and Eckardt instruments in identifying treatment successes and failures was determined using receiver operating characteristics analysis and summarized as area under the curve (AUC). A total of 106 patients met inclusion criteria with 39 PD, 51 Heller myotomy, and 16 per-oral endoscopic myotomy. A review of medical records and esophageal testing revealed 13 failures (12%). AUC for Eckardt was 0.96 (95% confidence interval [CI] 0.87-0.99] and ASQ 0.97 (95% CI 0.92-0.99). The Eckardt cutoff 4, and ASQ, cutoff 15, were 94% and 87% accurate in identifying treatment successes versus failures, respectively. The correlation coefficient between the two tools was 0.85. In conclusions, (i) ASQ and Eckardt scores are valid and reliable tools to assess symptom severity in achalasia patients, (ii) both instruments accurately classify treatment successes versus failures, and (iii) the choice of tool should be informed by the physicians and patients' values and preferences and repeat physiologic testing may be reserved for treatment failures with either instrument and patients classified, as treatment successes may be spared routine physiologic testing in the long term.

Heller Myotomy for Epiphrenic Diverticula Compared to Nondiverticula Esophageal Motility Disorders, A Single Institution Experience and Appraisal of Patient Characteristics, High-Resolution Manometry and Outcomes.

PURPOSE: The purpose of this study was to compare demographics, symptoms, prior interventions, operation, and outcomes of patients who underwent Heller myotomy for esophageal motility disorders and epiphrenic diverticulectomy with Heller myotomy. METHODS: We identified all patients who underwent Heller myotomy for esophageal motility disorders with and without esophageal diverticulectomy over an 80-month period. Primary data points included patient demographics, presenting symptoms, prior intervention, high-resolution manometry, surgery performed with rate of laparoscopic, conversion to open, and open procedures; postoperative complications, and symptom resolution. RESULTS: Over the study period, 308 Heller esophagomyotomy operations were performed on 301 patients. Of these, 277 cases were without epiphrenic diverticula and 31 included diverticula. One patient with an asymptomatic epiphrenic diverticulum did not undergo surgery was included, for a total of 32 diverticula patients. Six patients in the non-diverticula group and 1 in the diverticula group required a second operation for recurrent symptoms or residual diverticulum. The diverticula group was significantly older, had different manometry findings, required more open operations, and had longer length of stay. The diverticula group had a lower frequency of patients with prior interventions, but similar postoperative leaks, higher overall postoperative complications, and no difference in reported symptomatic improvement. CONCLUSIONS: Esophageal diverticula patients have a unique profile compare to patients with non-diverticula motility disorders. Operations are more complex, with increased complication rate and a longer length of stay. In spite of this, there is no statistically significant difference in symptomatic outcomes between the groups.

Efficacy of Laparoscopic Nissen Fundoplication vs Transoral Incisionless Fundoplication or Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease: A Systematic Review and Network Meta-analysis.

BACKGROUND & AIMS: The effects of transoral incisionless fundoplication (TIF) and laparoscopic Nissen fundoplication (LNF) have been compared with those of proton pump inhibitors (PPIs) or a sham procedure in patients with gastroesophageal reflux disease (GERD), but there has been no direct comparison of TIF vs LNF. We performed a systematic review and network meta-analysis of randomized controlled trials to compare the relative efficacies of TIF vs LNF in patients with GERD. METHODS: We searched publication databases and conference abstracts through May 10, 2017 for randomized controlled trials that compared the efficacy of TIF or LNF with that of a sham procedure or PPIs in patients with GERD. We performed a network meta-analysis using Bayesian methods under random-effects multiple treatment comparisons. We assessed ranking probability by surface under the cumulative ranking curve. RESULTS: Our search identified 7 trials comprising 1128 patients. Surface under the cumulative ranking curve ranking indicated TIF had highest probability of increasing patients' health-related quality of life (0.96), followed by LNF (0.66), a sham procedure (0.35), and PPIs (0.042). LNF had the highest probability of increasing percent time at pH <4 (0.99), followed by PPIs (0.64), TIF (0.32), and the sham procedure (0.05). LNF also had the highest probability of increasing LES pressure (0.78), followed by TIF (0.72) and PPIs (0.01). Patients who underwent the sham procedure had the highest probability for persistent esophagitis (0.74), followed by those receiving TIF (0.69), LNF (0.38), and PPIs (0.19). Meta-regression showed a shorter follow-up time as a significant confounder for the outcome of health-related quality of life in studies of TIF. CONCLUSIONS: In a systematic review and network meta-analysis of trials of patients with GERD, we found LNF to have the greatest ability to improve physiologic parameters of GERD, including increased LES pressure and decreased percent time pH <4. Although TIF produced the largest increase in health-related quality of life, this could be due to the shorter follow-up time of patients treated with TIF vs LNF or PPIs. TIF is a minimally invasive endoscopic procedure, yet based on evaluation of benefits vs risks, we do not recommend it as a long-term alternative to PPI or LNF treatment of GERD.

