bluuebunny/crossref_metadata_2025_split huggingface dataset:
906 To Cut or Not to Cut – Clinical Efficacy of Endoscopic Sphincterotomy in Recurrent Acute Pancreatitis From Functional Biliary Sphincter of Oddi Disorder: A Systematic Review and Meta-Analysis
Authors: Chandan Saurabh , Mohan Babu P. , Mashiana Harmeet , Dhindsa Banreet , Braseth Annie , Sayles Harlan , Jha Lokesh , Singh Shailender , Adler Douglas G. 
Published: October 2019

INTRODUCTION:
Functional biliary Sphincter of Oddi disorder, previously referred to as Sphincter of Oddi Dysfunction, is an established cause of recurrent acute pancreatitis which is defined as two or more episodes of documented acute pancreatitis per year. Data on the efficacy of endoscopic sphincterotomy in preventing future episodes of pancreatitis is limited. We performed a systematic review and meta-analysis to evaluate the clinical efficacy of index endoscopic sphincterotomy in patients with Recurrent Acute Pancreatitis secondary to manometrically proven functional biliary Sphincter of Oddi disorder. Our goal was to assess reduction in episodes of pancreatitis following sphincterotomy, and not to assess chronic pain in these patients.

METHODS:
We conducted a search of several databases including PubMed, EMBASE, Google-Scholar, Scopus and Cochrane Review (from 1960 to October 2018). Random-effects model was used for analysis. Heterogeneity between study-specific estimates was calculated using Cochran Q statistical test, 95% confidence interval (CI) and I2 statistics. Publication bias was ascertained, qualitatively, by visual inspection of funnel plot and quantitatively, by the Egger test.

RESULTS:
Our initial search yielded 3201 results. Of 1936 studies screened, 12 met inclusion criteria. A total of 396 patients with recurrent acute pancreatitis and abnormal manometry findings were included from these studies in the final analysis. The interventions performed were as follows: Endoscopic biliary sphincterotomy in 212 (53.5%), endoscopic pancreatic sphincterotomy in 19 (4.8%) and dual biliary and pancreatic sphincterotomy in 165 (41.6%) patients. Technical success ranged from 99 to 100%.The pooled estimate for clinical success following index sphincterotomy was 68.4% (95% CI 57.6-77.4; I2 = 71.4%). Lone endoscopic biliary sphincterotomy was successful in 43/60 (71.6%) patients. The pooled estimate for proportion of patients with post-ERCP pancreatitis was 23.2% (95% CI 16.6-31.4; I2 = 44.4%). The follow up duration ranged from 6 to 120 months. There was no evidence of publication bias, based on funnel plot analysis and Egger’s test.

CONCLUSION:
Our study highlights the utility and clinical efficacy of endoscopic sphincterotomy in patients with recurrent acute pancreatitis secondary to Functional biliary Sphincter of Oddi disorder. We conclude that 68.4% of patients improved after endoscopic sphincterotomy and that it can be considered in patients with recurrent acute pancreatitis.
910 Comparison of Safety and Efficacy Between Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection in the Treatment of Superficial Esophageal Cancers - A Meta-Analysis Update
Authors: Rajabalan Ajai , Suresh Kumar Vishnu Charan , Patthipati Venkata Suresh , Mani Vishnu 
Published: October 2019

INTRODUCTION:
From radical esophagectomy, we have advanced towards endoscopic procedures for the treatment of esophageal cancers without lymph node involvement, superficial esophageal cancers (SEC). Endoscopic mucosal resection (EMR) is a widely accepted treatment modality for SEC due to its minimal invasive nature, low cost and excellent patient tolerance but has limitations. Endoscopic submucosal dissection (ESD) was developed to overcome these limitations. However, ESD has several disadvantages owing to longer procedural times and higher complication rates. The use of ESD is still being debated in the United States. We did a systematic review and meta-analysis to compare the efficacy and safety of EMR and ESD for the treatment of superficial esophageal cancers.

