The “pre-procedure” time period includes the points of contact pertaining to the upper endoscopy that occur between the patient and the endoscopy team prior to the delivery of sedation. In chronological order, this often begins with the initial consultation between the patient and his or her endoscopist, during which time an appropriate indication for upper endoscopy is identified and the upper endoscopy is suggested. A discussion and documentation of informed consent must occur during the pre-procedure period. Depending on the practice setting and framework within which the physician practices, this may be performed in detail at the time of the initial evaluation, on the day of the procedure, or a combination of both. In the modern practice of gastroenterology, many upper endoscopic examinations are performed in an “open-access” manner, with the endoscopist meeting the patient on the day of the procedure.

It is imperative that the upper endoscopy be performed by an appropriately trained and credentialed individual and that the following items are documented in the patient chart: a directed/focused history and physical, assessment of the patient’s procedure-related risks, discussion of the timing of the upper endoscopy (which often immediately follows the history in the open-access setting), sedation plan, and pre-procedure preparation (including management of medications such as anticoagulants and antibiotics). Finally, immediately prior to the upper endoscopy, the performance of a “time-out” should be performed and documented [3, 6].

Generally speaking, medical and surgical procedures are indicated when diagnostic information is obtainable and/or the therapeutic potential of the procedure will improve the patient’s outcome. Conversely, medical and surgical procedures are not indicated when the risks associated with them outweigh any perceived benefit [6]. For gastrointestinal endoscopy, the ASGE Standards of Practice Committee initially published a list of appropriate indication for endoscopic procedures in 2000 [10] and updated this list in 2012 [11]. Practicing endoscopists should familiarize themselves with this and future updated versions of this ASGE document. Of particular note, upper GI endoscopy is generally not indicated for routine surveillance of healed benign disease (excluding premalignant conditions) and is generally contraindicated when adequate patient cooperation or consent cannot be obtained or when a perforated viscus is known or suspected unless the purpose of the endoscopy is to close the perforation itself [12].

The ASGE/ACG Task force suggests that providers achieve this quality indicator (i.e., frequency with which upper endoscopy is performed for an appropriate indication) using a “performance target” over 80% and recommends that appropriate indication(s) are documented for each procedure, justifying the use of any nonstandard indication(s) in the medical record as well [6]. Studies have demonstrated that significantly more clinically relevant findings are obtained when GI endoscopy is performed for appropriate indications. This applies to both colonoscopy [13] and EGD [14]. As such, an important quality improvement goal of every endoscopist should be minimization or elimination of procedures without appropriate indications.

Multiple training and credentialing guidelines have been published by the ASGE regarding the basic levels of competency and credentialing required to perform endoscopy. These emphasize the importance of using objective measures of an endoscopist’s performance, in particular comparing performance to validated benchmarks (whenever possible). Ideally, competency for all endoscopists, regardless of subspecialty (e.g., GI and surgery), should be measured with comparable validated benchmarks, thereby establishing and documenting an endoscopist’s ability to perform, at a minimum, the therapeutic interventions specific to a given endoscopic procedure. A high-quality upper endoscopy is one which is performed by an endoscopist who has met objective measures for competency whereby the desired objectives have been met and the potential for adverse events are minimized [6, 15–17].

The initial ASGE guidelines on informed consent for GI endoscopy were published in 1988 [18] and have since been updated, calling for a performance target (i.e., frequency with which informed consent is obtained and documented) exceeding 98% [6, 19]. According to these guidelines, the burden of legally obtaining adequate informed consent from the patient lies with the endoscopist prior to performing the endoscopic procedure [19]. If the patient is unable to consent due to incompetence or incapacitation, then their legal guardian or surrogate must consent on their behalf.

In the USA, the process of obtaining informed consent legally requires that the physician discloses information to the patient, enabling the patient to understand the procedure, evaluate the risks, benefits, and alternatives, and authorize a specific intervention [20]. Two standards of disclosure exist, and endoscopists are required to learn the applicable standard in the state they practice in.

The “physician-based” standard requires that the endoscopist discloses to the patient the amount of information that a reasonable, similarly situated endoscopist would. On the other hand, the “reasonable patient” standard requires the endoscopist to provide information that a reasonable layperson would consider material and significant when consenting to a proposed intervention [19].

It is prudent for an endoscopist to consult with the legal team within the confines of their practice setting when determining the informed consent standard they should use, the informed consent documentation they should complete, and the appropriateness of any audiovisual aides they may wish to use to facilitate the informed consent process.

In general terms, information regarding the indication, risks, benefits, alternatives, limitations, and personnel that will be involved in the endoscopic procedure should be disclosed. Patients should be aware of what occurs before, during, and after the procedure. Medications that are likely to be administered should be discussed with the patient. If an anesthesiology team will be present to deliver the sedation or anesthesia, a separate consent should be obtained by the anesthesia provider. It is not possible to anticipate and disclose every conceivable risk or complication of an invasive procedure; efforts should, therefore, focus on substantial risks that would influence a reasonable person’s willingness to consent for a procedure. Reasonable alternatives to the endoscopy should be discussed, including those that may be more invasive or carry a riskier adverse event profile. Patients should also be counseled if no alternative exists and of the potential outcomes of declining endoscopy [19].

While informed consent is almost always necessary, there are four recognized exceptions to obtaining informed consent for surgical procedures. The clinical situations in which these are evoked are generally rare, especially as they relate to the performance of upper endoscopy. The first exception is when the patient has a life-threatening emergency with inadequate time available to obtain consent. Another exception is the invocation of therapeutic privilege: when the physician determines that providing the patient information would harm the patient. The third exception is when the patient, while knowledgeable and understanding of their right to informed consent, waives that right in writing. The final exception is the presence of a legal mandate in the form of a court order or statute where the patient’s and/or public’s welfare may overshadow the informed consent process [19].

The ASGE/ACG Task force and the American Society of Anesthesiologists (ASA) recommend that a pre-procedure assessment be documented prior to endoscopic procedures [6]. This documentation typically includes pertinent clinical history, medications, allergies, adverse reactions to prior anesthetics or sedatives, history of substance use or abuse, time of last oral intake, and a directed physical examination. Various organizations that accredit hospital endoscopy centers and ambulatory surgical centers, as well as third-party payors, may stipulate that this information be documented independent of the endoscopic procedure report. Endoscopists should familiarize themselves with local and institutional requirements and protocols for the documentation of the pre-procedure history and physical examination. The task force recommends a performance target over 98% for successful completion of the required documentation [6].

Before sedation is administered, an assessment of potential adverse events associated with sedation should be performed and documented in the chart, based on the information gathered during focused history and physical examination discussed in the previous section [6]. Patients should be risk-stratified based on their individual ASA and Mallampati scores [6, 21], and the information obtained should be considered in the decision-making process regarding the endoscopic procedure. The Mallampati score assesses the upper airway using a visual scale in which an increasing score correlates with increasing difficulty encountered during endotracheal intubation. The ASA score takes into account a patient’s comorbidities and ranks them on a scale from 1 to 6 (Table 14.1). The use of the ASA scoring system has been shown to predict adverse events related to sedation in endoscopy [22]. The ASGE/ACG Task force recommends a performance target over 98% for the documentation of risk assessment prior to endoscopy [6].

The ASGE/ACG Task force recommends a performance target over 98% for the formulation of a sedation plan prior to endoscopy. In the USA, upper endoscopy is typically performed with moderate sedation (also known as conscious sedation), deep sedation, or under general anesthesia. Rarely, upper endoscopy can be performed without sedation, often with the use of transnasal ultrathin endoscopes.

Moderate sedation is often delivered by an endoscopy nurse under the supervision and direction of the endoscopist. Moderate sedation involves administration of certain drugs to induce depression of consciousness to a degree in which patients are able to respond purposefully to verbal commands with or without light tactile stimulation. In moderate sedation, the patient is able to independently maintain a patent airway as well as maintain cardiovascular function [6].

Deep sedation and general anesthesia are typically administered by the anesthesia team that works in conjunction with the endoscopy team. Deep sedation is a drug-induced depression of consciousness to a degree in which patients cannot be easily aroused but can respond purposefully after repeated or painful stimulation. In deep sedation, a patient’s ability to independently maintain their ventilator function may become impaired and they may require assistance maintaining a patent and protected airway. Cardiovascular function, on the other hand, is usually maintained under deep sedation. General anesthesia is a drug-induced loss of consciousness during which patients cannot be aroused, even by painful stimulation. Under general anesthesia, a patient’s ability to independently maintain their ventilatory function is frequently impaired and they frequently require ventilator support. Furthermore, cardiovascular function may be impaired during general anesthesia [6].

Multiple medications that patients may be receiving prior to the day of upper endoscopy are of particular relevance and decisions regarding whether to continue or temporarily discontinue them must be considered on a case-by-case basis, guided by on the patient’s history, indication for the upper endoscopy, and timing of the proposed procedure. A few examples of important medication-related pre-endoscopy decisions that occur frequently in clinical practice include whether to hold or continue any of the broad array of currently available antithrombotic therapies that many patients are receiving, when to administer prophylactic antibiotic therapy (e.g., endoscopy for PEG tube placement or endoscopy in the cirrhotic patient with acute upper GI bleeding),the use of vasoactive drugs prior to EGD for patients with suspected variceal bleeding, and the use of proton pump inhibitor (PPI) therapy when peptic ulcer bleeding is suspected.

Antithrombotic therapy includes antiplatelet agents as well as anticoagulant agents that are used to reduce the risk of thromboembolic events in patients with various cardiac, hematologic, neurologic, and vascular conditions such as embolic cerebrovascular accident, atrial fibrillation, venous thromboembolic disease, acute coronary syndrome, hypercoagulable conditions, and the presence of various indwelling endoprostheses. There has been significant development of novel pharmacotherapeutics over the last decade, and endoscopists should familiarize themselves with the recent ASGE Standards of Practice Committee guidelines which include recommendations for the management of these medications in the peri-procedural period [23].

Generally, diagnostic upper endoscopy is considered low risk for causing procedure-related bleeding, and the cessation of antithrombotic therapy is not routinely warranted. Some therapeutic upper endoscopic procedures, however, are considered high risk for procedure-related bleeding and may require cessation of certain antithrombotic medications. Patients at high risk for thromboembolic adverse events include those with atrial fibrillation associated with other specific cardiac conditions or a history of thromboembolism, mechanical mitral valve, coronary artery stents placed within one year in the setting of acute coronary syndrome, or non-stented percutaneous coronary intervention after myocardial infarction. Such patients may require consultation with their cardiologist, initiation of bridge therapy, or deferment of endoscopic evaluation until a management plan is established [6]. Of note, in many cases, endoscopy can be performed while maintaining antithrombotic or antiplatelet medication usage.

Most diagnostic upper endoscopic procedures can be performed safely without discontinuing aspirin prior to the procedure, and most patients can and should continue to take aspirin following their upper endoscopy. Patients who undergo certain endoscopic therapies, however, may require temporary cessation of antithrombotic therapy. Reinitiation of antithrombotic therapy in this group of patients should be individualized based on the type of endoscopic therapy they received and their individual risk of thromboembolism. The ASGE/ACG Task force recommends that antithrombotic medication use by the patient be recorded and that a plan regarding peri-procedural management of antithrombotic medications is both documented and communicated to the patient and the healthcare team [6].

Prophylactic antibiotics are indicated prior to upper endoscopy with PEG tube placement [24], and their use should be discussed with the patient in the informed consent and documented in the medical record [19]. Antibacterial agents that cover cutaneous sources of bacterial infection, such as cefazolin, should be administered to patients undergoing PEG tube placement 30 min prior to the procedure (unless a contraindication to the use of cephalosporins exists or there is a high level of suspicion for cephalosporin-resistant organisms based on the patients prior to bacteriologic history and/or regional antimicrobial resistance patters) [24–26]. The ASGE/ACG Task force recommends a performance target over 98% for the administration of prophylactic antibiotic therapy prior to PEG tube placement [3].

Prophylactic antibiotics are indicated in patients with cirrhosis and acute upper GI bleeding. Oral fluoroquinolones or intravenous ceftriaxone should be administered independent of performing an upper endoscopy with the latter group of antibiotics reserved for patients with advanced cirrhosis, inability to take oral medications or in areas with high fluoroquinolone resistance [27–29]. The ASGE/ACG Task force has identified the frequency with which appropriate prophylactic antibiotics are given in this setting to be a “priority” quality indicator and recommends a performance target over 98% (priority indicators were selected from among all of the indicators discussed because of their clinical relevance and importance, evidence that significant variability exists in how frequently (or infrequently) the indicator is performed in clinical practice, and the feasibility of measuring the indicator) [3].