Informed consent for endoscopic procedures: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

All endoscopic procedures are invasive and carry risk. Accordingly, all endoscopists should involve the patient in the decision-making process about the most appropriate endoscopic procedure for that individual, in keeping with a patient's right to self-determination and autonomy. Recognition of this has led to detailed guidelines on informed consent for endoscopy in some countries, but in many no such guidance exists; this may lead to variations in care and exposure to risk of litigation. In this document, the European Society of Gastrointestinal Endoscopy (ESGE) sets out a series of statements that cover best practice in informed consent for endoscopy. These statements should be seen as a minimum standard of practice, but practitioners must be aware of and adhere to the law in their own country. 1: Patients should give informed consent for all gastrointestinal endoscopic procedures for which they have capacity to do so. 2: The healthcare professional seeking consent for an endoscopic procedure should ensure that the patient has the capacity to consent to that procedure. 3: For patients who lack capacity, healthcare personnel should at all times try to engage with people close to the patient, such as family, friends, or caregivers, to achieve consensus on the appropriateness of performing the procedure. 4: Where a patient lacks capacity to provide informed consent, the best interest decision should be clearly documented in the medical record. This should include information about the capacity assessment, reason(s) that the decision cannot be delayed for capacity recovery (or if recovery is not expected), who has been consulted, and where relevant the form of authority for the decision. 5: There should be a systematic and transparent disclosure of the expected benefits and harms that may reasonably affect patient choice on whether or not to undergo any diagnostic or interventional endoscopic procedure. Information about possible alternatives, as well as the consequences of doing nothing, should also be provided when relevant. 6: The information provided on the benefit and harms of an endoscopic procedure should be adapted to the procedure and patient-specific risk factors, and the preferences of the patient should be central to the consent process. 7: The consent discussion should be undertaken by an individual who is familiar with the procedure and its risks, and is able to discuss these in the context of the individual patient. 8: Patients should confirm consent to an endoscopic procedure in a private, unrushed, and non-coercive environment. 9: If a patient requests that an endoscopic procedure be discontinued, the procedure should be paused and the patient's capacity for decision making assessed. If a competent patient continues to object to the procedure, or if a conclusive determination of capacity is not feasible, the examination should be terminated as soon as it is safe to do so. 10: Informed consent should be sufficiently detailed to cover all findings that can be reasonably anticipated during an endoscopic examination. The scope of this consent should not be expanded, nor a patient's implicit consent for additional interventions assumed, unless failure to proceed with such interventions would result in immediate and predictable harm to the patient.

Management of code status in the periendoscopic period: a national survey of current practices and beliefs of U.S. gastroenterologists.

BACKGROUND AND AIMS: This study aims to assess current practices and perspectives of gastroenterologists on approaches to code status before inpatient endoscopy. METHODS: Self-reported data were obtained through a voluntary, anonymous survey of gastroenterologists and gastroenterology trainees in the United States. The survey assessed respondents' approach to, beliefs, and knowledge regarding inpatient periprocedural code status discussions. RESULTS: Four hundred thirty-six gastroenterologists and 83 trainees completed the survey. For patients with an existing do not resuscitate (DNR) order, respondents reversed the code status before endoscopy either all (40.8%, n = 212) or most of the time (18.3%, n = 95). When asked their personal opinion, 32.6% (n =169) supported automatic DNR reversal to full resuscitation attempt during a procedure, 18.5% (n = 96) supported that DNR orders could be sustained, and 48.7% (n = 253) supported offering limited resuscitation. Many gastroenterologists were unaware of institutional (40.7%, n = 211) or national (80.7%, n = 419) policies, and a majority reported that a gastroenterology-specific guideline would be helpful (88.6%, n = 460). CONCLUSIONS: Although most of the gastroenterologists reverse DNR orders more than 75% of the time before endoscopy, many also believe patients should be allowed to remain DNR during a procedure and supported a third option for limited resuscitation. Most gastroenterologists were unaware of institutional policies or existing national guidelines. These findings suggest considerable variation in knowledge and current approaches regarding periendoscopic code status reversal.

A novel self-propelled disposable colonoscope is effective for colonoscopy in humans (with video).

BACKGROUND AND AIMS: The self-propelled disposable colonoscope (SPDC) with a 360° view is designed to enhance visualization, minimize risks of perforation and infection transmission, and shorten operator training time associated with conventional colonoscopy (CC). We evaluated SPDC efficacy for cecal intubation and safety. METHODS: Prospective patients presenting for colorectal cancer screening underwent SPDC immediately followed by CC. Initial patients necessary for SPDC operators to achieve proficiency comprised the training cohort. Subsequent enrolled patients comprised the study cohort. SPDC colonoscopy was performed up to the cecum, where anatomic landmarks were photographed and mucosal suction marks were placed. During SPDC withdrawal, polyps were recorded and similarly marked. On the second pass (by using CC), any potential mucosal damage and suction marks from the SPDC as well as polyps were recorded. Main endpoints included SPDC cecal intubation rates, confirmed by anatomic landmarks and residual marks seen on subsequent CC, and frequency and severity of adverse events and mucosal damage with SPDC. The secondary endpoint was subjective procedure proficiency, evaluated by the operator based on the training cohort. The tertiary endpoint was documenting pathologies visualized with SPDC. RESULTS: Fifty-six of 58 enrolled subjects completed the study. Proficiency with SPDC was attained after 8 to 10 procedures. Cecal intubation was successful in 98.2% (55/56 subjects; 95% confidence interval [CI], 90.4%-99.9%), including 100% (95% CI, 90.7%-100%) of the study cohort and 94.4% (95% CI, 72.7%-99.9%) of the training cohort. No mucosal damage or adverse events were reported. SPDC detected 87.5% of polyps seen in tandem CC, including all polyps larger than 5 mm. CONCLUSIONS: SPDC was highly successful, simple to use, and safe in achieving complete colonoscopy (cecal intubation). ( CLINICAL TRIAL REGISTRATION NUMBER: 0692-12-TLV.).

A multicenter, prospective, randomized comparison of a novel signal transmission capsule endoscope to an existing capsule endoscope.

BACKGROUND: MiroCam, a capsule endoscope, uses a novel transmission technology, electric-field propagation, which uses the human body as a conduction medium for data transmission. OBJECTIVE: To compare the ability of the MiroCam (MC) and PillCam (PC) to identify sources of obscure GI bleeding (OGIB). DESIGN: Prospective, multicenter, comparative study. SETTING: Six academic hospitals. PATIENTS: A total of 105 patients with OGIB. INTERVENTION: Patients ingested both the MC and PC capsules sequentially in a randomized fashion. MAIN OUTCOME MEASUREMENTS: Concordance of rates in identifying a source of OGIB, operational times, and rates of complete small-bowel examination. RESULTS: Data analysis resulted in 43 (48%) "abnormal" cases identifying a source of OGIB by either capsule. Twenty-four cases (55.8%) were positive by both capsules. There was negative agreement in 46 of 58 cases (79.3%). The κ index was 0.547 (χ(2) = 1.32; P = .36). In 12 cases, MC positively identified a source that was not seen on PC, whereas in 7 cases, PC positively identified a source that was not seen on MC. MC had a 5.6% higher rate of detecting small-bowel lesions (P = .54). MC captured images at 3 frames per second for 11.1 hours, and PC captured images at 2 frames per second for 7.8 hours (P < .0001). Complete small-bowel examination was achieved in 93.3% for MC and 84.3% for PC (P = .10). LIMITATIONS: Readers were not blinded to the particular capsule they were reading. CONCLUSION: A positive diagnostic finding for OGIB was identified by either capsule in 48% of cases. The concordance rate between the 2 capsules was comparable to that of prior studies in identifying sources of small-bowel bleeding. The longer operational time of the MC may result in higher rates of complete small-bowel examination, which may, in turn, translate into a higher rate of detecting small-bowel lesions. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00878982.).

Complications of endoscopic and radiologic investigation of biliary tract disorders.

The investigation and treatment of disorders of the human biliary tree depend considerably on invasive endoscopic and radiologic procedures. These are associated with a significant risk of complications, some of which can be fatal. This review looks at these complications through the lens of 40 years of publications in the medical literature, and identifies the strengths and weaknesses of their current classification, diagnosis, and treatment.

The Future of Endoscopic Operations After the Coronavirus Pandemic.

The unprecedented COVID-19 pandemic and its rapid global shutdowns have posed tremendous challenges for GI practices, including sudden delays in endoscopic procedures. As full reopening approaches, practices are wrestling with completely retooling their operations to ensure the resumption of high-quality, safe, and effective patient care. The pandemic's long-term effects on practice operations must be assessed: What will postpandemic GI care look like? Will some aspects of our work be changed forever, and if so, what are the practice management implications? This chapter surveys the pandemic's impact on US-based GI practices and discusses key "lessons learned" for future operations.

A multicenter randomized comparison of the Endocapsule and the Pillcam SB.

BACKGROUND: Video capsule endoscopy has been shown to be the single most effective endoscopic procedure for identifying the source of obscure GI bleeding (OGIB). OBJECTIVE: Our purpose was to report on the Food and Drug Administration pivotal trial in which the Endocapsule (EC) (Olympus America, Allentown, Pa) was compared with the Pillcam SB (PSB) (Given Imaging, Yoqneam, Israel) in patients with OGIB. DESIGN: A novel trial design was used in which the EC and the PSB were swallowed by the same patient 40 minutes apart, in randomized order. SETTING: Four academic medical centers. PATIENTS: Patients with OGIB aged 18 to 85 years who had either been transfused or who had a hematocrit of <31% in males or <28% in females. INTERVENTIONS: Both video capsules were swallowed in random order. Videos from the PSB were read locally for patient management. All videos were then read by at least 2 independent readers for normal versus abnormal categorization, a diagnosis, capsule transit time, reading time, and a subjective assessment of image quality. MAIN OUTCOME MEASUREMENT: Categorization of videos as either normal or abnormal. RESULTS: Data from 51 of 63 enrolled patients were analyzed. Nine patients were excluded for technical reasons and 3 for protocol violations. Twenty-four videos were read as normal and 14 as abnormal from both capsules. Disagreement occurred in 13. No adverse events were reported for either capsule. Overall agreement was 38 of 51 (74.5%) with a kappa of 0.48, P = .008. LIMITATIONS: Although ingestion order was randomized, the videos could not be read blind owing to a different shape of the image margin. CONCLUSIONS: (1) Both devices were safe and had a comparable diagnostic yield within the range previously reported. (2) There was a subjective difference in image quality favoring the EC. (3) This study design provided unique information about capsule movement in the small intestine and the lack of electromechanical interference between 2 different capsules.

Defining and measuring endoscopic complications: more questions than answers.

The demand for information on quality in health care has risen sharply over the past decade. Endoscopic outcomes, including complication rates, need to be accurately measured and reported. Such documentation continues to be problematic because of the lack of a widely accepted classification system for endoscopic complications. Such a system should (1) include unequivocal definitions for the various types of negative outcomes and categories of complications; (2) define what negative outcomes are to be classified as complications, and (3) standardize the stratification of complications by severity. Establishing such a standardized classification of endoscopic complications could facilitate clinical research, improve the position of gastroenterologists vis-à-vis pay-for-performance programs, and result in better and more meaningful quality improvement programs, ultimately improving the care provided to patients.

Current procedural terminology, Resource-based Relative Value Scale, and the Center for Medicare and Medicaid Services: overview.

Coding and payment methodology for physician professional services has been standardized through the introduction of the Current Procedural Terminology, which is maintained by the American Medical Association. The codes contained within this dataset are used by health care professionals to describe their services to payers. Inherent in the development of the procedural codes, the Resource Based Relative Value Scale Update Committee recommends physician work relative value units and practice expense and professional liability inputs to the Center for Medicare and Medicaid Services. This article provides an overview of the processes in place that permit regular updates in physician payment continually to be updated.

Frequently asked coding questions.

Current Procedural Terminology (CPT) coding is not an exact science. Although the CPT code set was developed to describe clearly and comprehensively services provided by health care professionals, the intended application of individual codes is not always clear. In addition, coding that may be correct in terms of CPT definitions and instructions may contradict instructions from payment policies set by insurers. This article provides answers to the gastroenterologists' most commonly asked questions and provides primary sources for coding and payment policies when possible. Answers to the questions are accurate as of the date of publication but may be subject to change.

Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study.

BACKGROUND: Screening improves outcomes related to colorectal cancer (CRC); however, suboptimal participation for available screening tests limits the full benefits of screening. Non-invasive screening using a blood based assay may potentially help reach the unscreened population. OBJECTIVE: To compare the performance of a new Septin9 DNA methylation based blood test with a fecal immunochemical test (FIT) for CRC screening. DESIGN: In this trial, fecal and blood samples were obtained from enrolled patients. To compare test sensitivity for CRC, patients with screening identified colorectal cancer (n = 102) were enrolled and provided samples prior to surgery. To compare test specificity patients were enrolled prospectively (n = 199) and provided samples prior to bowel preparation for screening colonoscopy. MEASUREMENTS: Plasma and fecal samples were analyzed using the Epi proColon and OC Fit-Check tests respectively. RESULTS: For all samples, sensitivity for CRC detection was 73.3% (95% CI 63.9-80.9%) and 68.0% (95% CI 58.2-76.5%) for Septin9 and FIT, respectively. Specificity of the Epi proColon test was 81.5% (95% CI 75.5-86.3%) compared with 97.4% (95% CI 94.1-98.9%) for FIT. For paired samples, the sensitivity of the Epi proColon test (72.2% -95% CI 62.5-80.1%) was shown to be statistically non-inferior to FIT (68.0%-95% CI 58.2-76.5%). When test results for Epi proColon and FIT were combined, CRC detection was 88.7% at a specificity of 78.8%. CONCLUSIONS: At a sensitivity of 72%, the Epi proColon test is non- inferior to FIT for CRC detection, although at a lower specificity. With negative predictive values of 99.8%, both methods are identical in confirming the absence of CRC. TRIAL REGISTRATION: ClinicalTrials.gov NCT01580540.