METHODS:
Literature search was done from electronic databases including PubMed, Cochrane, and Embase from inception until November 2018. Data from 9 relevant studies were extracted and meta-analysis with Random effects model was done using RevMan 5.3.

RESULTS:
There were 692 lesions in the EMR group and 468 lesions in the ESD group. Patient characteristics were available for only 3 out of 9 studies which showed a mean age of 65.66 years [Male-86.3%, Female-13.7%] in the EMR group and a mean age of 65.66 years [Male-83%, Female-17%] in the ESD group. Our primary outcomes were En-bloc resection rate (EBR) and curative resection rate (CRR) which were analyzed in all 9 studies. Bleeding and perforation rates were our secondary outcomes. EBR was achieved in 319 out of 692 lesions by EMR and 455 out of 468 lesions by ESD [OR 50.93, 95%CI (23.29, 111.37), P < 0.00001, I2 = 23%], favoring ESD over EMR. The CRR was significantly better with ESD when compared to EMR [OR 10.96, 95%CI (3.78, 31.74), P < 0.0001, I2 = 72%]. There was no significant difference in the occurrence of bleeding [OR 1.48, 95%CI (0.37, 5.87), P = 0.58, I2 = 0%] but the rate of perforation was higher with ESD [OR 0.40, 95%CI (0.18, 0.91), P = 0.03, I2 = 6%]

CONCLUSION:
Our Study shows that the EBR and CRR are better achieved with ESD than EMR. Although there was no significant difference in bleeding, the risk of perforation was higher in ESD. ESD is a complex time consuming procedure that requires great technical expertise and is performer dependent. With careful selection of patients and advanced endoscopic skills, ESD might give better overall outcomes than EMR. Non-randomization and usage of data from heterogeneous practice settings are the limitations of our study data.
912 Comparison of Diagnostic Yield of Cytology versus Histology on Samples Obtained During Endoscopic Ultrasound-Guided Fine-Needle Biopsy (EUS-FNB)
Authors: Plafsky Liza , Diaz Liege , Satiya Jinendra , Girotra Mohit 
Published: October 2019

INTRODUCTION:
The advent of endoscopic ultrasound (EUS) has vastly improved access to several gastrointestinal lesions, thereby leading to increased diagnostic capability. Moreover, improved core tissue sampling is now possible with fine needle biopsy (EUS-FNB) needle, as opposed to aspiration (FNA) alone. However, the practice of sample handling is highly individualized due to lack of standardization as to whether core sample should be sent only in histology (in formalin), or cytology (in cytolyte) or both. This study was abstracted to compare the diagnostic yield of cytology versus histology on core tissue obtained from the same lesion, using the same EUS-FNB needle.

METHODS:
Single endoscopist at a large tertiary referral center conceptualized a prospective EUS database between October 2017 and February 2019, where a 22-gauge FNB needle was used to obtain core tissue samples, which were sent for cytology and histology. After IRB approval, retrospective analysis of this database was performed. Patient’s demographics, medical history, imaging, indication for EUS, EUS findings, and cytology/histology results were analyzed.

RESULTS:
Out of 226 therapeutic EUS' performed by single endoscopist during study period, 103 samples were collected using 22-gauge FNB needle [solid masses (62), lymph nodes (18) & solid-cystic lesions (23)]. 28 samples were sent for cytology, 29 for histology, and 46 for both (passes equally divided). Out of these 46 samples, 42 were consistent between cytology and histology, but 4 were discordant; in all 4 cases, histology provided the conclusive information. In 3 cases, histology provided the diagnosis of cancer while cytology was reported negative. In the fourth case, cytology was inconclusive while histology was definitely negative for carcinoma. These samples were obtained from 2 pancreatic masses, one gastric subepithelial lesion, and one lymph node, and pathology showed pancreatic adenocarcinoma, GIST, and persistent follicular lymphoma, respectively. 22-gauge needles were used for all these procedures, and no complications were noted.

