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2.
Clin Gastroenterol Hepatol ; 20(12): 2780-2789, 2022 12.
Article in English | MEDLINE | ID: mdl-35307593

ABSTRACT

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


Subject(s)
Equipment Contamination , Ethylene Oxide , Humans , Prospective Studies , Equipment Reuse , Disinfection/methods
3.
Gastrointest Endosc ; 93(4): 914-923, 2021 04.
Article in English | MEDLINE | ID: mdl-32739484

ABSTRACT

BACKGROUND AND AIMS: The accurate measurement of technical skill in ERCP is essential for endoscopic training, quality assurance, and coaching of this procedure. Hypothesizing that technical skill can be measured by analysis of ERCP videos, we aimed to develop and validate a video-based ERCP skill assessment tool. METHODS: Based on review of procedural videos, the task of ERCP was deconstructed into its basic components by an expert panel that developed an initial version of the Bethesda ERCP Skill Assessment Tool (BESAT). Subsequently, 2 modified Delphi panels and 3 validation exercises were conducted with the goal of iteratively refining the tool. Fully crossed generalizability studies investigated the contributions of assessors, ERCP performance, and technical elements to reliability. RESULTS: Twenty-nine technical elements were initially generated from task deconstruction. Ultimately, after iterative refinement, the tool comprised 6 technical elements and 11 subelements. The developmental process achieved consistent improvements in the performance characteristics of the tool with every iteration. For the most recent version of the tool, BESAT-v4, the generalizability coefficient (a reliability index) was .67. Most variance in BESAT scores (43.55%) was attributed to differences in endoscopists' skill, indicating that the tool can reliably differentiate between endoscopists based on video analysis. CONCLUSIONS: Video-based assessment of ERCP skill appears to be feasible with a novel instrument that demonstrates favorable validity evidence. Future steps include determining whether the tool can discriminate between endoscopists of varying experience levels and predict important outcomes in clinical practice.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Clinical Competence , Humans , Reproducibility of Results
6.
Lancet Gastroenterol Hepatol ; 5(2): 132-141, 2020 02.
Article in English | MEDLINE | ID: mdl-31780277

ABSTRACT

BACKGROUND: Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients. METHODS: In this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete. FINDINGS: Between July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients-76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87-1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients-six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up. INTERPRETATION: Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP. FUNDING: American College of Gastroenterology.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Indomethacin/administration & dosage , Pancreatitis/prevention & control , Administration, Rectal , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Dose-Response Relationship, Drug , Double-Blind Method , Female , Follow-Up Studies , Humans , Incidence , Male , Middle Aged , Pancreatitis/epidemiology , Pancreatitis/etiology , Retrospective Studies , Risk Factors , Severity of Illness Index , Treatment Outcome , United States/epidemiology
7.
Cancer Med ; 8(7): 3420-3427, 2019 07.
Article in English | MEDLINE | ID: mdl-31087545

ABSTRACT

BACKGROUND: Pancreatic cancer is projected to become the second leading cause of cancer-related deaths by 2030. Endoscopic retrograde cholangiopancreatography (ERCP) is recommended as first-line therapy for biliary decompression in pancreatic cancer. The aim of our study was to characterize geographic and racial/ethnic disparities in ERCP utilization among patients with pancreatic cancer. METHODS: Retrospective cohort study using the US Surveillance, Epidemiology, and End Results (SEER)-Medicare database to identify patients diagnosed with pancreatic cancer from 2003-2013. The primary outcome was receipt of ERCP, with or without stent placement, vs any non-ERCP biliary intervention. RESULTS: Of the 36 619 patients with pancreatic cancer, 37.5% (n = 13 719) underwent an ERCP, percutaneous drainage, or surgical biliary bypass. The most common biliary intervention (82.6%) was ERCP. After adjusting for tumor location and stage, Blacks were significantly less likely to receive ERCP than Whites (aOR 0.84, 95% CI 0.72, 0.97) and more likely to receive percutaneous transhepatic biliary drainage (PTBD) (aOR 1.38, 95% CI 1.14, 1.66). Patients in the Southeast and the West were more likely to receive ERCP than those in the Northeast (Southeast aOR 1.21, 95% CI 1.04, 1.40; West aOR 1.16, 95% CI 1.01, 1.32). CONCLUSION: Racial/ethnic and geographic disparities in access to biliary interventions including ERCP exist for patients with pancreatic cancer in the United States. Our results highlight the need for further research and policies to improve access to appropriate biliary intervention for all patients.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Pancreatic Neoplasms/diagnosis , Pancreatic Neoplasms/epidemiology , Practice Patterns, Physicians' , Cholangiopancreatography, Endoscopic Retrograde/methods , Female , Geography , Healthcare Disparities , Humans , Male , Retrospective Studies , SEER Program , United States/epidemiology
8.
Gastrointest Endosc ; 89(5): 977-983.e2, 2019 05.
Article in English | MEDLINE | ID: mdl-30465770

