Early safety of endoscopic sleeve gastroplasty in super obesity (body mass index > 50).

BACKGROUND: The prevalence of super obesity (body mass index [BMI] > 50) continues to rise. However, the adoption of bariatric surgery in this population remains very low. There are limited studies evaluating the utility of endoscopic sleeve gastroplasty (ESG) in super obesity. OBJECTIVES: The purpose of this study is to evaluate the short-term safety profile of ESG in patients with super obesity using data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database. SETTING: United States. METHODS: We retrospectively analyzed patients who underwent ESG and sleeve gastrectomy (SG) from 2016 to 2021. Patients with BMI >50 who underwent ESG were compared to ESG patients with BMI <50 and also SG patients with BMI >50. Primary outcomes included the incidence of severe adverse events (AEs), hospital readmission, reintervention, and reoperation within 30 days of the primary procedure. Secondary outcomes included procedure time, hospital length of stay, and total body weight loss at 30 days. RESULTS: There were no significant differences in AE, reoperations, hospital readmissions, or reinterventions for patients with super obesity undergoing ESG, compared to patients with BMI below 50. Mean total body weight loss was greater in patients with super obesity. There were no significant differences in AEs for patients with super obesity who underwent ESG versus SG, although ESG patients had more hospital readmissions, reinterventions, and reoperations. CONCLUSIONS: ESG may be performed safely, with comparable safety to SG, in patients with BMI as high as 70. However, further studies are needed to validate the feasibility and long-term efficacy prior to clinical implementation.

Survival benefit associated with screening of patients at elevated risk for pancreatic cancer.

BACKGROUND & OBJECTIVES: Screening for pancreatic cancer is recommended for individuals with a strong family history, certain genetic syndromes, or a neoplastic cyst of the pancreas. However, limited data supports a survival benefit attributable to screening these higher-risk individuals. METHODS: All patients enrolled in screening at a High-Risk Pancreatic Cancer Clinic (HRC) from July 2013 to June 2020 were identified from a prospectively maintained institutional database and compared to patients evaluated at a Surgical Oncology Clinic (SOC) at the same institution during the same period. Clinical outcomes of patients selected for surgical resection, particularly clinicopathologic stage and overall survival, were compared. RESULTS: Among 826 HRC patients followed for a median (IQR) of 2.3 (0.8-4.2) years, 128 were selected for surgical resection and compared to 402 SOC patients selected for resection. Overall survival was significantly longer among HRC patients (median survival: not reached vs. 2.6 years, p < 0.001). Among 31 HRC and 217 SOC patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC), the majority of HRC patients were diagnosed with stage 0 disease (carcinoma in situ), while the majority of SOC patients were diagnosed with stage II disease (p < 0.001). Overall survival after resection of invasive PDAC was also significantly longer among HRC patients compared to SOC patients (median survival 5.5 vs. 1.6 years, p = 0.002). CONCLUSION: Patients at increased risk for PDAC and followed with guideline-based screening exhibited downstaging of disease and improved survival from PDAC in comparison to patients who were not screened.

Comparative accuracy of four guidelines to predict high-grade dysplasia or malignancy in surgically resected pancreatic intraductal papillary mucinous neoplasms: Small nuances between guidelines lead to vastly different results.

Backgrounds/Aims: The guidelines regarding the management of intraductal papillary mucinous neoplasms (IPMNs) all have slightly different surgical indications for high-risk lesions. We aim to retrospectively compare the accuracy of four guidelines in recommending surgery for high-risk IPMNs, and assess the accuracy of elevated CA-19-9 levels and imaging characteristics of IPMNs considered high-risk in predicting malignancy or high-grade dysplasia (HGD). Methods: The final histopathological diagnosis of surgically resected high-risk IPMNs during 2013-2020 were compared to preoperative surgical indications, as enumerated in four guidelines: the 2015 American Gastroenterological Association (AGA), 2017 International Consensus, 2018 European Study Group, and 2018 American College of Gastroenterology (ACG). Surgery was considered "justified" if histopathology of the surgical specimen showed HGD/malignancy, or there was postoperative symptomatic improvement. Results: Surgery was postoperatively justified in 26/65 (40.0%) cases. All IPMNs with HGD/malignancy were detected by the 2018 ACG and the combined (absolute and relative criteria) 2018 European guidelines. The combined ("high-risk stigmata" and "worrisome features") 2017 International guideline missed 1/19 (5.3%) IPMNs with HGD/malignancy. The 2015 AGA guideline missed the most cases (11/19, 57.9%) of IPMNs with HGD/malignancy. We found the features most-associated with HGD/malignancy were pancreatic ductal dilation, and elevated CA-19-9 levels. Conclusions: Following the 2015 AGA guideline results in the highest rate of missed HGD/malignancy, but the lowest rate of operating on IPMNs without these features; meanwhile, the 2018 ACG and the combined (absolute and relative criteria) 2018 European guidelines result in more operations for IPMNs without HGD/malignancy, but the lowest rates of missed HGD/malignancy in IPMNs.