CONCLUSION:
Our study demonstrates 8% inconsistency between cytology and histology on core samples obtained using EUS-FNB. In all discordant cases, histology provided more accurate information than cytology. Larger, multi-centric and prospective studies are needed to ascertain the best practice to make the diagnostic process more efficient, accurate, and cost-effective.
920 Efficacy and Safety of EUS-Guided Gastroenterostomy for Gastric Outlet Obstruction: A Systematic Review and Meta-Analysis
Authors: Khan Ali T. , Zhang Xiaocen , Herman Michael , Lung Edward 
Published: October 2019

INTRODUCTION:
For symptomatic gastric outlet obstruction (GOO), enteral stents or surgical gastroenterostomy (GE) are treatment options that are limited by short term efficacy or high procedural complication rates. With the advent of lumen apposing metal stents (LAMS) it is possible to use a minimally invasive EUS guided approach to create a gastro-enteric fistula. We conducted a systematic review and meta-analysis to evaluate and compare the efficacy and safety of EUS-guided gastroenterostomy for GOO.

METHODS:
MEDLINE, EMBASE, and SCOPUS were utilized to search for eligible studies that reported on technical success, clinical success and adverse events of this procedure from 2012-2019. Technical success was defined as the ability to create a GE with a LAMS and clinical success was defined as the ability to tolerate an oral diet. Patients with benign and malignant GOO were included. All studies were retrospective and the quality of eligible studies was assessed by the NHBLI tool. A sub-analysis was done to analyze the direct and balloon assisted techniques and procedural times. Figure 1 depicts the flow chart used for study screening.

RESULTS:
A total of 5 studies (n = 147 patients) were included in the analysis. The mean age of patients undergoing EUS guided GE was 64 years with 50% females. Most common etiology for GOO was malignancy with 77% of cases. Pooled technical success was 96% (95% CI 0.91-0.99) although 5 cases initially involved LAMS misdeployment requiring repositioning. Clinical success was 80% (95% CI 0.58-0.96) and a total of 6 adverse events (2% 95% CI 0.00 – 0.08) occurred including intra-procedural bleeding, peritonitis and perforation requiring surgery. Figures 2a–c highlights the technical success, clinical success and adverse events of EUS guided GE. On procedural sub-analysis, a total of 74 cases were done with the direct GE technique while 27 cases underwent balloon-assisted GE. Stent misdeployments occurred in 6.7% of cases of the direct technique and 9.1% of balloon assisted cases. Procedural time was comparatively lower with the direct technique averaging 35.6 mins compared to 84 mins for the balloon assisted technique.

CONCLUSION:
EUS guided gastroenterostomy is an efficacious and safe procedure for patients with gastric outlet obstruction. Although the direct GE technique appears to require less procedural time, more studies need to be done to assess the optimal procedural technique.
925 Incremental Value of Endoscopic Ultrasound in Detecting Pancreatic Lesions in Patients With MEN1
Authors: Ahmed Osman , Cazacu Irina , Weston Brian , Ross William , Lee Jeffrey , Bhutani Manoop S. 
Published: October 2019

INTRODUCTION:
Multiple endocrine neoplasia type 1 is an inherited disorder that affects the endocrine glands caused by a mutation in the MEN1 gene. MEN1 is associated with pituitary, parathyroid and pancreatic lesions (specifically tumors of islet cells and neuroendocrine tumors) and the prevalence of pancreatic lesions can range as high as 75%. Currently, CT and MRI are used to investigate pancreatic lesions in MEN1. Endoscopic ultrasound can also be used to assess the pancreas and also allows for tissue sampling. The main disadvantage of EUS is that it is invasive and requires an endoscopy with anesthesia to perform. In this study, we examine the incremental value of performing EUS in patients with MEN1 who were referred after CT or MRI.

METHODS:
This was a retrospective study of all patients with a mutation-proven MEN1 diagnosis who underwent EUS between 2009 and 2018. Patients who had previous resection for pancreatic lesions were excluded. The cross-sectional image closest to the date of the EUS was used as a comparison. Relevant data including lesion characteristics were extracted. The location of the lesions were also recorded as multiple locations could affect future treatment options.