ABSTRACT

BACKGROUND AND AIMS: Markedly increased liver chemistries in patients presenting with acute calculous cholecystitis (AC) often prompt an evaluation for concomitant choledocholithiasis (CDL). However, current guidelines directing the workup for CDL fail to address this unique population. The aims of this study are to define the range of presenting laboratory values and imaging findings in AC, develop a model to predict the presence of concurrent CDL, and develop a management algorithm that can be easily applied on presentation. METHODS: We conducted a retrospective review of patients presenting with AC to a large tertiary hospital over a 3.5-year period. CDL was defined as common bile duct (CBD) stone(s), sludge, or debris seen on any of the following studies: US, CT, magnetic resonance imaging/MRCP, EUS, ERCP, or intraoperative cholangiogram. A multivariable model to predict CDL was developed on 70% of the patients and validated on the remaining 30%. RESULTS: A total of 366 patients were identified and 65 (17.8%) had concurrent CDL. Univariable analysis was used to predict CDL and demonstrated statistically significant odds ratios for transaminases >3 times the upper limit of normal, alkaline phosphatase (AlkPhos) above normal, lipase >3 times the upper limit of normal, total bilirubin ≥1.8 mg/dL, and CBD diameter >6 mm. In the validation cohort, an optimal model containing alanine transaminase (ALT) >3 times the upper limit of normal, abnormal AlkPhos, and CBD diameter >6 mm was found to have an area under the receiver operating curve of 0.91. When 0 or 1 risk factors were present, 98.6% of patients did not have CDL. When all 3 risk factors were present, 77.8% were found to have CDL. CONCLUSIONS: The prevalence of CDL is high among patients with AC. When a validated model is used, application of cutoffs for ALT, AlkPhos, and CBD diameter can effectively triage patients with low and high likelihood for CDL to surgery or ERCP, respectively.


Subject(s)
Cholecystectomy/methods , Cholecystitis, Acute/diagnostic imaging , Cholecystitis, Acute/epidemiology , Choledocholithiasis/epidemiology , Choledocholithiasis/surgery , Academic Medical Centers , Adult , Age Factors , Aged , Algorithms , Analysis of Variance , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/methods , Cholangiopancreatography, Magnetic Resonance/methods , Cholecystectomy/adverse effects , Cholecystitis, Acute/surgery , Choledocholithiasis/diagnostic imaging , Cohort Studies , Comorbidity , Female , Humans , Liver Function Tests , Logistic Models , Male , Middle Aged , Multivariate Analysis , Predictive Value of Tests , Preoperative Care/methods , Prognosis , Retrospective Studies , Risk Assessment , Severity of Illness Index , Sex Factors , Treatment Outcome , United States
9.
Gastroenterol Res Pract ; 2018: 8237824, 2018.
Article in English | MEDLINE | ID: mdl-30057601

ABSTRACT

GOAL: To prospectively assess physician recommendations for repeat colonoscopy in an average-risk screening cohort. BACKGROUND: Endoscopists' adherence to colorectal cancer screening and surveillance guidelines for repeat colonoscopy have not been well characterized. Furthermore, little is known about patient and colonoscopy factors that are associated with endoscopists' nonadherence to guideline recommendation. STUDY: This is a prospective cohort of average-risk patients undergoing colonoscopy for colorectal cancer screening between August 2011 and January 2013. The primary outcome was assessment of physician recommendations for repeat colonoscopy. RESULTS: 462 participants were prospectively enrolled. 13.6% (62) had guideline-inconsistent recommendations. 89% of the guideline-inconsistent recommendations were for an earlier interval. Endoscopists' reports cited suboptimal bowel preparation as the most common reason for earlier repeat colonoscopy. On multivariable analysis, patient split-dose preparation noncompliance was significantly associated with guideline-inconsistent recommendation (OR = 2.7) even after adjusting for other patient or bowel preparation-related characteristics. Additionally, increased odds of guideline-inconsistent recommendation were associated with older age (>70 years old), higher BMI, having 3 or more polyps, having had at least two previous colonoscopies, suboptimal bowel preparation, and having taken at least 12 hours till clear bowel movement. CONCLUSIONS: Gastroenterologists are adherent to CRC screening and surveillance guidelines. Suboptimal bowel preparation is the most frequently cited factor in endoscopy reports leading to deviation from guidelines. Continued emphasis on optimization of bowel preparation, particularly patient compliance to split-dose regimen, is needed.

11.
Clin Gastroenterol Hepatol ; 16(6): 862-869.e3, 2018 06.
Article in English | MEDLINE | ID: mdl-29432922

ABSTRACT

BACKGROUND & AIMS: Barrett's esophagus (BE) is a precursor to esophageal adenocarcinoma (EAC). Guidelines recommend that patients with nondysplastic BE (NDBE) undergo surveillance endoscopy every 3-5 years. We aimed to identify factors associated with surveillance endoscopy of patients with NDBE and identify trends in appropriate surveillance endoscopy of NDBE at a large tertiary care center. METHODS: We performed a retrospective analysis of data from a Barrett's Esophagus Registry, identifying patients with NDBE who underwent endoscopy in 2002 or later. We identified patients with NDBE and collected data on length of BE segment, esophageal lesions, demographic features, medications, histology findings, comorbidities, development of EAC, and dates of follow-up endoscopies. We defined appropriate surveillance as 3-5 years between 2nd and 3rd endoscopies, over-utilizers as patients who had less than 3 years between their 2nd and 3rd endoscopies, under-utilizers as patients who had more than 5 years between their 2nd and 3rd endoscopies; and never-surveilled as patients who never received a 2nd endoscopy. The primary outcomes were effects of patient factors, year, and referring providers on appropriateness of surveillance intervals. RESULTS: We identified 477 patients with NDBE. Only 15.9% had appropriate surveillance; 37.9% were over-utilizers 15.7% were under-utilizers and 30.4% were never surveilled. Patients were less likely to be over-surveilled if their primary care physician referred them for their 3rd endoscopy instead of a gastroenterologist (adjusted odds ratio, 0.51; 95% CI, 0.27-0.95). Male patients or those with an increased number of comorbidities were more likely to be under-surveilled or never-surveilled, whereas patients with long BE segment were more likely to be over-surveilled. CONCLUSIONS: In a retrospective analysis of data from a registry of patients with BE, we found that less than 16% receive appropriate surveillance for NDBE. A primary care provider in the same health system as the endoscopy clinic reduced risk of over-surveillance. This could reflect better coordination of care between specialists and primary care providers.


Subject(s)
Adenocarcinoma/diagnosis , Barrett Esophagus/complications , Early Detection of Cancer/statistics & numerical data , Endoscopy, Gastrointestinal/statistics & numerical data , Esophageal Neoplasms/diagnosis , Facilities and Services Utilization/statistics & numerical data , Adult , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Tertiary Care Centers
12.
Am J Gastroenterol ; 113(4): 464-479, 2018 04.
Article in English | MEDLINE | ID: mdl-29485131

ABSTRACT

Pancreatic cysts are very common with the majority incidentally identified. There are several types of pancreatic cysts; some types can contain cancer or have malignant potential, whereas others are benign. However, even the types of cysts with malignant potential rarely progress to cancer. At the present time, the only viable treatment for pancreatic cysts is surgical excision, which is associated with a high morbidity and occasional mortality. The small risk of malignant transformation, the high risks of surgical treatment, and the lack of high-quality prospective studies have led to contradictory recommendations for their immediate management and for their surveillance. This guideline will provide a practical approach to pancreatic cyst management and recommendations for cyst surveillance for the general gastroenterologist.


Subject(s)
Cystadenoma, Mucinous/diagnosis , Neuroendocrine Tumors/diagnosis , Pancreatic Cyst/diagnosis , Pancreatic Cyst/therapy , Pancreatic Intraductal Neoplasms/diagnosis , Pancreatic Neoplasms/diagnosis , Watchful Waiting , Cell Transformation, Neoplastic , Cystadenoma, Mucinous/therapy , Endoscopic Ultrasound-Guided Fine Needle Aspiration , Humans , Neuroendocrine Tumors/therapy , Pancreatic Cyst/pathology , Pancreatic Intraductal Neoplasms/therapy , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/therapy
13.
Dig Dis Sci ; 62(12): 3579-3585, 2017 12.
Article in English | MEDLINE | ID: mdl-29043592

ABSTRACT

BACKGROUND: Adenoma detection rate (ADR) and sessile serrated polyp detection rate (SSPDR) data in surveillance colonoscopy are limited. AIMS: Our aim was to determine surveillance ADR and SSPDR and identify associated predictors. METHODS: A retrospective review of subjects who underwent surveillance colonoscopy for adenoma and/or SSP at an academic center was performed. The following exclusion criteria were applied: prior colonoscopy ≤ 3 years, incomplete examination, or another indication for colonoscopy. Patient, endoscopist, and procedure characteristics were collected. Predictors were identified using multivariable logistic regression. RESULTS: Of 3807 colonoscopies, 2416 met inclusion criteria. Surveillance ADR was 49% and, SSPDR was 8%. Higher ADR was associated with: age per year (OR 1.03; 95% CI 1.02-1.04), male gender (OR 1.55; 95% CI 1.29-1.88), BMI per kg/m2 (OR 1.02; 95% CI 1.01-1.04), withdrawal time per minute (OR 1.09; 95% CI 1.07-1.10), and endoscopists' screening ADR (OR 1.01; 95% CI 1.00-1.03). Years since training (OR 0.99; 95% CI 0.98-0.99) was associated with lower ADR. Family history of CRC (OR 1.58; 95% CI 1.02-2.27) and endoscopists' screening ADR (OR 1.40; 95% CI 1.15-1.74) were associated with higher SSPDR. African-American race (OR 0.36; 95% CI 0.10-0.75) and diabetes (OR 0.41; 95% CI 0.21-0.76) were associated with lower SSPDR. CONCLUSIONS: For surveillance colonoscopy, nearly half of patients had an adenoma and one in twelve had an SSP. In addition to established factors, BMI, endoscopists' screening ADR, and years since training were associated with ADR, whereas African-American race and diabetes were inversely associated with SSPDR. Further studies are needed prior to integrating surveillance ADR and SSPDR into quality metrics.


Subject(s)
Adenocarcinoma/diagnosis , Adenoma/diagnosis , Colonic Neoplasms/diagnosis , Colonic Polyps/diagnosis , Colonoscopy/statistics & numerical data , Adenocarcinoma/epidemiology , Adenoma/epidemiology , Aged , Colonic Neoplasms/epidemiology , Colonic Polyps/epidemiology , Female , Humans , Male , Michigan/epidemiology , Middle Aged , Retrospective Studies
14.
Dig Dis Sci ; 62(9): 2464-2471, 2017 09.
Article in English | MEDLINE | ID: mdl-28600656

ABSTRACT

BACKGROUND: Endoscopic experience is known to correlate with outcomes of endoscopic mucosal resection (EMR), particularly complete resection of the polyp tissue. Whether specialist endoscopists can protect against incomplete polypectomy in the setting of known risk factors for incomplete resection (IR) is unknown. AIMS: We aimed to characterize how specialist endoscopists may help to mitigate the risk of IR of large sessile polyps. METHODS: This is a retrospective cohort study of patients who underwent EMR at the University of Michigan from January 1, 2006, to November 15, 2015. The primary outcome was endoscopist-reported polyp tissue remaining at the end of the initial EMR attempt. Specialist endoscopists were defined as endoscopists who receive tertiary referrals for difficult colonoscopy cases and completed at least 20 EMR colonic polyp resections over the study period. RESULTS: A total of 257 patients with 269 polyps were included in the study. IR occurred in 40 (16%) cases. IR was associated with polyp size ≥ 40 mm [adjusted odds ratio (aOR) 3.31, 95% confidence interval (CI) 1.38-7.93], flat/laterally spreading polyps (aOR 2.61, 95% CI 1.24-5.48), and difficulty lifting the polyp (aOR 11.0, 95% CI 2.66-45.3). A specialist endoscopist performing the initial EMR was protective against IR, even in the setting of risk factors for IR (aOR 0.13, 95% CI 0.04-0.41). CONCLUSIONS: IR is associated with polyp size ≥ 40 mm, flat and/or laterally spreading polyps, and difficulty lifting the polyp. A specialist endoscopist initiating the EMR was protective of IR.


Subject(s)
Colonic Polyps/surgery , Endoscopic Mucosal Resection/methods , Endoscopic Mucosal Resection/trends , Specialization/trends , Aged , Cohort Studies , Colonic Polyps/diagnosis , Female , Follow-Up Studies , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors
15.
Gastrointest Endosc ; 86(4): 595-599, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28153570

ABSTRACT

BACKGROUND AND AIMS: Despite a paucity of women occupying leadership positions in academic medicine, studies have shown a higher ratio of female representation in the program director position compared with division chief in multiple specialties. This study aims to determine whether this trend exists in 3-year gastroenterology fellowships in the United States and to evaluate for any factors that may affect these differences. METHODS: In 2015, data were collected for the 163 U.S. gastroenterology fellowship programs including program director, associate program director, division chief, gender distribution, program size, academic center affiliation, and geographic region. RESULTS: A higher percentage of men than women held the role of program director (82% vs 18%), associate program director (72% vs 28%), and division chief (93% vs 7%). Women in program leadership held lower academic rank than their male counterparts (P < .0001). The program director was more likely to be female if the division chief also was female (P = .03). Programs with a higher number of trainees tended to be led by a female program director (P = .06). CONCLUSIONS: A gender disparity exists in all gastroenterology leadership roles, although the magnitude is smaller for program director and associate program director than the role of division chief. Further studies are needed to investigate the impact of this disparity on promotion and academic productivity.


Subject(s)
Faculty, Medical/statistics & numerical data , Fellowships and Scholarships , Gastroenterology/education , Leadership , Physicians, Women/statistics & numerical data , Female , Humans , Male , United States
16.
Gastroenterology ; 152(5): 1002-1013.e9, 2017 04.
Article in English | MEDLINE | ID: mdl-28012848

ABSTRACT

BACKGROUND & AIMS: Many cancers in the proximal colon develop via from sessile serrated adenomas (SSAs), which have flat, subtle features that are difficult to detect with conventional white-light colonoscopy. Many SSA cells have the V600E mutation in BRAF. We investigated whether this feature could be used with imaging methods to detect SSAs in patients. METHODS: We used phage display to identify a peptide that binds specifically to SSAs, using subtractive hybridization with HT29 colorectal cancer cells containing the V600E mutation in BRAF and Hs738.St/Int cells as a control. Binding of fluorescently labeled peptide to colorectal cancer cells was evaluated with confocal fluorescence microscopy. Rats received intra-colonic 0.0086 mg/kg, 0.026 mg/kg, or 0.86 mg/kg peptide or vehicle and morbidity, mortality, and injury were monitored twice daily to assess toxicity. In the clinical safety study, fluorescently labeled peptide was topically administered, using a spray catheter, to the proximal colon of 25 subjects undergoing routine outpatient colonoscopies (3 subjects were given 2.25 µmol/L and 22 patients were given 76.4 µmol/L). We performed blood cell count, chemistry, liver function, and urine analyses approximately 24 hours after peptide administration. In the clinical imaging study, 38 subjects undergoing routine outpatient colonoscopies, at high risk for colorectal cancer, or with a suspected unresected proximal colonic polyp, were first evaluated by white-light endoscopy to identify suspicious regions. The fluorescently labeled peptide (76.4 µmol/L) was administered topically to proximal colon, unbound peptide was washed away, and white-light, reflectance, and fluorescence videos were recorded digitally. Fluorescence intensities of SSAs were compared with those of normal colonic mucosa. Endoscopists resected identified lesions, which were analyzed histologically by gastrointestinal pathologists (reference standard). We also analyzed the ability of the peptide to identify SSAs vs adenomas, hyperplastic polyps, and normal colonic mucosa in specimens obtained from the tissue bank at the University of Michigan. RESULTS: We identified the peptide sequence KCCFPAQ and measured an apparent dissociation constant of Kd = 72 nM and an apparent association time constant of K = 0.174 min-1 (5.76 minutes). During fluorescence imaging of patients during endoscopy, regions of SSA had 2.43-fold higher mean fluorescence intensity than that for normal colonic mucosa. Fluorescence labeling distinguished SSAs from normal colonic mucosa with 89% sensitivity and 92% specificity. The peptide had no observed toxic effects in animals or patients. In the analysis of ex vivo specimens, peptide bound to SSAs had significantly higher mean fluorescence intensity than to hyperplastic polyps. CONCLUSIONS: We have identified a fluorescently labeled peptide that has no observed toxic effects in animals or humans and can be used for wide-field imaging of lesions in the proximal colon. It distinguishes SSAs from normal colonic mucosa with 89% sensitivity and 92% specificity. This targeted imaging method might be used in early detection of premalignant serrated lesions during routine colonoscopies. ClinicalTrials.gov ID: NCT02156557.