Endoscopic Management of Pain due to Chronic Pancreatitis.

Pain secondary to chronic pancreatitis is a poorly understood and complex phenomenon. Current endoscopic treatments target pancreatic duct decompression secondary to strictures, stones, or inflammatory and neoplastic masses. When there is refractory pain and other treatments have been unsuccessful, one can consider an endoscopic ultrasound-guided celiac plexus block. Data on the latter are underwhelming.

Increased rate of pancreatitis in gender diverse and transgender patients on hormone therapy: a case series study.

BACKGROUND: There is limited data on the incidence of gastrointestinal-specific pathology in gender non-conforming (GNC) populations. METHODS: Retrospective analysis of pancreatitis incidence rates in transgender and GNC persons exposed and not exposed to gender-affirming hormone therapy (GAHT). RESULTS: 7 of the 1333 patients on hormone therapy had an incidence of pancreatitis. 0 of the 615 patients with no history of GAHT use developed pancreatitis. Representing a 6.96 (95% CI 2.76 to 848.78) for the development of pancreatitis in patients with exposure to GAHT therapy. CONCLUSION: Clinicians working with GNC individuals should be aware of this possible association.

Associations between income and survival in cholangiocarcinoma: A comprehensive subtype-based analysis.

Backgrounds/Aims: Socioeconomic determinants of health are incompletely characterized in cholangiocarcinoma (CCA). We assessed how socioeconomic status influences initial treatment decisions and survival outcomes in patients with CCA, additionally performing multiple sub-analyses based on anatomic location of the primary tumor. Methods: Observational study using the 2018 submission of the Surveillance, Epidemiology, and End Results (SEER)-18 Database. In total, 5,476 patients from 2004-2015 with a CCA were separated based on median household income (MHI) into low income (< 25th percentile of MHI) and high income (> 25th percentile of MHI) groups. Seventy-three percent of patients had complete follow up data, and were included in survival analyses. Survival and treatment outcomes were calculated using R-studio. Results: When all cases of CCA were included, the high-income group was more likely than the low-income to receive surgery, chemotherapy, and local tumor destruction modalities. Initial treatment modality based on income differed significantly between tumor locations. Patients of lower income had higher overall and cancer-specific mortality at 2 and 5 years. Non-cancer mortality was similar between the groups. Survival differences identified in the overall cohort were maintained in the intrahepatic CCA subgroup. No differences between income groups were noted in cancer-specific or overall mortality for perihilar tumors, with variable differences in the distal cohort. Conclusions: Lower income was associated with higher rates of cancer-specific mortality and lower rates of surgical resection in CCA. There were significant differences in treatment selection and outcomes between intrahepatic, perihilar, and distal tumors. Population-based strategies aimed at identifying possible etiologies for these disparities are paramount to improving patient outcomes.

Evolution of interventional endoscopic ultrasound.

Endoscopic ultrasound (EUS) has become an indispensable modality for the assessment of the gastrointestinal tract and adjacent structures since its origin in the 1980s. Following the development of the linear echoendoscope, EUS has evolved from a purely diagnostic modality to a sophisticated tool for intervention, with numerous luminal, pancreaticobiliary, and hepatic applications. Broadly, these applications may be subdivided into three categories: transluminal drainage or access procedures, injection therapy, and EUS-guided liver interventions. Transluminal drainage or access procedures include management of pancreatic fluid collection, EUS-guided biliary drainage, EUS-guided bile duct drainage, EUS-guided pancreatic duct drainage, and enteral anastomosis formation. Injection therapies include therapeutic EUS-guided injections for management of malignancies accessible by EUS. EUS-guided liver applications include EUS-guided liver biopsy, EUS-guided portal pressure gradient measurement, and EUS-guided vascular therapies. In this review, we discuss the origins of each of these EUS applications, evolution of techniques leading to the current status, and future directions of EUS-guided interventional therapy.