RESULTS:
A total of 42 patients with MEN1 underwent EUS for pancreatic lesions. The mean age was 51.9 years (SD +/- 13.7) and 24 (57%) patients were female. A total of 31 patients had a CT while 11 patients had an MRI to compare to EUS. For patients who underwent CT followed by EUS, CT showed 45 lesions (1.5 lesions per procedure) while EUS showed 78 pancreatic lesions (2.5) (P < 0.05). The mean size of the largest lesion was 22.4 mm (SD 14) with EUS, and 16.7 mm (SD 17). In 14 cases, EUS saw a lesion in an area of the pancreas that was not seen on CT, while only in 3 cases the CT saw a lesion in a location not seen on EUS. Twenty-five (81%) of patients in the CT group underwent FNA to obtain cytology. For patients who underwent MRI followed by EUS, MRI showed 19 lesions while EUS showed 48 lesions (P < 0.05). The mean size of the largest lesion was 14.3 (SD 10.5) with EUS, and 6.9 with MRI (SD 7.8). In 8 cases, EUS saw a lesion in a territory that was not seen in on MRI. Six (55%) patients in the MRI comparison underwent FNA. Overall, no complications were noted from performing EUS or FNA.

CONCLUSION:
Despite advances in imaging by CT and MRI, EUS continues to play an important incremental role in detecting and mapping pancreatic lesions in patients with MEN1.
926 POEM Is a Safe and Effective Treatment for Achalasia: A Large Single Center Experience
Authors: Moosvi Zain , Abadir Alexander , Cao Vicky , Samarasena Jason , Chang Kenneth J. 
Published: October 2019

INTRODUCTION:
Achalasia is a primary motility disorder characterized by aperistalsis and failure of lower esophageal sphincter relaxation. Traditionally, treatment modalities have consisted of drug therapy, botulinum toxin injections, laparoscopic Heller myotomy, and balloon pneumatic dilatation. However, in the past several years, the novel technique peroral endoscopic myotomy (POEM) has gained popularity, as prior studies have suggested that it offers excellent short-term outcomes. In this study, we analyze the efficacy of POEM with a focus on both short-term and long-term outcomes.

METHODS:
This retrospective study utilized collected data at our tertiary referral center. A total of 71 patients underwent POEM. 18 patients were lost to follow-up post-procedure. 47 patients were included in the short-term assessment, defined as less than 6 months removed from the procedure, while 15 patients were included in the long-term assessment, defined as greater than or equal to 6 months removed from the procedure. Eckhardt score was assessed before POEM and afterwards for short-term follow-up and long-term follow-up.

RESULTS:
Mean age was 56.5 years old. 54% of patients were female. Mean short term follow-up time was 2.96 months. Mean long-term follow-up time was 13.0 (8-27) months. The mean pre-POEM Eckhardt score was 7.6. The mean short-term post-POEM Eckhardt score was 1.2 (P < 0.001) while the mean long-term post-POEM Eckhardt score was 1.8 (P < 0.001). There was no significant difference between short-term and long-term Eckhardt scores. Additionally, there were no adverse outcomes or effects in any of the 65 POEM cases.

CONCLUSION:
This study was one of the largest single-center studies that examining the efficacy and safety of POEM . Eckhardt scores decreased significantly after POEM, remained significantly decreased at longer-term follow-up, and there were no adverse outcomes. In short, this study supports that POEM is a safe, effective, and durable option for the treatment of achalasia.
928 Efficacy and Safety of Endoscopic Full Thickness Resection (EFTR) of Colorectal Neoplasms Using the Full Thickness Resection Device (FTRD): A Systematic Review and Pooled Analysis
Authors: Dasari Chandra S. , Nutalapati Venkat , Duvvuri Abhiram , Chandrasekar Viveksandeep Thoguluva , Malik Afeerah , Kohli Divyanshoo , Sharma Prateek 
Published: October 2019

INTRODUCTION:
Endoscopic full thickness resection (EFTR) using the Full Thickness Resection Device (FTRD) is being increasingly used for the resection of colorectal lesions not amenable to conventional endoscopic resection. We conducted a systematic review and pooled analysis to assess the efficacy and safety of this device for resection of colorectal lesions.