How to choose among fundoplication, magnetic sphincter augmentation or transoral incisionless fundoplication.

PURPOSE OF REVIEW: To examine current trends and research in nonmedical approaches to the treatment of gastroesophageal reflux disease (GERD). RECENT FINDINGS: Long-term studies of GERD patients treated with transoral incisionless fundoplication (TIF) have found that a large portion of patients resume proton pump inhibitor therapy. In patients with uncomplicated GERD, magnetic sphincter augmentation (MSA) shows excellent short-term results in both patient satisfaction and physiologic measures of GERD, with fewer postoperative side-effects than fundoplication, although dysphagia can be problematic. SUMMARY: Fundoplication remains the standard of care for patients with GERD complicated by hiatal hernias more than 2 cm, Barrett's esophagus and/or grade C and D erosive esophagitis. For the patient with uncomplicated GERD, MSA appears to be a viable alternative that has greater technical standardization and fewer postoperative side-effects than fundoplication. TIF remains an option for patients with refractory GERD who refuse surgical intervention.

Minor psychiatric disorders and objective diagnosis of gastroesophageal reflux disease.

BACKGROUND: Symptoms may be unreliable to diagnose gastroesophageal reflux disease (GERD) in patients with minor psychiatric disorders (MPD). This study aims to evaluate the influence of MPD in the diagnosis of GERD. METHODS: We prospectively studied 245 patients (based on a sample size calculation) with suspected GERD. All patients underwent manometry and pH monitoring and MPD evaluation based on the Hospital Anxiety and Depression Scale (HADS). RESULTS: Based on the results of the pH monitoring, patients were classified as GERD + (n = 136, 55% of the total, mean age 46 years, 47% females) or GERD - (n = 109, 45% of the total, mean age 43 years, 60% females). The mean HADS score for GERD + and GERD - for anxiety was 7.8 and 8.5, respectively (p = 0.8) and for depression was 5.4 and 6.1, respectively (p = 0.1). DeMeester score (DS) did not correlate with total HADS score (p = 0.08) or depression domain (p = 0.9) but there was a negative correlation between DS and anxiety level (p < 0.001). A significant threshold accuracy value for HADS to diagnose GERD was not found on receiver operating characteristics curve analysis. CONCLUSION: Almost half of the patients evaluated for GERD did not have the disease on objective evaluation. GERD + and GERD - patients had similar levels of MPD. However, the amount of reflux correlated negatively with the severity of anxiety. Symptoms and HADS cannot accurately diagnose or exclude GERD. pH monitoring should be more liberally used especially in patients with high levels of anxiety.

A Prospective Randomized Multicenter Trial of Distal Pancreatectomy With and Without Routine Intraperitoneal Drainage.

OBJECTIVE: The objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications. BACKGROUND: The use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported. METHODS: Patients undergoing DP for all causes at 14 high-volume pancreas centers were preoperatively randomized to placement of a drain or no drain. Complications and their severity were tracked for 60 days and mortality for 90 days. The study was powered to detect a 15% positive or negative difference in the rate of grade 2 or higher grade complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy. RESULTS: A total of 344 patients underwent DP with (N = 174) and without (N = 170) the use of intraperitoneal drainage. There were no differences between cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, or operative technique. There was no difference in the rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004). There was no difference in the frequency of postoperative imaging, percutaneous drain placement, reoperation, readmission, or quality of life scores. CONCLUSIONS: This prospective randomized multicenter trial provides evidence that clinical outcomes are comparable in DP with or without intraperitoneal drainage.

Health-related quality of life and physiological measurements in achalasia.

The diagnosis of achalasia is generally made based on patient symptoms, the appearance of the esophagus on endoscopy and barium esophagogram, and esophageal manometry. In addition, timed barium esophagography (TBE) can give useful information on the clearance of liquid barium over a 10 minute period and the passage of a barium tablet. What is unclear is how well these physiological measurements of esophageal function correlate with patient-perceived health-related quality of life. Our aim was to assess whether objective physiological measurements of high-resolution manometry (HRM) and TBE will correlate with quantitative achalasia-related health-related quality of life (HRQoL) measurements. Patients referred for possible surgical treatment of achalasia were assessed preoperatively in the following manner. A gastroenterologist and surgeon clinically evaluated all patients. In addition to history and physical examination, patients underwent further testing with TBE, upper gastrointestinal endoscopy, and HRM. The diagnosis of achalasia was based on HRM. Prior to surgical treatment, patients completed the 'Measure of Achalasia Disease Severity' (ADS) which is a validated instrument assessing the severity of achalasia-associated HRQoL. Hundred and twenty patients were included in this study. The mean ADS score was 24.9 ± 3.6. There was no statistically significant difference in score among the achalasia types: I, 24.0 ± 4.3; II, 25.4 ± 3.2; III, 24.3 ± 4.6. Using linear regression analysis, there was no statistically significant correlation between ADS scores and TBE column height or width at 1 and 5 minutes. There was no statistically significant difference between patients who could pass a 13 mm barium tablet (26.4 ± 3.4) and those who could not (24.9 ± 3.6). There was no statistically significant correlation between LES pressure and IRP with ADS scores. There is poor correlation between patient-perceived health-related quality of life and objective physiological measurements of achalasia. Therefore, the assessment of treatment outcomes of achalasia will need to require both an assessment of esophageal physiology as well as HRQoL.