Subject(s)
Adenoma/pathology , Colonic Neoplasms/pathology , Colonic Polyps/pathology , Adenoma/diagnostic imaging , Adenoma/genetics , Aged , Aged, 80 and over , Animals , Cell Line, Tumor , Colonic Neoplasms/diagnostic imaging , Colonic Neoplasms/genetics , Colonic Polyps/diagnostic imaging , Colonic Polyps/genetics , Colonoscopy , Esophagoscopy , Female , Fluorescein-5-isothiocyanate , Fluorescent Dyes , HT29 Cells , Humans , Male , Microscopy, Confocal , Microscopy, Fluorescence , Middle Aged , Optical Imaging , Proto-Oncogene Proteins B-raf/genetics , Rats
17.
Surg Endosc ; 31(9): 3489-3494, 2017 09.
Article in English | MEDLINE | ID: mdl-27928667

ABSTRACT

BACKGROUND: Esophageal fully covered self-expandable metal stents (FCSEMS) are indicated for the management of benign and malignant conditions of the esophagus including perforations, leaks, and strictures. FCSEMS are resistant to tissue ingrowth and are removable; however, stent migration occurs in 30-55% of cases. Endoscopic suture fixation of FCSEMS has been utilized to decrease the risk of stent migration though data supporting this practice remain limited. The primary aim of this study was to compare clinical outcomes and migration rate of patients who underwent placement of esophageal FCSEMS with and without endoscopic suture fixation. METHODS: Our single-center, retrospective, cohort study includes patients who underwent esophageal FCSEMS placement with and without endoscopic suture fixation between January 1, 2012, and November 11, 2015. Baseline patient characteristics, procedural details, and clinical outcomes were abstracted. Logistic regression was performed to identify clinical and technical factors associated with outcomes and stent migration. RESULTS: A total of 51 patients underwent 62 FCSEMS placements, including 21 procedures with endoscopic suture fixation and 41 without. Suture fixation was associated with reduced risk of stent migration (OR 0.13, 95% CI 0.03-0.47). Prior stent migration was associated with significantly higher risk of subsequent migration (OR 6.4, 95% CI 1.6-26.0). Stent migration was associated with lower likelihood of clinical success (OR 0.21, 95% CI 0.06-0.69). There was a trend toward higher clinical success among patients undergoing suture fixation (85.7 vs. 60.9%, p = 0.07). CONCLUSIONS: Endoscopic suture fixation of FCSEMS was associated with a reduced stent migration rate. Appropriate patient selection for suture fixation of FCSEMS may lead to reduced migration in high-risk patients.


Subject(s)
Esophagoscopy , Foreign-Body Migration/prevention & control , Self Expandable Metallic Stents , Suture Techniques , Adult , Aged , Female , Humans , Logistic Models , Male , Middle Aged , Retrospective Studies , Treatment Outcome
19.
Dig Dis Sci ; 61(11): 3155-3160, 2016 11.
Article in English | MEDLINE | ID: mdl-27487794

ABSTRACT

BACKGROUND: Trainees learn colonoscopy skills at varying speeds. We hypothesized that a fellow's ability to reliably reach the splenic flexure early in training could predict the number of procedures required to achieve competency in intubating the cecum. METHODS: This was a retrospective analysis of prospectively collected data. The most proximal site in the colon reached independently by GI fellows was recorded on consecutive colonoscopies. The number of procedures required to achieve splenic flexure intubation rate (SFIR) ≥ 90 % by cumulative summation learning curve and cecal intubation rate (CIR) ≥ 90 % by rolling average was calculated. Fellows were then dichotomized into "Early" versus "Late" learners based on the median number of procedures required to achieve SFIR ≥ 90 %. The number of procedures required to achieve CIR ≥ 90 % was then compared between the groups. RESULTS: Fellows achieved SFIR ≥ 90 % at a median of 37 colonoscopies. Fellows who achieved SFIR competency early achieved CIR ≥ 90 % at a mean of 208 procedures versus 352 procedures in the fellows who achieved SFIR competency late (p = 0.03). CONCLUSIONS: Data from a single academic medical center show that whether a trainee will learn endoscopy quickly compared to his/her peers can be predicted early in their endoscopy training by tracking SFIR. This knowledge could be used to customize endoscopy curriculum.


Subject(s)
Colonoscopy/education , Fellowships and Scholarships , Gastroenterology/education , Learning Curve , Cecum , Clinical Competence , Colon, Transverse , Humans , Retrospective Studies
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