METHODS:
An electronic database search was conducted in PubMed/MEDLINE, Embase, Google Scholar and Cochrane databases to identify studies that used EFTR for colorectal lesions using the over the scope FTRD. The primary outcome was the rate of technical success and R0 resection. Secondary outcomes included complications (bleeding, perforation and post polypectomy syndrome) and the total procedure time. Pooled rates were reported with 95% Confidence Interval (CI) with heterogeneity (I2). We used a random effects model to calculate pooled rates and used the I-square statistic to quantify heterogeneity.

RESULTS:
A total of 7 studies were included in the final analysis - 559 patients with 563 lesions removed using FTRD; mean age 67 years, males 59.3% and mean lesion size of 15.7 mm. Mean follow up of the studies was 4.0 months. The colorectal lesions resected by EFTR included: 32% cancers, 0.01% neuroendocrine tumors and 67% adenomas. The pooled overall technical success was 91% (95% CI 88% - 93%, I2 = 0%) (Figure 1) with a R0 resection rate of 81% (95% CI 74% -86%, I2 = 62%) (Figure 2). The pooled rates of immediate bleeding, perforation, and post polypectomy syndrome were 5% 3% and 2% respectively. The overall combined rate of any complication (bleeding, perforation and post polypectomy syndrome) was 9.2% (6.1%-13.5%). The mean total procedure time was 47.76 min (95%CI 40-55, I2 = 84%) (Figure 3).

CONCLUSION:
Endoscopic full thickness resection (EFTR) using over the scope Full Thickness Resection Device (FTRD) appears to be a effective and safe technique for the resection of non-lifting colorectal lesions, with a >90% technical success rate, R0 resection rate of >80% and an overall complication rate of < 10%.
938 Positive Results From REGENERATE: A Phase 3 International, Randomized, Placebo-Controlled Study Evaluating Obeticholic Acid Treatment for NASH
Authors: Younossi Zobair , Ratziu Vlad , Loomba Rohit , Rinella Mary , Anstee Quentin M. , Goodman Zachary , Bedossa Pierre , Geier Andreas , Beckebaum Susanne , Newsome Philip , Sheridan David , Trotter James , Knapple Whitfield , Lawitz Eric , Kowdley Kris , Montano-Loza Aldo , Boursier Jerome , Mathurin Philippe , Bugianesi Elisabetta , Mazzella Giuseppe , Olveira Antonio , Cortez-Pinto Helena , Graupera Isabel , Orr David , Gluud Lise Lotte , Dufour Jean-Francois , Shapiro David , Campagna Jason , Zaru Luna , MacConell Leigh , Shringarpure Reshma , Harrison Stephen , Sanyal Arun 
Published: October 2019

INTRODUCTION:
Obeticholic acid (OCA), an FXR agonist, improved both fibrosis and histologic features of nonalcoholic steatohepatitis (NASH) in the Ph2 FLINT study. This Month 18 pre-specified interim analysis of the Ph3 REGENERATE study evaluated the effect of OCA on liver histology in patients (pts) with biopsy-confirmed NASH1.

METHODS:
Pts with NASH and fibrosis stages F2-3 (ITT), and an exploratory group of F1 pts with metabolic syndrome, were randomized to placebo (PBO), OCA 10 mg, or OCA 25 mg QD. Primary endpoints were fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of liver fibrosis per liver biopsy. The safety population included all randomized and dosed pts (F1-3, N = 1968). Clinical outcomes will be evaluated at the end-of-study.

RESULTS:
The ITT population included 931 pts (PBO [n = 311], OCA 10mg [n = 312] or OCA 25mg [n = 308]), comprised of 44% F2 and 56% F3. Baseline characteristics were well-balanced across groups. Results in Table 1. The primary fibrosis endpoint was met by 11.9% PBO, 17.6% OCA 10 mg (P = 0.0446 vs PBO), and 23.1% OCA 25 mg (P = 0.0002 vs PBO) pts (ITT). The primary NASH endpoint was not statistically significant (ITT); however significantly more pts on OCA 25 mg showed improvements in hepatocellular ballooning (P = 0.0011 vs PBO) and lobular inflammation (P = 0.0322 vs PBO). Dose-dependent reductions in ALT, AST and GGT were observed. Pruritus was the most common AE (19% PBO, 28% OCA 10mg, 51% OCA 25 mg) and was predominantly mild to moderate in severity (severe pruritus: < 1% PBO, < 1% OCA 10mg, 5% OCA 25 mg). SAEs occurred in 11% PBO, 11% OCA 10 mg and 14% OCA 25 mg pts. Increases in LDLc with OCA were observed by Week 4, but approached baseline by Month 18 (OCA 25mg: LS mean change Wk4 +22.6 mg/dL, M18 + 4.0 mg/dL). Three deaths occurred; none were considered treatment-related (PBO n = 2; OCA 25 mg n = 1).

CONCLUSION:
Treatment with OCA 25mg improved liver fibrosis, key histologic features of steatohepatitis and liver biochemistry, demonstrating consistent efficacy with an overall AE profile similar to previous studies.
1

Interim analysis results at 18 months are based on surrogate endpoints and impact on clinical outcomes has not been confirmed. The REGENERATE study is ongoing to confirm the clinical benefit of OCA.
942 Low Incidence of Bleeding Complications in Patients With Cirrhosis Undergoing Transesophageal Echocardiography: A Systematic Review and Meta-Analysis
Authors: Odewole Mobolaji , Sen Ahana , Mufti Arjmand R. , Agrawal Deepak , Nguyen Anh D. , Singal Amit G. , Rich Nicole E. 
Published: October 2019

INTRODUCTION:
The presence of esophageal varices is considered a relative contraindication to transesophageal echocardiography (TEE) by some professional societies, so gastroenterologists are often consulted to perform upper endoscopy prior to TEE in patients with cirrhosis. Our study’s aim was to perform a systematic review and meta-analysis to quantify the risk of bleeding complications in cirrhosis patients following TEE.

METHODS:
Two reviewers searched MEDLINE and EMBASE databases from January 1992 to January 2019 for studies reporting bleeding complications following TEE in patients with cirrhosis. Data was extracted by two authors using standardized forms. The pooled incidence rate was calculated using the DerSimonian and Laird method for a random-effects model. The modified Newcastle-Ottawa Scale (NOS) was used to assess study quality. This study was conducted in accordance with Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines.

RESULTS:
We identified 16 studies meeting inclusion criteria comprising 3415 unique cirrhosis patients. Nine studies (n = 3009) assessed risk of intraoperative TEE during LT and 7 studies (n = 406) included cirrhosis patients undergoing TEE for other indications; upper endoscopy was performed prior to TEE in 3 out of 9 and 7 out of 7 of those studies, respectively. The pooled risk of bleeding complications post-TEE was 1.0% (95%CI 0.0 – 2.0%) across all studies. The proportion of patients with bleeding complications was similar among patients undergoing intraoperative TEE during LT compared to those undergoing TEE for other reasons (1.1% vs 2.2%, P = 0.06). Further, bleeding rates were similar among patients in the subgroup of studies with mean MELD > 18 compared to studies with mean MELD < 18 (1.9% vs 1.3%, P = 0.31). Three studies had NOS quality scores < 5, 6 had a score of 5–7, and 7 studies had quality scores >7. Overall, the cohorts were representative and included patients with various etiologies of cirrhosis, though most were retrospective in design and lacked a control group. Detailed data on patient-level factors impacting bleeding complications (including degree of liver dysfunction and coagulopathy) were inconsistently reported and limited across studies.

CONCLUSION:
There is a low risk of bleeding complications in cirrhosis patients following TEE, suggesting TEE is safe and risk stratification with upper endoscopy may not be necessary.