Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.

INTRODUCTION: Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). METHODS: Post-marketing surveillance data from January 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event. RESULTS: A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events. CONCLUSION: Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.

Robotic Versus Laparoscopic Colorectal Resection: Are We There Yet?

BACKGROUND: Laparoscopy-assisted surgery (LAS) for colorectal cancer (CRC) was first described in 1991 and robotic-assisted surgery (RAS) for CRC was first reported in 2002; robotic-assisted colorectal surgery (RACS) is becoming increasingly popular. However, data comparing its outcomes to other established techniques remain limited to small case series. Our primary goal was to review the mortality outcome difference between laparoscopic versus robotic elective colon resection at a small, community hospital. STUDY DESIGN: We conducted a retrospective review of 2089 patients at the South Atlantic division for cases who underwent robotic and laparoscopic colectomies at our division in 2014-2018. All cases were elective surgeries and analysis was performed within these two subgroups. RESULTS: In this study, 306 patients underwent robotic colorectal surgery versus 1783 patients who underwent laparoscopic-assisted colorectal surgery. Readmission rate within 30 days of operation was significantly lower for laparoscopic-assisted colorectal resection (LACR) versus RACS (445.4% vs. 53.9%, p= 0.006). However, the length of hospital stay was significantly shorter for RACS with a median of three days (interquartile range {IQR}: 2-5) versus four days (IQR: 3-7) for LACR (p=0.0001). There were no significant differences between the two groups for post-operative incisional hernias, anastomotic leaks, post-operative pain control, surgical site infections, or rate of conversion to an open procedure. CONCLUSION:  Our study showed a similar outcome between LACR and RACS for post-operative incisional hernias, anastomotic leaks, post-operative pain control, surgical site infections, and rate of conversion to an open procedure. Also, our study showed a readmission rate within 30 days of operation was significantly lower for LACR versus RACS. However, the length of hospital stay was significantly shorter for RACS with a median of three days when compared to LACR. Future research should focus on surgeon-specific variables, such as comfort, ergonomics, distractibility, and ease of use, as other ways to potentially distinguish robotic from laparoscopic colorectal surgery.

Early Buried Bumper Syndrome: A Rare Complication of Percutaneous Endoscopic Gastrostomy Tube Placement.

Early buried bumper syndrome (BBS) is a rare complication of percutaneous endoscopic gastrostomy (PEG) tube placement where the internal bolster gets "buried" in the gastrocutaneous fistulous tract. BBS is usually a late complication with onset > four weeks of PEG placement. We present a case of early BBS presenting at day 17 after PEG tube placement where the internal bolster got embedded in the subcutaneous fat just outside the gastric wall. The patient underwent urgent endoscopic removal of the buried bumper with the simple external traction, followed by the successful placement of a new tube through the same tract. Early diagnosis and prompt management are of paramount importance to avoid an ominous outcome.

Endoscopic ultrasound-guided liver biopsy using a 22-G fine needle biopsy needle: a prospective study.

BACKGROUND: Endoscopic ultrasound-guided liver biopsy (EUS-LB) using a 19-gauge (19-G) EUS needle is becoming increasingly popular. We evaluated the efficacy and safety of a 22-G EUS fine needle biopsy (FNB) needle for performing EUS-LB. METHODS: Patients referred for evaluation of elevated liver enzymes and without obstructive disease requiring endoscopic retrograde cholangiopancreatography (ERCP) were included. Using a 22-G FNB needle, two passes were made from the left lobe and one from the right. The main outcome measure was adequacy of the specimen for histology interpretation, and the secondary outcome was the safety of EUS-guided liver biopsy with a 22-G FNB needle. Patients were followed for post-procedure complications for 30 days. RESULTS: 40 patients (median age 61 years; 26 women) underwent EUS-LB. Analyzing by needle passes, the median longest core fragment was 12 mm (1st quartile - 3rd quartile 10 mm - 16.25 mm, interquartile range [IQR] 6.25 mm) from the left lobe and 11 mm (10 mm - 15.75 mm, IQR 5.75 mm) from the right lobe. The median cumulative core length per patient was 55 mm (44.5 mm - 68 mm, IQR 23.5 mm). The median cumulative number of complete portal triads (CPTs) per patient was 42 (28.5 - 53, IQR 24.5). The specimen was considered adequate in all 40 patients (100 %). Self-limiting abdominal pain was reported in 6 patients (15 %). CONCLUSIONS: EUS-LB using a 22-G FNB needle is a safe and viable alternative to the use of larger gauge needles, yielding adequate tissue for evaluation of parenchymal disease in 100 % of the patients.

Manometric Subtypes of Ineffective Esophageal Motility.

OBJECTIVES: Ineffective esophageal motility (IEM) is characterized by well-defined manometric criteria. However, much variation exists within the diagnosis: Some patients exhibit exactly the required five weak swallows to make the diagnosis. Others show consistently ineffective swallows with total absence of any normal swallow. "We hypothesize" there are two different manometric subtypes of IEM; IEM Alternans (IEM-A) and IEM Persistens (IEM-P). METHODS: A total of 231 IEM patients were identified by high-resolution manometry (HRM). IEM defined by distal contractile integral (DCI) <450 mm Hg/s/cm in ≥50% of test swallows. Abnormal reflux study was defined by excess total number of reflux episodes, abnormal esophageal acid exposure, or positive symptom association. RESULTS: A total of 195 (84%) patients had IEM-A and 36 (16%) had IEM-P. A striking gender difference with 34% of IEM-A being males compared to 53% of IEM-P. (P=0.03). Mean age of IEM-P (59.6 years+/-13.1) was greater than IEM-A (55.5 years+/-13.6) (P=0.04). Mean lower esophageal sphincter (LES) resting pressure was significantly lower in IEM-P (20.8 mm Hg+/-1.4) than IEM-A (29 mm Hg+/-1.2) (P=0.002). There was no difference in LES-integrated relaxation pressure (IRP), bolus transit, or manometric presence of hiatal hernia between the two groups. Out of 146, 89 (61%) patients had abnormal reflux study. Esophageal acid exposure in upright position was significantly higher in IEM-P than IEM-A (3.5 vs. 1.7%, P=0.04). Poor gastric acid control on proton pump inhibitor (PPI) was more prevalent among IEM-P patients (58%) than IEM-A (27%) (P=0.007). In subgroup analysis of 41 IEM patients with dysphagia, DCI for liquid swallows was significantly lower in IEM-P (111+/-142 mm Hg/s/cm) compared to IEM-A (421+/-502 mm Hg/s/cm) (P=0.04), lower mean LES resting pressure in IEM-P (16.6+/-9 mm Hg) than IEM-A (31.7+/-18 mm Hg) (P=0.01). CONCLUSIONS: There are two distinct manometric IEM subtypes; IEM-P with an older male predominance, more advanced reflux disease, weaker LES, and worse response to PPI; likely a more advanced manifestation than IEM-A. However, the question if there are different etiologies underlying the two subtypes remains to be answered.

Ineffective Esophageal Motility (IEM): the Old-New Frontier in Esophagology.

Ineffective esophageal motility (IEM) is characterized by distal esophageal contraction amplitude of <30 mmHg on conventional manometry (Blonski et al. Am J Gastroenterol. 103(3):699-704, 2008), or a distal contractile integral (DCI) < 450 mmHg*s*cm on high-resolution manometry (HRM) (Kahrilas et al. Neurogastroenterol Motil. 27(2):160-74, 2015) in≥50 % of test swallows. IEM is the most common abnormality on esophageal manometry, with an estimated prevalence of 20-30 % (Tutuian and Castell Am J Gastroenterol. 99(6):1011-9, 2004; Conchillo et al. Am J Gastroenterol. 100(12):2624-32, 2005). Non-obstructive dysphagia has been considered to be frequently associated with severe esophageal peristaltic dysfunction. Defective bolus transit (DBT) on multichannel intraluminal impedance testing was found in more than half of IEM patients who presented with dysphagia (Tutuian and Castell Am J Gastroenterol. 99(6):1011-9, 2004), highlighting the functional defect of this manometric finding. Treatment of IEM has been challenging because of lack of promotility agents that have a definite effect on esophageal function.

Approach to the patient with dysphagia.

Dysphagia is a fascinating symptom. It is ostensibly simple when defined by trouble swallowing, yet its subtleties in deciphering and its variations in pathophysiology almost mandate a thorough knowledge of medicine itself. With patience and careful questioning, a multitude of various disorders may be suggested before an objective test is performed. Indeed, the ability to diligently and comprehensively explore the symptom of dysphagia is not only rewarding but also a real test for a physician who prides himself or herself on good history taking.

Anatomical Location of Pathology Is Predictive of Prolonged Fluoroscopy Time During ERCP: A Multicenter American Study.

BACKGROUND: Different factors have been associated with prolonged fluoroscopy time (FT) during endoscopic retrograde cholangiopancreatography (ERCP). AIM: We hypothesize that FT depends on both the anatomical location of the pathology managed during ERCP and the complexity of the ERCP. METHODS: Three centers participated in a retrospective multi-center cohort study. Data on patient demographics, ERCP complexity, and the location of pathology were collected. The relationships between FT and the location of pathology, ERCP complexity, patient demographics, and ERCP maneuvers, respectively, were analyzed. Prolonged FT was defined as a FT > 10 min. RESULTS: A total of 442 cases underwent ERCP in three different centers (301 cases, 76 cases, and 65 cases in centers A, B, and C, respectively) by six endoscopists. The median FT for all cases was 282 (range 8-3,516) s. Mean FT increased progressively according to anatomical location in the order extrahepatic cases {n = 298; mean FT 292 [95 % confidence interval (CI) 263-322] s}, pancreatic cases [n = 27; mean FT 359 (95 % CI 200-517) s], and intrahepatic cases [n = 117; mean FT 736 s (95 % CI 635-836) s]. Mean FT increased progressively with the complexity scale, with mean FT for Grade I, 218 (95 % CI 138-299) s; Grade II, 295 (95 % 261-329) s; Grade III, 586 (95 % CI 508-663) s; Grade IV, 636 (95 % CI 437-834) s. Multivariable analysis confirmed that prolonged FT was independently associated with anatomical location of the targeted pathology during ERCP-but not with ERCP complexity and endoscopy center. CONCLUSION: Prolonged FT during ERCP is associated most strongly with intrahepatic cases. FT can be used most effectively as a quality measure if it is stratified according to presence or absence of intrahepatic cases.