Minimally invasive pancreatic resections: cost and value perspectives.

BACKGROUND: The number of minimally invasive pancreatic resections (MIPR) performed for benign or malignant disease, have increased in recent years. However, there is limited information regarding cost/value implications. METHODS: An international conference evaluating MIPR was held during the 12th Bi-Annual International Hepato-Pancreato-Biliary Association (IHPBA) World Congress in Sao Paulo, Brazil, on April 20th, 2016. This manuscript summarizes the presentations that reviewed current topics in cost and value as they pertain to MIPR. RESULTS: Compared to the open approach, MIPR's are associated with higher operative costs but lower postoperative costs. However, measurements of patient value (defined as improvement in both quantity and quality of life) and financial value (using incremental cost-effectiveness ratio) are required to determine the true value at societal level. CONCLUSION: Challenges remain as to how the potential benefits, both to the patient and the healthcare system as a whole, are measured. Research comparing MIPR versus other techniques for pancreatectomy will require appropriate and valid measurement tools, some of which are yet to be refined. Nonetheless, the experience to date would support the continued development of MIPR by experienced surgeons in high-volume pancreatic centers, married with appropriate review and recalibration.

Defining optimum treatment of patients with pancreatic adenocarcinoma using regret-based decision curve analysis.

OBJECTIVE: To use regret decision theory methodology to assess three treatment strategies in pancreatic adenocarcinoma. BACKGROUND: Pancreatic adenocarcinoma is uniformly fatal without operative intervention. Resection can prolong survival in some patients; however, it is associated with significant morbidity and mortality. Regret theory serves as a novel framework linking both rationality and intuition to determine the optimal course for physicians facing difficult decisions related to treatment. METHODS: We used the Cox proportional hazards model to predict survival of patients with pancreatic adenocarcinoma and generated a decision model using regret-based decision curve analysis, which integrates both the patient's prognosis and the physician's preferences expressed in terms of regret associated with a certain action. A physician's treatment preferences are indicated by a threshold probability, which is the probability of death/survival at which the physician is uncertain whether or not to perform surgery. The analysis modeled 3 possible choices: perform surgery on all patients; never perform surgery; and act according to the prediction model. RESULTS: The records of 156 consecutive patients with pancreatic adenocarcinoma were retrospectively evaluated by a single surgeon at a tertiary referral center. Significant independent predictors of overall survival included preoperative stage [P = 0.005; 95% confidence interval (CI), 1.19-2.27], vitality (P < 0.001; 95% CI, 0.96-0.98), daily physical function (P < 0.001; 95% CI, 0.97-0.99), and pathological stage (P < 0.001; 95% CI, 3.06-16.05). Compared with the "always aggressive" or "always passive" surgical treatment strategies, the survival model was associated with the least amount of regret for a wide range of threshold probabilities. CONCLUSIONS: Regret-based decision curve analysis provides a novel perspective for making treatment-related decisions by incorporating the decision maker's preferences expressed as his or her estimates of benefits and harms associated with the treatment considered.

A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage.

OBJECTIVE: To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy (PD) without the use of intraperitoneal drainage does not increase the frequency or severity of complications. BACKGROUND: Some surgeons have abandoned the use of drains placed during pancreas resection. METHODS: We randomized 137 patients to PD with (n = 68, drain group) and without (n = 69, no-drain group) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups. RESULTS: There were no differences between drain and no-drain cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, baseline quality of life, or operative technique. PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [1 (0-2) vs 2 (1-4), P = 0.029]; an increase in the number of patients who had at least 1 ≥grade 2 complication [35 (52%) vs 47 (68%), P = 0.047]; and a higher average complication severity [2 (0-2) vs 2 (1-3), P = 0.027]. PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis, intra-abdominal fluid collection, intra-abdominal abscess (10% vs 25%, P = 0.027), severe (≥grade 2) diarrhea, need for a postoperative percutaneous drain, and a prolonged length of stay. The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3% to 12% in the patients undergoing PD without intraperitoneal drainage. CONCLUSIONS: This study provides level 1 data, suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications.