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1.
Gastrointest Endosc ; 94(4): 760-773.e18, 2021 10.
Article in English | MEDLINE | ID: mdl-33887269

ABSTRACT

BACKGROUND AND AIMS: Consensus regarding an optimal algorithm for endoscopic treatment of papillary adenomas has not been established. We aimed to assess the existing degree of consensus among international experts and develop further concordance by means of a Delphi process. METHODS: Fifty-two international experts in the field of endoscopic papillectomy were invited to participate. Data were collected between August and December 2019 using an online survey platform. Three rounds were conducted. Consensus was defined as ≥70% agreement. RESULTS: Sixteen experts (31%) completed the full process, and consensus was achieved on 47 of the final 79 statements (59%). Diagnostic workup should include at least an upper endoscopy using a duodenoscope (100%) and biopsy sampling (94%). There should be selected use of additional abdominal imaging (75%-81%). Patients with (suspected) papillary malignancy or over 1 cm intraductal extension should be referred for surgical resection (76%). To prevent pancreatitis, rectal nonsteroidal anti-inflammatory drugs should be administered before resection (82%) and a pancreatic stent should be placed (100%). A biliary stent is indicated in case of ongoing bleeding from the papillary region (76%) or concerns for a (micro)perforation after resection (88%). Follow-up should be started 3 to 6 months after initial papillectomy and repeated every 6 to 12 months for at least 5 years (75%). CONCLUSIONS: This is the first step in developing an international consensus-based algorithm for endoscopic management of papillary adenomas. Surprisingly, in many areas consensus could not be achieved. These aspects should be the focus of future studies.


Subject(s)
Ampulla of Vater , Common Bile Duct Neoplasms , Consensus , Delphi Technique , Endoscopy , Humans , Treatment Outcome
2.
Gastroenterology ; 156(4): 1027-1040.e3, 2019 03.
Article in English | MEDLINE | ID: mdl-30452918

ABSTRACT

BACKGROUND & AIMS: Infected necrotizing pancreatitis is a highly morbid disease with poor outcomes. Intervention strategies have progressed from open necrosectomy to minimally invasive approaches. We compared outcomes of minimally invasive surgery vs endoscopic approaches for patients with infected necrotizing pancreatitis. METHODS: We performed a single-center, randomized trial of 66 patients with confirmed or suspected infected necrotizing pancreatitis who required intervention from May 12, 2014, through March 24, 2017. Patients were randomly assigned to groups that received minimally invasive surgery (laparoscopic or video-assisted retroperitoneal debridement, depending on location of collection, n = 32) or an endoscopic step-up approach (transluminal drainage with or without necrosectomy, n = 34). The primary endpoint was a composite of major complications (new-onset multiple organ failure, new-onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, bleeding and perforation of a visceral organ) or death during 6 months of follow-up. RESULTS: The primary endpoint occurred in 11.8% of patients who received the endoscopic procedure and 40.6% of patients who received the minimally invasive surgery (risk ratio 0.29; 95% confidence interval 0.11-0.80; P = .007). Although there was no significant difference in mortality (endoscopy 8.8% vs surgery 6.3%; P = .999), none of the patients assigned to the endoscopic approach developed enteral or pancreatic-cutaneous fistulae compared with 28.1% of the patients who underwent surgery (P = .001). The mean number of major complications per patient was significantly higher in the surgery group (0.69 ± 1.03) compared with the endoscopy group (0.15 ± 0.44) (P = .007). The physical health scores for quality of life at 3 months was better with the endoscopic approach (P = .039) and mean total cost was lower ($75,830) compared with $117,492 for surgery (P = .039). CONCLUSIONS: In a randomized trial of 66 patients, an endoscopic transluminal approach for infected necrotizing pancreatitis, compared with minimally invasive surgery, significantly reduced major complications, lowered costs, and increased quality of life. Clinicaltrials.gov no: NCT02084537.


Subject(s)
Cutaneous Fistula/etiology , Endoscopy, Digestive System/adverse effects , Intestinal Fistula/etiology , Laparoscopy/adverse effects , Pancreatic Fistula/etiology , Pancreatitis, Acute Necrotizing/surgery , Postoperative Complications/etiology , Video-Assisted Surgery/adverse effects , Adult , Aged , Debridement/methods , Drainage/methods , Endoscopy, Digestive System/economics , Female , Health Care Costs , Humans , Laparoscopy/economics , Male , Middle Aged , Quality of Life , Video-Assisted Surgery/economics
3.
Am J Gastroenterol ; 115(4): 555-561, 2020 04.
Article in English | MEDLINE | ID: mdl-32195731

ABSTRACT

OBJECTIVES: Exposure to ionizing radiation remains a hazard for patients and healthcare providers. We evaluated the utility of an artificial intelligence (AI)-enabled fluoroscopy system to minimize radiation exposure during image-guided endoscopic procedures. METHODS: We conducted a prospective study of 100 consecutive patients who underwent fluoroscopy-guided endoscopic procedures. Patients underwent interventions using either conventional or AI-equipped fluoroscopy system that uses ultrafast collimation to limit radiation exposure to the region of interest. The main outcome measure was to compare radiation exposure with patients, which was measured by dose area product. Secondary outcome was radiation scatter to endoscopy personnel measured using dosimeter. RESULTS: Of 100 patients who underwent procedures using traditional (n = 50) or AI-enabled (n = 50) fluoroscopy systems, there was no significant difference in demographics, body mass index, procedural type, and procedural or fluoroscopy time between the conventional and the AI-enabled fluoroscopy systems. Radiation exposure to patients was lower (median dose area product 2,178 vs 5,708 mGym, P = 0.001) and scatter effect to endoscopy personnel was less (total deep dose equivalent 0.28 vs 0.69 mSv; difference of 59.4%) for AI-enabled fluoroscopy as compared to conventional system. On multivariate linear regression analysis, after adjusting for patient characteristics, procedural/fluoroscopy duration, and type of fluoroscopy system, only AI-equipped fluoroscopy system (coefficient 3,331.9 [95% confidence interval: 1,926.8-4,737.1, P < 0.001) and fluoroscopy duration (coefficient 813.2 [95% confidence interval: 640.5-985.9], P < 0.001) were associated with radiation exposure. DISCUSSION: The AI-enabled fluoroscopy system significantly reduces radiation exposure to patients and scatter effect to endoscopy personnel (see Graphical abstract, Supplementary Digital Content, http://links.lww.com/AJG/B461).


Subject(s)
Artificial Intelligence , Endoscopy, Gastrointestinal , Fluoroscopy/methods , Radiation Exposure , Radiation Protection/methods , Aged , Female , Humans , Male , Middle Aged , Prospective Studies , Scattering, Radiation
4.
Esophagus ; 17(1): 3-10, 2020 01.
Article in English | MEDLINE | ID: mdl-31559513

ABSTRACT

It has been 10 years since peroral endoscopic myotomy (POEM) was reported for the first time, and POEM has currently become the standard treatment for achalasia and related disorders globally because it is less invasive and has a higher curative effect than conventional therapeutic methods. However, there are limited studies comparing the long-term outcomes of POEM with those of conventional therapeutic methods, particularly in the occurrence of gastroesophageal reflux disease (GERD) after therapy. With this background, we held a consensus meeting to discuss the pathophysiology and management of GERD after POEM based on published papers and experiences of each expert and to discuss the prevention of GERD and dealing with anti-acid drug refractory GERD. This meeting was held on April 27, 2018 in Tokyo to establish statements and finalize the recommendations using the modified Delphi method. This manuscript presents eight statements regarding GERD after POEM.


Subject(s)
Esophageal Achalasia/surgery , Gastroesophageal Reflux/physiopathology , Myotomy/adverse effects , Natural Orifice Endoscopic Surgery/methods , Consensus , Delphi Technique , Endoscopy, Digestive System/methods , Endoscopy, Digestive System/trends , Esophageal Achalasia/complications , Gastroesophageal Reflux/diagnosis , Gastroesophageal Reflux/etiology , Gastroesophageal Reflux/prevention & control , Humans , Myotomy/methods , Postoperative Complications/physiopathology , Tokyo/epidemiology
5.
Am J Gastroenterol ; 114(8): 1322-1342, 2019 08.
Article in English | MEDLINE | ID: mdl-31205135

ABSTRACT

INTRODUCTION: Detailed recommendations and guidelines for acute pancreatitis (AP) management currently exist. However, quality indicators (QIs) are required to measure performance in health care. The goal of the Acute Pancreatitis Task Force on Quality was to formally develop QIs for the management of patients with known or suspected AP using a modified version of the RAND/UCLA Appropriateness Methodology. METHODS: A multidisciplinary expert panel composed of physicians (gastroenterologists, hospitalists, and surgeons) who are acknowledged leaders in their specialties and who represent geographic and practice setting diversity was convened. A literature review was conducted, and a list of proposed QIs was developed. In 3 rounds, panelists reviewed literature, modified QIs, and rated them on the basis of scientific evidence, bias, interpretability, validity, necessity, and proposed performance targets. RESULTS: Supporting literature and a list of 71 proposed QIs across 10 AP domains (Diagnosis, Etiology, Initial Assessment and Risk Stratification, etc.) were sent to the expert panel to review and independently rate in round 1 (95% of panelists participated). Based on a round 2 face-to-face discussion of QIs (75% participation), 41 QIs were classified as valid. During round 3 (90% participation), panelists rated the 41 valid QIs for necessity and proposed performance thresholds. The final classification determined that 40 QIs were both valid and necessary. DISCUSSION: Hospitals and providers managing patients with known or suspected AP should ensure that patients receive high-quality care and desired outcomes according to current evidence-based best practices. This physician-led initiative formally developed 40 QIs and performance threshold targets for AP management. Validated QIs provide a dependable quantitative framework for health systems to monitor the quality of care provided to patients with known or suspected AP.


Subject(s)
Pancreatitis/diagnosis , Pancreatitis/therapy , Quality Indicators, Health Care , Advisory Committees , Analgesics/therapeutic use , Anti-Bacterial Agents/therapeutic use , Cholangiopancreatography, Endoscopic Retrograde , Cholecystectomy , Consensus , Delphi Technique , Disease Management , Drainage , Fluid Therapy , Gallstones/complications , Gallstones/diagnosis , Gallstones/therapy , Gastroenterologists , Hospitalists , Humans , Nutritional Support , Pain Management , Pancreatitis/etiology , Pancreatitis, Acute Necrotizing/diagnosis , Pancreatitis, Acute Necrotizing/etiology , Pancreatitis, Acute Necrotizing/therapy , Reproducibility of Results , Risk Assessment , Surgeons
6.
Gastrointest Endosc ; 89(1): 58-66.e3, 2019 01.
Article in English | MEDLINE | ID: mdl-30120957

ABSTRACT

BACKGROUND AND AIMS: Although EUS-guided celiac plexus neurolysis (EUS-CPN) is frequently performed, its efficacy for palliation of pain in pancreatic cancer is suboptimal. Recently, EUS-guided radiofrequency ablation (EUS-RFA) has been proposed as a palliative treatment option for pancreatic neoplasms. We performed a single-blind, randomized trial to compare the effectiveness of EUS-CPN and EUS-RFA for palliation of pain in pancreatic cancer. METHODS: Patients with abdominal pain because of locally advanced or metastatic pancreatic cancer underwent EUS-CPN (n = 14) or EUS-RFA (n = 12). EUS-RFA was performed using a 1F monopolar probe passed via a 19-gauge FNA needle, by targeting the area of celiac plexus or visualized ganglia. Primary outcome was pain severity as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire pancreatic cancer module (PAN26) administered pretreatment and at 2 and 4 weeks post-treatment. Secondary outcome measures were comparison of quality of life as determined by the PAN26 and EORTC Quality of Life Questionnaire core questionnaire (C30) and opioid analgesia use between the 2 groups. RESULTS: Both the PAN26 (49.0 vs 57.0, P < .001) and C30 (51.9 vs 64.4, P = .032) revealed less pain for EUS-RFA than for EUS-CPN. Also, the EUS-RFA cohort experienced significantly less-severe GI symptoms, were able to plan more for the future, and had better emotional functioning compared with the EUS-CPN group. CONCLUSIONS: Compared with EUS-CPN, EUS-RFA provided more pain relief and improved the quality of life for patients with pancreatic cancer. (Clinical trials registration number: NCT03152487.).


Subject(s)
Abdominal Pain/therapy , Adenocarcinoma/complications , Cancer Pain/therapy , Celiac Plexus , Ganglia, Sympathetic/surgery , Nerve Block/methods , Pancreatic Neoplasms/complications , Radiofrequency Ablation/methods , Abdominal Pain/etiology , Adenocarcinoma/pathology , Adenocarcinoma/secondary , Aged , Cancer Pain/etiology , Endosonography , Ethanol/therapeutic use , Female , Humans , Male , Middle Aged , Palliative Care/methods , Pancreatic Neoplasms/pathology , Single-Blind Method , Solvents/therapeutic use , Surgery, Computer-Assisted
7.
Gastrointest Endosc ; 89(2): 340-344, 2019 02.
Article in English | MEDLINE | ID: mdl-30193904

ABSTRACT

BACKGROUND AND AIMS: Rapid onsite evaluation of touch imprint cytology (ROSE-TIC) is a simple and rapid method used for the diagnosis of benign and malignant lesions. We evaluated the diagnostic accuracy of ROSE-TIC for advanced intestinal luminal and indeterminate pancreatobiliary lesions during endoscopy. METHODS: This is a retrospective descriptive study of patients who underwent endoscopy or ERCP between January 1, 2014 and December 31, 2016. It included patients who were referred for the treatment of intestinal luminal lesions or evaluation of indeterminate pancreatobiliary lesions. The slides were prepared by gently touching the specimen onto a glass slide and were examined under the microscope. The main outcome measure was to determine the diagnostic accuracy of ROSE-TIC by comparing the onsite cytology findings with the corresponding off-site histologic diagnosis. RESULTS: All 222 patients (106 pancreatobiliary and 116 GI lesions) had a prior benign diagnosis of intestinal luminal lesions or indeterminate diagnosis of pancreatobiliary lesions. The overall sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of ROSE-TIC were 97%, 85%, 83%, 97.2%, and 90%, respectively. The accuracy varied with the site of the biopsy sample. The accuracy was lowest for upper GI tract, where it was 85.2% but was 95% for lower GI tract lesions. CONCLUSIONS: By establishing a rapid onsite diagnosis, ROSE-TIC expedites decision-making on patient management. Prospective studies are needed to confirm these preliminary findings.


Subject(s)
Adenoma/pathology , Bile Duct Neoplasms/pathology , Carcinoma/pathology , Gastrointestinal Neoplasms/pathology , Gastrointestinal Stromal Tumors/pathology , Neuroendocrine Tumors/pathology , Pancreatic Neoplasms/pathology , Adenoma/diagnosis , Bile Duct Neoplasms/diagnosis , Biliary Tract Surgical Procedures , Biopsy , Carcinoma/diagnosis , Cholangiopancreatography, Endoscopic Retrograde , Clinical Decision-Making , Cytological Techniques , Endoscopic Mucosal Resection , Endoscopy, Digestive System , Gastrointestinal Neoplasms/diagnosis , Gastrointestinal Stromal Tumors/diagnosis , Humans , Melanoma/diagnosis , Melanoma/pathology , Narrow Band Imaging , Neuroendocrine Tumors/diagnosis , Pancreatic Neoplasms/diagnosis , Retrospective Studies , Sensitivity and Specificity , Time Factors
9.
Surg Endosc ; 32(4): 2159-2164, 2018 04.
Article in English | MEDLINE | ID: mdl-29075966

ABSTRACT

BACKGROUND: Endoscopic sutured gastroplasty (ESG) has evolved over time. With the advent of full-thickness endoscopic suturing, an efficient technique for ESG was developed and refined. METHODS: This prospective first-in-man trial started in April 2012 and represents the first use of full-thickness endoscopic suturing for primary obesity therapy. The trial focused on procedure development, reproducibility, safety, and short-term efficacy. The trial was performed at centers in five countries, in three phases. Phase I was evaluation of safety and technical feasibility of various procedure techniques; stitch patterns and sequences were assessed for efficiency, safety, and feasibility. Phase II entailed continued procedure refinement to establish a standardized technique. Phase III entailed evaluation of technical feasibility and weight loss outcomes in 77 patients; the procedure was performed using the standardized technique, and there was no procedure development. Data were prospectively collected into a registry. RESULTS: In Phase I, the procedure was created and modified to improve time efficiency. Safety and technical feasibility were established, and short-term weight loss was demonstrated. In Phase II, a number of stitch patterns were attempted, and the stitch pattern was modified and finalized. 22 patients were included, and 1-year total weight loss was 17.3 ± 2.6%. In Phase III, conformity with the final technique was high. 77 patients were included, with a mean BMI of 36.1 ± 0.6 kg/m2. Mean weight loss was 16.0 ± 0.8% at 6 months and 17.4 ± 1.2% at 12 months (n = 44). Postprocedural nausea, vomiting, and epigastric pain were frequently reported; there were no reported significant adverse events post-procedure or during the follow-up period. CONCLUSIONS: Following a methodical procedure development phase, ESG demonstrated safety and short-term efficacy in this trial. The procedure also achieved meaningful weight loss during the follow-up period.


Subject(s)
Gastroplasty/methods , Gastroscopy/methods , Obesity/surgery , Suture Techniques , Adult , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Reproducibility of Results , Treatment Outcome , Weight Loss
10.
Dig Endosc ; 29(1): 83-90, 2017 Jan.
Article in English | MEDLINE | ID: mdl-27199157

ABSTRACT

BACKGROUND AND AIM: Although lumen-apposing metal stents (LAMS) are increasingly being used for drainage of pancreatic fluid collections (PFC), their advantage over plastic stents is unclear. METHODS: In this retrospective case-control study, 20 patients who underwent PFC drainage using LAMS were matched with 40 patients treated with plastic stents according to PFC type (walled-off necrosis [WON] vs pseudocyst) and procedural technique (conventional vs multi-gate). Main outcome measures were treatment success, reintervention, clinical and stent-related adverse events, procedural duration, length of hospital stay (LOS) and hospital costs. RESULTS: At median follow up of 570 days, except for median procedural duration (8.5 vs 25 min, P < 0.001), there was no significant difference in treatment success (95.0 vs 92.5%, P = 0.99), reintervention (25.0 vs 30.0 %, P = 0.77), clinical (10.0 vs 12.5 %, P = 0.99) and stent-related adverse events (10.0 vs 2.5 %, P = 0.26) or median LOS (2 [IQR 1-5] vs 2 [IQR 1-7] days, P = 0.58) between patients treated with LAMS versus plastic stents. Although there was no difference for WON ($16 708 for LAMS vs $17 221 for plastic stents, P = 0.90), mean hospital costs were significantly lower for pseudocysts using plastic stents ($18 996 vs $58 649, P = 0.03). CONCLUSIONS: Although there is no difference in clinical outcomes, treating pseudocysts using plastic stents is less expensive. It is also possible that the short procedural duration is a surrogate marker for procedural complexity and this may drive the use of LAMS in sicker patients.


Subject(s)
Drainage/methods , Endosonography/methods , Pancreatic Diseases/surgery , Stents , Surgery, Computer-Assisted/methods , Adolescent , Adult , Aged , Aged, 80 and over , Case-Control Studies , Child , Female , Humans , Male , Middle Aged , Retrospective Studies , Young Adult
12.
Gastrointest Endosc ; 84(4): 649-55, 2016 Oct.
Article in English | MEDLINE | ID: mdl-26995690

ABSTRACT

BACKGROUND AND AIMS: Digital cholangioscopes provide higher-resolution imaging of the pancreatobiliary tract compared with fiberoptic instruments. The role of a new, digital, single-operator cholangiopancreatoscopy (SOC) system for diagnosis and treatment of pancreatobiliary disorders in clinical practice is not known. METHODS: We performed a multicenter, observational study of 105 consecutive patients with suspected pancreatobiliary disorders. The main outcome measures were (1) sensitivity and specificity of SOC visual appearance and biopsies in the diagnosis of indeterminate biliary strictures and (2) achieving complete duct clearance in patients with biliary or pancreatic duct stones. RESULTS: A total of 98 cholangioscopy and 7 pancreatoscopy procedures were performed in 105 patients. Superior views of the ductal lumen and mucosa were obtained in all 44 patients with indeterminate biliary strictures. Among the 44 patients who underwent SOC-guided biopsies, the specimen was adequate for histologic evaluation in 43 patients (97.7%). The sensitivity and specificity of SOC visual impression for diagnosis of malignancy was 90% (95% confidence interval [CI], 69.9%-97.2%) and 95.8% (95% CI, 79.8%-99.3%), respectively. The sensitivity and specificity of SOC-guided biopsies for diagnosis of malignancy was 85% (95% CI, 64.0%-94.8%) and 100% (95% CI, 86.2%-100%). In patients with biliary or pancreatic duct stones (N = 36), complete duct clearance with stone removal in 1 session was accomplished in 86.1% of patients (31/36). Three patients (2.9%) experienced SOC-related adverse events that included cholangitis in 2 patients and postprocedure pancreatitis in 1 patient. CONCLUSIONS: SOC has become an integral part of the ERCP armamentarium and has high accuracy in the evaluation of indeterminate biliary strictures. Complete stone clearance was achieved in all but 1 patient with challenging biliary or pancreatic duct stones. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01815619.).


Subject(s)
Adenocarcinoma/diagnosis , Bile Duct Neoplasms/diagnosis , Cholangiocarcinoma/diagnosis , Cholangiopancreatography, Endoscopic Retrograde , Cholelithiasis/diagnosis , Cholestasis/diagnosis , Endoscopy, Digestive System , Pancreatic Neoplasms/diagnosis , Adenocarcinoma/complications , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Aged , Bile Duct Diseases/diagnosis , Bile Duct Diseases/pathology , Bile Duct Diseases/surgery , Bile Duct Neoplasms/complications , Bile Duct Neoplasms/pathology , Bile Duct Neoplasms/surgery , Biliary Tract Surgical Procedures , Biopsy , Cholangiocarcinoma/complications , Cholangiocarcinoma/pathology , Cholangiocarcinoma/surgery , Cholangitis/epidemiology , Cholelithiasis/complications , Cholelithiasis/pathology , Cholelithiasis/surgery , Cholestasis/etiology , Cholestasis/pathology , Cholestasis/surgery , Endoscopic Ultrasound-Guided Fine Needle Aspiration , Female , Humans , Male , Middle Aged , Pancreatic Diseases/diagnosis , Pancreatic Diseases/pathology , Pancreatic Diseases/surgery , Pancreatic Neoplasms/complications , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/surgery , Pancreatitis/epidemiology , Postoperative Complications/epidemiology , Retrospective Studies , Sensitivity and Specificity
14.
Gastrointest Endosc ; 82(4): 608-14.e2, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26071061

ABSTRACT

BACKGROUND AND AIMS: Evaluation of indeterminate biliary strictures by brush cytology and intraductal biopsies is limited by low sensitivity. The utility of SpyGlass peroral cholangioscopy for diagnosis of malignant biliary strictures and cholangiocarcinoma (CCA), in particular, remains unclear. Our aim was to study the utility of SpyGlass peroral cholangioscopy and targeted biopsy for diagnosis of malignant biliary strictures and CCA. METHODS: In this systematic review, PubMed and Embase databases were reviewed for studies published to October 2014. The main outcomes of interest were sensitivity, specificity, and diagnostic odds ratio (DOR) of SpyGlass cholangioscopy in the diagnosis of malignant biliary strictures. RESULTS: The search yielded 10 studies involving 456 patients. The pooled sensitivity and specificity of cholangioscopy-guided biopsies in the diagnosis of malignant biliary strictures was 60.1% (95% confidence interval [CI], 54.9%-65.2%) and 98.0% (95% CI, 96.0%-99.0%), respectively. The pooled DOR to detect malignant biliary strictures was 66.4 (95% CI, 32.1-137.5). Four studies included patients who had previous negative imaging and brushings and/or intraductal biopsies. Among these 4 studies, the pooled sensitivity and specificity for diagnosis of malignant biliary strictures was 74.7% (95% CI, 63.3%-84.0%) and 93.3% (95% CI, 85.1%-97.8%), respectively. The pooled DOR was 46.0 (95% CI, 15.4-138.1). Only 1 study directly compared the yield of SpyBite biopsies with standard brushings and biopsies. SpyBite biopsies had a sensitivity of 76.5% compared with brushings (5.8%) and biopsies (29.4%). Six studies specifically reported the role of cholangioscopy with targeted biopsies in the diagnosis of CCA. The pooled sensitivity and specificity to detect CCA was 66.2% (95% CI, 59.7%-72.3%) and 97.0% (95% CI, 94.0%-99.0%), respectively. The pooled DOR to detect CCA was 79.7 (95% CI, 32.7-194.7). CONCLUSIONS: Our study suggests that SpyGlass cholangioscopy with SpyBite biopsies has moderate sensitivity for the diagnosis of malignant biliary strictures.


Subject(s)
Bile Duct Neoplasms/diagnosis , Bile Ducts/pathology , Cholangiocarcinoma/diagnosis , Cholestasis/diagnosis , Endoscopy, Digestive System/methods , Bile Duct Neoplasms/complications , Biopsy , Cholangiocarcinoma/complications , Cholestasis/etiology , Endoscopy, Digestive System/instrumentation , Humans , Sensitivity and Specificity
15.
Gastrointest Endosc ; 81(1): 104-10, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25123685

ABSTRACT

BACKGROUND: Although on-site cytopathology services have a significant impact on efficiency and accuracy of EUS-guided FNA (EUS-FNA), the availability of this service is variable. OBJECTIVE: To evaluate the impact of an intensive 2-day training program to educate endosonographers in EUS-related cytopathology. DESIGN: Pilot study. SETTING: Tertiary care medical center. SUBJECTS: Six endosonographers (5 male, median age, 35 years) with minimal previous cytopathology exposure comprised the study cohort. METHODS: Pre- and posttraining testing was administered. Training commenced with a cytopathology tutorial focusing on 4 performance measures: specimen adequacy, sample interpretation, specimen processing, and preliminary diagnosis. Eight live EUS-FNA cases were then performed, and study participants independently completed 4 questions based on performance measures for each case. The ability to independently smear and stain slides and operate a microscope was additionally assessed after a hands-on tutorial. MAIN OUTCOME MEASUREMENTS: Comparison of pretraining and posttraining scores, improvement in performance measures for live cases, and ability to independently handle specimens and operate a microscope. RESULTS: Compared with pretraining, mean posttraining test scores improved by 63% from 48 to 78 out of 100. Mean live case performance score was 95%. Performances improved from 89% on day 1 to 100% on day 2. After training, all endosonographers could independently smear/stain slides and operate a microscope. LIMITATIONS: Long-term impact is unclear. CONCLUSIONS: An intensive 2-day program was effective in training endosonographers in the basics of EUS-related cytopathology. Incorporating basic cytopathology in EUS fellowship curriculum will likely improve diagnostic performance of tissue acquisition procedures.


Subject(s)
Education, Medical, Continuing/methods , Endoscopic Ultrasound-Guided Fine Needle Aspiration/standards , Endosonography , Gallbladder Neoplasms/pathology , Gastroenterology/education , Pancreatic Diseases/pathology , Pathology/education , Quality Improvement , Adult , Female , Humans , Male , Microscopy , Middle Aged , Pancreatic Cyst/pathology , Pancreatic Neoplasms/pathology , Pancreatitis, Chronic/pathology , Pilot Projects , Specimen Handling
16.
Endoscopy ; 47(10): 884-90, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26165739

ABSTRACT

BACKGROUND AND STUDY AIM: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a significant and potentially life-threatening adverse event and is common in patients with suspected sphincter of Oddi dysfunction (SOD). Here we aimed to identify predictors of the risk in this population. PATIENTS AND METHODS: The Evaluating Predictors and Interventions in SOD (EPISOD) study prospectively enrolled 214 post-cholecystectomy patients with SOD type III in seven US centers. Patients were randomized, using a 2:1 allocation, to sphincterotomy or sham procedure, irrespective of the results of sphincter of Oddi manometry. Patients in the sphincterotomy arm who had elevated pancreatic sphincter pressure were randomized to biliary only or to dual (biliary and pancreatic) sphincterotomy. All but one patient received prophylactic pancreatic stents, but none received pharmacological prophylaxis. Post ERCP pancreatitis (PEP) was defined as acute pancreatitis within the subsequent 7 days. Blinded research coordinators at each site called patients at 1 week post-procedure. RESULTS: PEP occurred in 26 patients, in 10.6 % (15/141) in the sphincterotomy arm and 15.1 % (11/73) in the sham arm; unadjusted relative risk 0.71 (95 % confidence interval [95 %CI] 0.34 - 1.46). PEP rate was not significantly different in patients who received sphincterotomy compared with those undergoing sham treatment. In addition, the proportion was not statistically different in those who received biliary sphincterotomy alone (12/94; 12.8 % [95 %CI 6.0 % - 19.5 %]) compared with dual sphincterotomy (3/47; 6.4 % [95 %CI 0.0 % - 13.4 %]). Multivariate analysis identified an interaction between duration of ERCP and sedation type (P < 0.02). CONCLUSION: The performance of biliary or dual sphincterotomy does not increase the risk of PEP in patients suspected of SOD. However, the high rate of PEP in patients with suspected SOD, despite pancreatic stenting in expert centers, is confirmed in this prospective study. The combined effect of duration of ERCP and sedation type on the development of PEP should be further explored.Clinicaltrials.gov registration: NCT00688662.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Common Bile Duct Diseases/surgery , Pancreatitis/epidemiology , Postoperative Complications/epidemiology , Sphincter of Oddi Dysfunction/surgery , Sphincter of Oddi/physiopathology , Sphincterotomy, Endoscopic/adverse effects , Adult , Common Bile Duct Diseases/physiopathology , Female , Follow-Up Studies , Humans , Incidence , Male , Manometry , Middle Aged , Pancreatitis/diagnosis , Pancreatitis/etiology , Postoperative Complications/diagnosis , Pressure , Prognosis , Prospective Studies , Sphincter of Oddi/surgery , Sphincter of Oddi Dysfunction/diagnosis , Sphincter of Oddi Dysfunction/physiopathology , Stents , United States/epidemiology , Young Adult
17.
Gastrointest Endosc ; 80(6): 1056-63, 2014 Dec.
Article in English | MEDLINE | ID: mdl-24973173

ABSTRACT

BACKGROUND: When on-site cytopathology support is not available, EUS-guided fine needle aspiration (EUS-FNA) is performed for cell-block preparation to allow off-site interpretation. OBJECTIVE: To identify the number of passes required to obtain a diagnostic cell block by using a 25-gauge needle for sampling pancreatic masses. DESIGN: Randomized trial. SETTING: Tertiary care hospital. PATIENTS: Sixty-two patients with solid pancreatic mass lesions. INTERVENTIONS: EUS-FNA was performed by using a 25-gauge needle. After establishing a preliminary on-site diagnosis, patients were randomized to 2 or 4 FNA passes for a cell block. A cell block was evaluated by a pathologist blinded to on-site interpretation for the presence of a tissue pellet, histological core tissue size, and diagnostic accuracy. MAIN OUTCOME MEASUREMENTS: To determine the number of passes required to obtain a diagnostic cell block with a 25-gauge FNA needle. RESULTS: Sixty-two patients were randomized to undergo either 2 (n = 31) or 4 (n = 31) FNA passes for a cell block. Before randomization, an on-site diagnosis was established in all 62 patients (100%). The final diagnosis was adenocarcinoma in 45 (72.6%), neuroendocrine/other tumor in 7 (11.3%), and chronic pancreatitis in 10 (16.1%). There was no difference in the presence of a tissue pellet (93.5 vs 96.8%; P = .99), the median size of the histological core (0.006 vs 0.05 mm(2); P = .12), or the presence of a diagnostic cell block (80.6 vs 80.6%; P = .99) between patients randomized to 2 or 4 FNA passes, respectively. LIMITATIONS: Only pancreatic masses were evaluated. CONCLUSIONS: The 25-gauge FNA needle yielded a diagnostic cell block in only 81% of patients, irrespective of whether 2 or 4 FNA passes were performed. These findings have important implications for centers without on-site cytopathology services. (Clinical trial registration number NCT01809028.).


Subject(s)
Adenocarcinoma/pathology , Endoscopic Ultrasound-Guided Fine Needle Aspiration/methods , Neuroendocrine Tumors/pathology , Pancreatic Neoplasms/pathology , Pancreatitis, Chronic/pathology , Adult , Aged , Aged, 80 and over , Endoscopic Ultrasound-Guided Fine Needle Aspiration/instrumentation , Female , Humans , Male , Middle Aged , Needles , Single-Blind Method , Specimen Handling/methods
18.
Surg Endosc ; 28(10): 2877-83, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24789132

ABSTRACT

BACKGROUND: Transmural stents are placed at endoscopy to drain pancreatic fluid collections. This study evaluated the relationship between stent placement and treatment outcomes in patients undergoing endoscopic transmural drainage of uncomplicated pancreatic pseudocysts. METHODS: This is a retrospective study of all patients who underwent endoscopic drainage of uncomplicated pancreatic pseudocysts over a 10-year period. After dilating the transmural tracts in the range of 8-15 mm, single or multiple, 7 or 10Fr double-pigtail plastic stents were deployed. The main outcome measure was to evaluate the relationship between stent characteristics and the number of endoscopic interventions required to achieve resolution of the pancreatic pseudocyst (treatment success). RESULTS: Of 122 patients, 45 (36.9%) had 10Fr stents of which 30 patients (66.7%) had more than one stent; the remaining 77 (63.1%) patients had 7Fr stents of which 56 (72.7%) had more than one stent. The overall treatment success was 94.3%. Treatment was successful in 102 patients (83.6%) with one intervention; 13 patients (10.7%) required re-intervention for successful drainage and 7 patients (5.7%) failed endoscopic treatment. There was no significant difference in the number of interventions required for treatment success between patients with 7 or 10Fr stents (one intervention required in 87.7 vs. 90.5%, respectively; p = 0.766) and between patients with 1 or >1 stent (one intervention required in 88.9 vs. 88.6%, respectively; p = 0.999). On multiple logistic regression analysis, the stent size (OR 1.54; 95% CI 0.23-10.4) and number (OR 1.15; 95% CI 0.25-5.25) were not associated with the number of interventions required for treatment success when adjusted for pseudocyst size, location, drainage modality, the presence or absence of pancreatic duct stent and luminal compression. CONCLUSIONS: There appears to be no relationship between the number of interventions required for treatment success and stent characteristics in patients undergoing endoscopic transmural drainage of uncomplicated pancreatic pseudocysts.


Subject(s)
Drainage/methods , Endoscopy, Digestive System , Pancreatic Pseudocyst/therapy , Stents , Adult , Drainage/instrumentation , Equipment Design , Female , Humans , Male , Middle Aged , Patient Outcome Assessment , Retrospective Studies
19.
Dig Endosc ; 26 Suppl 1: 62-9, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24033879

ABSTRACT

Endoscopic ultrasound (EUS) is an indispensable tool for tissue acquisition in patients with gastrointestinal tumors. While fine-needle aspiration (FNA) has been routinely carried out for establishing tissue diagnosis, the emerging concept of tailoring chemotherapeutic agents based on molecular markers has increased the demand for core tissue procurement by means of EUS-guided fine-needle biopsy (EUS-FNB). In addition, FNB may offset the limitations of FNA wherein the diagnostic sensitivity is incumbent on the availability of an onsite cytopathologist. Given the increasing number of procedures being done, developing a unit-specific algorithmic approach for needle selection is important to improve the procedural efficiency and utilization of resources. Finally, the best outcomes can be attained only by practicing evidence-based techniques, procuring adequate quantity of sample for ancillary studies and processing the specimens appropriately.


Subject(s)
Biopsy, Fine-Needle , Endoscopy, Gastrointestinal/methods , Endosonography , Gastrointestinal Neoplasms/pathology , Evidence-Based Medicine , Humans , Sensitivity and Specificity
20.
Gut ; 62(1): 15-21, 2013 Jan.
Article in English | MEDLINE | ID: mdl-22315471

ABSTRACT

BACKGROUND: White light endoscopy with random biopsies is the standard for detection of intestinal metaplasia (IM) and neoplasia in patients with Barrett's oesophagus (BO). Narrow band imaging (NBI) highlights surface patterns that correlate with IM and neoplasia in BO. OBJECTIVE: To compare high-definition white light (HD-WLE) and NBI for detection of IM and neoplasia in BO. DESIGN: International, randomised, crossover trial comparing HD-WLE and NBI. Patients referred for BO screening/surveillance at three tertiary referral centres were prospectively enrolled and randomised to HD-WLE or NBI followed by other procedures in 3-8 weeks. During HD-WLE, four quadrant biopsies every 2 cm, together with targeted biopsies of visible lesions (Seattle protocol), were obtained. During NBI examination, mucosal and vascular patterns were noted and targeted biopsies were obtained. All biopsies were read by a single expert gastrointestinal pathologist in a blinded fashion. RESULTS: 123 patients with BO (mean age 61; 93% male; 97% Caucasian) with mean circumferential and maximal extents of 1.8 and 3.6 cm, respectively, were enrolled. Both HD-WLE and NBI detected 104/113 (92%) patients with IM, but NBI required fewer biopsies per patient (3.6 vs 7.6, p<0.0001). NBI detected a higher proportion of areas with dysplasia (30% vs 21%, p=0.01). During examination with NBI, all areas of high-grade dysplasia and cancer had an irregular mucosal or vascular pattern. CONCLUSIONS: NBI targeted biopsies can have the same IM detection rate as an HD-WLE examination with the Seattle protocol while requiring fewer biopsies. In addition, NBI targeted biopsies can detect more areas with dysplasia. Regular appearing NBI surface patterns did not harbour high-grade dysplasia/cancer, suggesting that biopsies could be avoided in these areas.


Subject(s)
Barrett Esophagus/pathology , Esophageal Neoplasms/pathology , Esophagoscopy/methods , Esophagus/pathology , Narrow Band Imaging , Adult , Aged , Aged, 80 and over , Cross-Over Studies , Female , Humans , Image-Guided Biopsy/methods , Male , Metaplasia , Middle Aged , Outcome Assessment, Health Care , Prospective Studies , Single-Blind Method
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