AGA Clinical Practice Update on Interventional EUS for Vascular Investigation and Therapy: Commentary.

DESCRIPTION: The purpose of this AGA Institute Clinical Practice Update is to review the available evidence supporting and examine opportunities for future research in endoscopic ultrasound-guided vascular investigation and therapies. METHODS: This Clinical Practice Update was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors who are advanced endoscopists with expertise in endoscopic ultrasound-guided vascular investigation and therapy.

Socioeconomic Disparities Affect Outcomes in Early-Stage Esophageal Adenocarcinoma: A SEER Analysis.

BACKGROUND & AIMS: Socioeconomic determinants of health are understudied in early stage esophageal adenocarcinoma. We aimed to assess how socioeconomic status influences initial treatment decisions and survival outcomes in patients with T1a esophageal adenocarcinoma. METHODS: We performed an observational study using the 2018 submission of the Surveillance, Epidemiology, and End Results-18 database. A total of 1526 patients from 2004 to 2015 with a primary T1aN0M0 esophageal adenocarcinoma were subdivided into 3 socioeconomic tertiles based on their median household income. Endoscopic trends over time, rates of endoscopic and surgical treatment, 2- and 5-year overall survival, cancer-specific mortality, and non-cancer-specific mortality were calculated. Statistical analysis was performed using R-studio. RESULTS: Patients within the lowest median household income tertile ($20,000-$54,390) were associated with higher cancer-specific mortality at 2 years (P < .01) and 5 years (P < .02), and lower overall survival at 2 and 5 years (P < .01) compared with patients in higher income tertiles. Patients with a higher income had a decreased hazard ratio for cancer-specific mortality (hazard ratio, 0.66; 95% CI, 0.45-0.99) in a multivariate Cox proportional hazards regression model. Patients within the higher income tertile were more likely to receive endoscopic intervention (P < .001), which was associated with improved cancer-specific mortality compared with patients who received primary surgical intervention (P = .001). The South had lower rates of endoscopy compared with other regions. CONCLUSIONS: Lower median household income was associated with higher rates of cancer-specific mortality and lower rates of endoscopic resection in T1aN0M0 esophageal adenocarcinoma. Population-based strategies aimed at identifying and rectifying possible etiologies for these socioeconomic and geographic disparities are paramount to improving patient outcomes in early esophageal cancer.

Endoscopic Sleeve Gastroplasty: A Safe Bariatric Intervention for Class III Obesity (BMI > 40).

PURPOSE: Endoscopic sleeve gastroplasty (ESG) is primarily offered to patients with class I and II obesity (BMI 30-40), although there are no guidelines specifying applicability. There is little data comparing ESG to bariatric surgery in patients with class III obesity (BMI > 40). This study evaluates the short-term safety of ESG compared to sleeve gastrectomy (SG) and gastric bypass (RYGB) in patients with class III obesity. METHODS: We retrospectively analyzed over 500,000 patients who underwent ESG, SG, and RNYGB from 2016 to 2020 in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database. ESG patients were stratified by BMI to compare outcomes between class I and II versus class III obese patients. Class III obese patients who underwent ESG were also propensity matched to SG and RNYGB patients for matched comparisons. Primary outcomes included adverse events (AE), readmissions, re-operations, and re-interventions within 30 days. Secondary outcomes included procedure time, length of stay (LOS), and total body weight loss (%TBWL) at 30 days. RESULTS: Among ESG patients, those with BMI > 40 had no difference in AE, readmissions, or re-interventions versus patients with BMI 30-40 (p > 0.05), while achieving greater %TBWL at 30 days (p < 0.05). In comparison to surgery, ESG had similar AE to SG and less than RNYGB, while producing comparable %TBWL to SG and RNYGB at 30 days. CONCLUSIONS: The feasibility and safety of ESG in patients with class III obesity are comparable to patients with class I and II obesity. Additionally, the safety of ESG in patients with class III obesity is comparable to SG and safer than RYGB. Endoscopic sleeve gastroplasty: a safe bariatric intervention for class III obesity (BMI > 40).

