Clinical outcomes: endoscopic resection of duodenal ampullary lesions.

Background: Ampullary adenomas are lesions at the duodenum's major papilla commonly associated with familial adenomatous polyposis (FAP) but may also occur sporadically. Historically, ampullary adenomas were removed surgically, however endoscopic resection has become the preferred method of resection. Most of the literature on management of ampullary adenomas are small single-center retrospective reviews. The objective of this study is to describe endoscopic papillectomy outcomes to further refine management guidelines. Methods: This is a retrospective study of patients who underwent endoscopic papillectomy. Demographic data were included. Details regarding lesions and procedures were also collected, including endoscopic impression, size, resection method and adjunctive therapies. Chi-square, Kruskal-Wallis rank-sum, and t-tests were performed. Results: A total of 90 patients were included. 60% patients (54 of 90) had pathology-proven adenomas. 14.4% of all lesions (13 of 90) and 18.5% of adenomas (10 of 54) were treated with APC. Among APC-treated lesions, 36.4% developed recurrence (4 of 11) vs. 7.1% developed residual lesion (1 of 14) (P=0.019). 15.6% of all lesions (14 of 90) and 18.5% of adenomas (10 of 54) reported complications, and the most common was pancreatitis (11.1% and 5.6%). Median follow-up time was 8 months for all lesions and 14 months (range, 1-177 months) for adenomas, with time to recurrence 30 and 31 months (range, 1-137 months), respectively. Recurrence was observed in 16.7% of all lesions (15 of 90) and 20.4% of adenomas (11 of 54). Endoscopic success was observed in 69.2% of all lesions (54 of 78) and 71.4% of adenomas (35 of 49) after removing patients lost to follow-up. Conclusions: Endoscopic papillectomy is an effective method for managing duodenal adenomas. Pathology-proven adenoma should undergo surveillance for at least 31 months. Lesions treated with APC may require closer follow-up and for a prolonged period.

Long-term outcomes of endoscopic mucosal resection for early-stage esophageal adenocarcinoma.

BACKGROUND: With growing application of endoscopic therapy for early-stage esophageal cancer, we sought to review our experience of endoscopic mucosal resections (EMRs). The aim of our study was to understand the natural course of these patients, especially with positive margins. METHODS: A prospectively maintained database of all patients undergoing endoscopic therapies at Georgetown University Hospital for esophageal cancer was used for the analysis between 2010 and 2020. RESULTS: Of 80 patients in the EMR database, 35 were performed as index cases for esophageal adenocarcinoma. Majority (74.3%) had a pre-treatment ultrasound confirming absence of regional adenopathy. There were no post-EMR bleeding or perforation events requiring re-intervention. Complete R0 resection was achieved in 22/35 (62.9%) after initial EMR. Thirteen patients had positive margins. Of these 13 patients, only 7 patients underwent repeat endoscopic resection, 2 underwent subsequent esophagectomy, 2 received definitive radiation given poor surgical candidacy, and 2 were lost to follow-up. Overall and 5-year survival of all patients undergoing EMR was 67.9 months and 85%, respectively. Subset analysis of the 13 patients with R1 resection demonstrated an overall survival of 49.2 months and 60% 5-year survival vs overall survival of 78.9 months and 93% 5-year survival for R0 resection. At a median follow-up of 60.5 months, cancer recurrence occurred in 3 patients. All of them were successfully managed with repeat EMR. CONCLUSIONS: Endoscopic resections represent a safe and effective treatment for early-stage esophageal cancer. Patients with high-risk features should be counseled to undergo an esophagectomy if they are operable candidates.

Minimally Invasive Intragastric Approach to Gastroesophageal Junction Disease.

BACKGROUND: A minimally invasive intragastric approach to the gastroesophageal junction (GEJ) allows resection of intramural disease while avoiding disruption of the lower esophageal sphincter and vagus nerves. Few surgeons use this approach; thus little is known regarding its indications, feasibility, technical aspects, complication profile, and long-term outcomes. This study reviewed the experience with this technique. METHODS: A retrospective review was performed of a prospectively maintained, Institutional Review Board-approved database covering the period from January 1, 2005 to August 1, 2017. Indications, operative details, postoperative complications, and outcomes were assessed. RESULTS: There were 12 patients identified. The mean age of these patients was 51.9 years. The indications for resection included 10 symptomatic leiomyomas, one gastrointestinal stromal tumor, and three cancers of the GEJ. Mean and median length of stay were 4.9 and 2.5 days, respectively. There were two postoperative esophageal leaks managed with laparoscopic repair. Of the 3 patients with cancer, 2 underwent an R0 resection, whereas 1 patient underwent an R1 resection. There were no other complications or recurrences. Mean follow-up was 6.0 years (range, 0.5 to 12.6 years); no patients had stricture or symptomatic gastroesophageal reflux on long term follow-up. CONCLUSIONS: Resection of selected intramural GEJ disorders through a minimally invasive transgastric approach can be performed safely with acceptable morbidity and good long-term results. The approach allows preservation of the lower esophageal sphincter and vagus nerves, a potential advantage compared with other surgical alternatives to resection in this region.

Underuse of exon mutational analysis for gastrointestinal stromal tumors.

BACKGROUND: Tyrosine kinase inhibitors (TKI) have become the guideline-recommended therapy for high-risk resected and advanced gastrointestinal stromal tumors (GISTs). Exon mutational analysis (EMA) is used to inform pretherapy response to TKI and may predict overall prognosis. Despite these benefits, EMA remains underused, and its impact on TKI therapy decision-making remains unexplored. MATERIALS AND METHODS: A retrospective cohort was established from 104 patients receiving treatment for GISTs from 2006 to 2017. Current National Comprehensive Cancer Network guidelines indicate that EMA should be considered for all patients undergoing TKI therapy to identify genotypes that are likely, or unlikely, to respond to treatment. We first tracked guideline-considered EMA use and subsequent impact on treatment decision-making. A questionnaire was then administered to gastrointestinal medical oncologists to assess EMA perception. RESULTS: Among 104 GIST patients, 54 (52%) received TKI therapy. Of these, only 22 (41%) received EMA. Informed by EMA, treatment decisions included 59% who continued with original TKI therapy, 32% who switched to an alternative TKI, and 9% who discontinued or received no TKI. Although 92% of physicians indicated EMA was a valuable tool, only 62% indicated they used it "frequently" or "always" to inform treatment decisions. CONCLUSIONS: Less than half of patients receiving TKI therapy for GISTs received EMA at a comprehensive cancer center. Despite this low uptake, when it was performed, EMA guided alternative treatment decision in 41% of patients. Physician survey responses indicated that interventions targeting physician education and an electronic medical record reminder may improve EMA uptake.

Programmed Death Ligand 1: A Step Toward Immunoscore for Esophageal Cancer.

BACKGROUND: This study sought to evaluate the effect of tumor-infiltrating lymphocyte (TIL) density and programmed death ligand 1 (PD-L1) expression on the prognosis of esophageal cancer. METHODS: Banked tissue specimens from 53 patients who underwent esophagectomies for malignancy at a single institution over a 6-year period were stained for cluster of differentiation 3 (CD3), CD8, and PD-L1. Tumors were characterized as staining high or low density for CD3 and CD8, as well as positive or negative for PD-L1. TIL density and PD-L1 expression were analyzed in the context of survival, recurrence, and perioperative characteristics. RESULTS: Median follow-up was 823 days, with 92.5% survival and 26.8% recurrence rates. All tumors were adenocarcinomas. Neoadjuvant chemotherapy was given in 56.6% of cases, and neoadjuvant radiotherapy was given in 37.7%. High CD3 density was found in 83%, whereas high CD8 density was found in 56.6%. A total of 18.9% of the tumors stained positive for PD-L1. Survival was significantly shorter in Kaplan-Meier analysis for patients with primary tumors staining positive for PD-L1 (log rank: p = 0.05). Multivariable analysis controlling for neoadjuvant therapy, TIL markers, PD-L1, age, and sex found no significant difference in recurrence or survival. CONCLUSIONS: Positive staining for PD-L1 may be a prognostic marker for decreased survival in esophageal adenocarcinoma. Additional TIL cell types should be investigated for creation of an esophageal cancer Immunoscore. PD-L1 has potential as a therapeutic target.

Post-endoscopic procedure satisfaction scores: Can we improve?

AIM: To organize post-procedure satisfaction data into a useful reference and analyze patient-centered parameters to find trends that influence patient satisfaction. METHODS: A robust database of two cohorts of outpatients that underwent an endoscopic procedure at Georgetown University Hospital at two separate three-month intervals ranging from November 2012 to January 2013 and November 2015 to January 2016 was compiled. Time of year was identical to control for weather/seasonal issues that may have contributed to the patient experience. The variables recorded included age, sex, body mass index (BMI), type of procedure, indication for procedure, time of the procedure, length of the procedure, type of prep used, endoscopist, satisfactory score, and comments/reasons for score. For continuous variables, differences in averages were tested by two sample t-test, Wilcoxon rank sum test, and ANOVA as appropriate. For categorical variables, differences in proportions between two groups were tested by χ2 test. Correlation test and linear regression analyses were conducted to examine relationships between length of procedure and continuous predictors. A P value < 0.05 used to indicate statistically significant relationship. RESULTS: The primary outcome of this study was to assess if telephone outreach after an endoscopic intervention was a satisfactory method of obtaining post-procedure satisfaction scores from patients at a tertiary care center. With the addition of post-procedure calls, instilled in January 2014, the response rate was 40.5% (508/1256 patients) from a prior completion rate of 3.4% (31/918) with the mail out survey initially. There was a statistically significant improved response rate pre and post intervention with P < 0001. The secondary outcome of this study was to assess if we could use predictive analytics to identify independent predictors of procedure length, such as gender, age, type of procedure, time of procedure, or BMI. The combined pre and post intervention data was used in order to optimize the power to identify independent predictors of procedure length. The total number of patient's data analyzed was 2174. There was no statistically significant difference in procedure length between males and females with P value 0.5282. However, there was a small (1 min), but statistically significant difference (P = 0.0185) in procedure length based on the time of day the procedure took place, with afternoon procedures having a longer duration than morning procedures. The type of procedure was an independent predictor of procedure length as demonstrated with P value < 0.0001. There is a statistically significant correlation between age and procedure length, although it is only a weak relationship with a correlation coefficient < 0.3. Contrary to patient age, BMI did not have a statistically significant correlation with procedure length (P = 0.9993), which was also confirmed by linear regression analysis. CONCLUSION: Our study proves calling patients after endoscopy improves post-procedure satisfaction response rates and changing procedural time allotment based on patient characteristics would not change endoscopic workflow.

Gastric Adenocarcinoma: A Multimodal Approach.

Despite its declining incidence, gastric cancer (GC) remains a leading cause of cancer-related deaths worldwide. A multimodal approach to GC is critical to ensure optimal patient outcomes. Pretherapy fine resolution contrast-enhanced cross-sectional imaging, endoscopic ultrasound and staging laparoscopy play an important role in patients with newly diagnosed ostensibly operable GC to avoid unnecessary non-therapeutic laparotomies. Currently, margin negative gastrectomy and adequate lymphadenectomy performed at high volume hospitals remain the backbone of GC treatment. Importantly, adequate GC surgery should be integrated in the setting of a multimodal treatment approach. Treatment for advanced GC continues to expand with the emergence of additional lines of systemic and targeted therapies.

The added value of using mutational profiling in addition to cytology in diagnosing aggressive pancreaticobiliary disease: review of clinical cases at a single center.

BACKGROUND: This study aimed to better understand the supporting role that mutational profiling (MP) of DNA from microdissected cytology slides and supernatant specimens may play in the diagnosis of malignancy in fine-needle aspirates (FNA) and biliary brushing specimens from patients with pancreaticobiliary masses. METHODS: Cytology results were examined in a total of 30 patients with associated surgical (10) or clinical (20) outcomes. MP of DNA from microdissected cytology slides and from discarded supernatant fluid was analyzed in 26 patients with atypical, negative or indeterminate cytology. RESULTS: Cytology correctly diagnosed aggressive disease in 4 patients. Cytological diagnoses for the remaining 26 were as follows: 16 negative (9 false negative), 9 atypical, 1 indeterminate. MP correctly determined aggressive disease in 1 false negative cytology case and confirmed a negative cytology diagnosis in 7 of 7 cases of non-aggressive disease. Of the 9 atypical cytology cases, MP correctly diagnosed 7 as positive and 1 as negative for aggressive disease. One specimen that was indeterminate by cytology was correctly diagnosed as non-aggressive by MP. When first line malignant (positive) cytology results were combined with positive second line MP results, 12/21 cases of aggressive disease were identified, compared to 4/21 cases identified by positive cytology alone. CONCLUSIONS: When first line cytology results were uncertain (atypical), questionable (negative), or not possible (non-diagnostic/indeterminate), MP provided additional information regarding the presence of aggressive disease. When used in conjunction with first line cytology, MP increased detection of aggressive disease without compromising specificity in patients that were difficult to diagnose by cytology alone.

Effect of propofol anesthesia on force application during colonoscopy.

BACKGROUND: Sedation is frequently used during colonoscopy to control patient discomfort and pain. Propofol is associated with a deeper level of sedation than is a combination of a narcotic and sedative hypnotic and, therefore, may be associated with an increase in force applied to the colonoscope to advance and withdraw the instrument. OBJECTIVE: To compare force application to the colonoscope insertion tube during propofol anesthesia and moderate sedation. DESIGN: An observational cohort study of 13 expert and 12 trainee endoscopists performing colonoscopy in 114 patients. Forces were measured by using the colonoscopy force monitor, which is a wireless, handheld device that attaches to the insertion tube of the colonoscope. SETTING: Community ambulatory surgery center and academic gastroenterology training programs. PATIENTS: Patients undergoing routine screening or diagnostic colonoscopy with complete segment force recordings. MAIN OUTCOME MEASUREMENTS: Axial and radial forces and examination time. RESULTS: Axial and radial forces increase and examination time decreases significantly when propofol is used as the method of anesthesia. LIMITATIONS: Small study, observational design, nonrandomized distribution of sedation type and experience level, different instrument type and effect of prototype device on insertion tube manipulation. CONCLUSIONS: Propofol sedation is associated with a decrease in examination time and an increase in axial and radial forces used to advance the colonoscope.

Segmental increases in force application during colonoscope insertion: quantitative analysis using force monitoring technology.

BACKGROUND: Colonoscopy is a frequently performed procedure that requires extensive training and a high skill level. OBJECTIVE: Quantification of forces applied to the external portion of the colonoscope insertion tube during the insertion phase of colonoscopy. DESIGN: Observational cohort study of 7 expert and 9 trainee endoscopists for analysis of colonic segment force application in 49 patients. Forces were measured by using the colonoscopy force monitor, which is a wireless, handheld device that attaches to the insertion tube of the colonoscope. SETTING: Academic gastroenterology training programs. PATIENTS: Patients undergoing routine screening or diagnostic colonoscopy with complete segment force recordings. MAIN OUTCOME MEASUREMENTS: Axial and radial force and examination time. RESULTS: Both axial and radial force increased significantly as the colonoscope was advanced from the rectum to the cecum. Analysis of variance demonstrated highly significant operator-independent differences between segments of the colon (zones) in all axial and radial forces except average torque. Expert and trainee endoscopists differed only in the magnitude of counterclockwise force, average push/pull force rate used, and examination time. LIMITATIONS: Small study, observational design, effect of prototype device on insertion tube manipulation. CONCLUSION: Axial and radial forces used to advance the colonoscope increase through the segments of the colon and are operator independent.

Cystic duct remnant mucocele in a liver transplant recipient.

Cystic duct remnant mucocele is an extremely rare complication of liver transplantation in children. Surgical correction is usually required for cystic duct remnant mucocele when it causes biliary obstruction. We describe a 14-month-old liver transplant recipient who presented with biliary obstruction 1 month after orthotopic liver transplantation with an end-to-end choledochocholedocal biliary anastomosis for hepatoblastoma. US, CT and cholangiography findings were consistent with mucocele of the allograft cystic duct remnant. Surgery was not needed in our patient because the mucocele and biliary obstruction had resolved on repeat imaging most likely due to guidewire manipulation during cholangiography, resulting in opening of the cystic duct remnant orifice and drainage into the common duct.

Single-step EUS-guided pancreatic pseudocyst drainage using a large channel linear array echoendoscope and cystotome: results in 11 patients.

CONTEXT: EUS-guided transmural drainage of pancreatic pseudocyst has been reported using a linear array echoendoscope; however, placement of large 10 French stent was not feasible because of the limited diameter of the working channel. Recently linear array echoendoscopes with large working channel (3.7 to 3.8 mm) and newer accessories for pancreatic cyst puncture have become available; however, clinical data on their efficacy and safety in pancreatic pseudocyst drainage is not available. OBJECTIVE: To evaluate efficacy and safety of a one-step real time EUS-guided pancreatic pseudocyst drainage approach using a 3.8 mm channel linear array echoendoscope and cystotome. DESIGN: Prospective case series. SETTING: Tertiary care hospital endoscopy unit. PATIENTS AND INTERVENTIONS: A total of 12 EUS-guided pancreatic pseudocyst drainage procedures were performed in 11 patients with symptomatic pancreatic pseudocyst using a 3.8 mm channel linear array echoendoscope and cystotome. MAIN OUTCOME MEASUREMENTS: Complete resolution of pancreatic pseudocyst on imaging. RESULTS: Successful puncture of pancreatic pseudocyst and placement of 1 or 2 stents (10 Fr) was successful in all patients who were considered eligible for EUS-guided pancreatic pseudocyst drainage. Overall 9 patients out of a total of 11 (82%) were managed successfully with EUS-guided pseudocyst drainage. Two recurrences were noted over a mean follow-up period of 4 months (range 3-6 months). One patient underwent successful repeat drainage and the other patient was managed with surgical cystogastrostomy because of infected cyst contents. No major complication occurred. LIMITATIONS: Uncontrolled, small sample size. CONCLUSIONS: A single-step approach using a large channel (3.8 mm) linear array echoendoscope and cystotome appears feasible. This approach appears safe and effective in managing selected patients with symptomatic pancreatic pseudocysts.