ACG Clinical Guideline: Diagnosis and Management of Gastrointestinal Subepithelial Lesions.

Subepithelial lesions (SEL) of the GI tract represent a mix of benign and potentially malignant entities including tumors, cysts, or extraluminal structures causing extrinsic compression of the gastrointestinal wall. SEL can occur anywhere along the GI tract and are frequently incidental findings encountered during endoscopy or cross-sectional imaging. This clinical guideline of the American College of Gastroenterology was developed using the Grading of Recommendations Assessment, Development, and Evaluation process and is intended to suggest preferable approaches to a typical patient with a SEL based on the currently available published literature. Among the recommendations, we suggest endoscopic ultrasound (EUS) with tissue acquisition to improve diagnostic accuracy in the identification of solid nonlipomatous SEL and EUS fine-needle biopsy alone or EUS fine-needle aspiration with rapid on-site evaluation sampling of solid SEL. There is insufficient evidence to recommend surveillance vs resection of gastric gastrointestinal stromal tumors (GIST) <2 cm in size. Owing to their malignant potential, we suggest resection of gastric GIST >2 cm and all nongastric GIST. When exercising clinical judgment, particularly when statements are conditional suggestions and/or treatments pose significant risks, health-care providers should incorporate this guideline with patient-specific preferences, medical comorbidities, and overall health status to arrive at a patient-centered approach.

Comparison of endoscopic sleeve gastroplasty versus surgical sleeve gastrectomy: a Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database analysis.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an incisionless, transoral, restrictive bariatric procedure designed to imitate sleeve gastrectomy (SG). Comparative studies and large-scale population-based data are limited. Additionally, no studies have examined the impact of race on outcomes after ESG. This study aims to compare short-term outcomes of ESG with SG and evaluate racial effects on short-term outcomes after ESG. METHODS: We retrospectively analyzed over 600,000 patients in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database from 2016 to 2020. We compared occurrences of adverse events (AEs), readmissions, reoperations, and reinterventions within 30 days after procedures. Multivariate regression evaluated the impact of patient factors, including race, on AEs. RESULTS: A total of 6054 patients underwent ESG and 597,463 underwent SG. AEs were low after both procedures with no significant difference in major AEs (SG vs ESG: 1.1% vs 1.4%; P > .05). However, patients undergoing ESG had more readmissions (3.8% vs 2.6%), reoperations (1.4% vs .8%), and reinterventions (2.8% vs .7%) within 30 days (P < .05). Race was not significantly associated with AEs after ESG, with black race associated with a higher risk of AEs in SG. CONCLUSIONS: ESG demonstrates a comparable major AE rate with SG. Race did not impact short-term AEs after ESG. Further prospective studies long-term studies are needed to compare ESG with SG.

Impact of Proceduralist Specialty on Outcomes Following Endoscopic Sleeve Gastroplasty.

PURPOSE: Endoscopic sleeve gastroplasty (ESG) is a novel minimally invasive weight loss procedure designed to mimic gastric volume reduction of surgical sleeve gastrectomy. Currently, both bariatric surgeons and gastroenterologists perform ESG, and early reports suggest that ESG is safe and effective for weight loss. However, as gastroenterologists and bariatric surgeons have variations in training backgrounds, it is important to evaluate for potential differences in clinical outcomes. To date, there are no studies comparing the impact of proceduralist specialization on outcomes of ESG. This study aims to assess whether proceduralist specialization impacts short-term safety and efficacy after ESG. METHODS: We retrospectively analyzed over 6,000 patients who underwent ESG from 2016 to 2020 in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. ESG patients were stratified into two groups depending on the specialty of the physician performing the procedure, and propensity matched using baseline patient characteristics. We primarily compared adverse events (AE), readmissions, re-operations, and re-interventions within 30 days after procedure. Secondary outcomes included procedure time, length of stay (LOS), early weight loss, and emergency department (ED) visits after procedure. RESULTS: There was no difference in AE in ESG performed by gastroenterologists and bariatric surgeons. ESG performed by bariatric surgeons demonstrated a trend towards higher rate of re-operations within 30 days. ESG performed by gastroenterologists had more ED visits but did not lead to higher rate of re-intervention. LOS was shorter in ESG performed by gastroenterologists, but procedure time was longer. CONCLUSIONS: ESG is safely performed by both gastroenterologists and bariatric surgeons.