EUS-guided fiducial placement for CyberKnife radiotherapy of mediastinal and abdominal malignancies.

BACKGROUND: The CyberKnife frameless image-guided stereotactic radiosurgery system delivers radiation doses to tumors with high precision by use of real-time image guidance. Radiographic markers (or fiducials) implanted at the tumor site are used as reference points by the system to target the radiation beams. Diagnostic and interventional EUS have multiple applications in the multidisciplinary approach to tumors. OBJECTIVE: The goal of this prospective study was to evaluate the safety and feasibility of placing fiducials in mediastinal and intra-abdominal tumors under EUS guidance. DESIGN: Patients were evaluated for EUS-guided fiducial placement. A linear echoendoscope was used to localize the tumor, insert a 19-gauge fine needle in the target area, and place the fiducials through the needle lumen. The position of the fiducials was verified by EUS and by fluoroscopy. SETTING: Georgetown University Hospital, between February 2005 and August 2005. PATIENTS: Thirteen patients scheduled to undergo CyberKnife radiation therapy. RESULTS: EUS-guided fiducial placement was successful in a total of 11 of 13 patients (84.6%). The locations of the tumors were as follows: retrocrural area at the dome of the diaphragm, porta hepatis, gastroesophageal junction, mediastinum, thoracic paraspinal area, and pancreas. A total of 3 to 6 fiducials were placed in each patient. An infectious complication developed in 1 patient within 30 days of the procedure. CONCLUSION: EUS-guided fiducial placement in lesions of the mediastinum and abdomen is a feasible and safe technique that can be used to mark a tumor site and guide CyberKnife radiation therapy. This new application of interventional EUS further expands the role of EUS in the multidisciplinary approach to the oncology patient.

Role of EUS and EUS-guided FNA in the diagnosis of symptomatic rectosigmoid endometriosis.

BACKGROUND: Rectosigmoid endometriosis is an underrecognized cause of GI symptoms in women. Pelvic magnetic resonance imaging and CT have a low sensitivity in making this diagnosis. The role of EUS and EUS-guided FNA (EUS-FNA) in the diagnosis of rectosigmoid endometriosis in symptomatic patients is not well studied. METHODS: A review of medical records identified 5 women who were diagnosed with rectosigmoid endometriosis by EUS and EUS-FNA over a period of 1 year. OBSERVATIONS: Five women with nonspecific GI complaints underwent EUS examination of a rectosigmoid subepithelial mass found on colonoscopy. EUS revealed a hypoechoic lesion infiltrating the muscularis propria and the serosa of the rectal wall, and extending outside the rectal wall, findings consistent with rectosigmoid endometriosis. This diagnosis was confirmed by EUS-FNA, surgical exploration, and/or the patient's clinical course. CONCLUSIONS: EUS and EUS-FNA are noninvasive, sensitive techniques for the diagnosis of rectosigmoid endometriosis in symptomatic patients.

Pancreatic tuberculosis diagnosed with endoscopic ultrasound guided fine needle aspiration.

CONTEXT: Isolated pancreatic tuberculosis is rare in the Western world. Its clinical presentation often mimics pancreatic malignancy and the diagnosis is usually not suspected or confirmed prior to laparotomy. Endoscopic ultrasound guided fine needle aspiration cytology has proved to be an excellent tool for the cytological diagnosis of pancreatic and peripancreatic masses. However, this technique has not been reported for diagnosing pancreatic or peripancreatic tuberculosis. CASE REPORT: We describe a 57-year-old South Asian man with pancreatic tuberculosis who presented with fever of undetermined origin and a pancreatic mass on imaging. He was successfully treated with anti-tuberculosis regimen following confirmation of his diagnosis with endoscopic ultrasound guided fine needle aspiration cytology. CONCLUSIONS: Pancreatic tuberculosis should be suspected in patients having a pancreatic mass, particularly if patient presents with fever and lived in, or traveled to, an area of endemic tuberculosis or exposed to tuberculosis. When the diagnosis is suspected, endoscopic ultrasound guided fine needle aspiration cytology of the pancreatic lesion can confirm the diagnosis and so avoid an unnecessary explorative laparotomy or pancreatic resection.