Role of endoscopic ultrasound in esophageal cancer.

Esophageal cancer (ECA) affects 1 in 125 men and 1 in 417 for women and accounts for 2.6% of all cancer related deaths in the United States. The associated survival rate depends on the stage of the cancer at the time of diagnosis, making adequate work up and staging imperative. The 5-year survival rate for localized disease is 46.4%, regional disease is 25.6%, and distant/metastatic disease is 5.2%. Additionally, treatment is stage-dependent, making staging all that much important. For nonmetastatic transmural tumors (T3) and/or those that have locoregional lymph node involvement (N), neoadjuvant therapy is recommended. Conversely, for those who have earlier tumors, upfront surgical resection is reasonable. While positron emission tomography/computed tomography and other cross sectional imaging modalities are exceptional for detecting distant disease, they are inaccurate in staging locoregional disease. Endoscopic ultrasound (EUS) has played a key role in the locoregional (T and N) staging of newly diagnosed ECA and has an evolving role in restaging after neoadjuvant therapy. There is even data to support that the use of EUS facilitates proper triaging of patients and may ultimately save money by avoiding unnecessary or futile treatment. This manuscript will review the current role of EUS on staging and restaging of ECA.

Prospective Study Assessing Impact of Ethylene Oxide Sterilization on Endoscopic Ultrasound Image Quality.

BACKGROUND & AIMS: Duodenoscope-associated transmission of infections has raised questions about efficacy of endoscope reprocessing using high-level disinfection (HLD). Although ethylene oxide (ETO) gas sterilization is effective in eradicating microbes, the impact of ETO on endoscopic ultrasound (EUS) imaging equipment remains unknown. In this study, we aimed to compare the changes in EUS image quality associated with HLD vs HLD followed by ETO sterilization. METHODS: Four new EUS instruments were assigned to 2 groups: Group 1 (HLD) and Group 2 (HLD + ETO). The echoendoscopes were assessed at baseline, monthly for 6 months, and once every 3 to 4 months thereafter, for a total of 12 time points. At each time point, review of EUS video and still image quality was performed by an expert panel of reviewers along with phantom-based objective testing. Linear mixed effects models were used to assess whether the modality of reprocessing impacted image and video quality. RESULTS: For clinical testing, mixed linear models showed minimal quantitative differences in linear analog score (P = .04; estimated change, 3.12; scale, 0-100) and overall image quality value (P = .007; estimated change, -0.12; scale, 1-5) favoring ETO but not for rank value (P = .06). On phantom testing, maximum depth of penetration was lower for ETO endoscopes (P < .001; change in depth, 0.49 cm). CONCLUSIONS: In this prospective study, expert review and phantom-based testing demonstrated minimal differences in image quality between echoendoscopes reprocessed using HLD vs ETO + HLD over 2 years of clinical use. Further studies are warranted to assess the long-term clinical impact of these findings. In the interim, these results support use of ETO sterilization of EUS instruments if deemed clinically necessary.

Management of pancreatic cysts and guidelines: what the gastroenterologist needs to know.

The prevalence of pancreatic cysts has increased significantly over the last decade, partly secondary to increased quality and frequency of cross-sectional imaging. While the majority never progress to cancer, a small number will and need to be followed. The management of pancreatic cysts can be both confusing and intimidating due to the multiple guidelines with varying recommendations. Despite the differences in the specifics of the guidelines, they all agree on several high-risk features that should get the attention of any clinician when assessing a pancreatic cyst: presence of a mural nodule or solid component, dilation of the main pancreatic duct (or presence of main duct intraductal papillary mucinous neoplasm), pancreatic cyst size ⩾3-4 cm, or positive cytology on pancreatic cyst fluid aspiration. Other important criteria to consider include rapid cyst growth (⩾5 mm/year), elevated serum carbohydrate antigen 19-9 levels, new-onset diabetes mellitus, or acute pancreatitis thought to be related to the cystic lesion.

Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial.

BACKGROUND AND AIMS: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. METHODS: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. RESULTS: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, -1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). CONCLUSIONS: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.).