OBJECTIVE: To compare the tolerance, feasibility, and safety of ultrathin esophagogastroduodenoscopy (EGD) in unsedated patients with conventional EGD in sedated patients.
STUDY DESIGN: This was an unblinded, randomized controlled trial.
POPULATION: Diagnostic EGD was performed on 72 adult outpatients at a US Air Force community hospital residency. Patients were randomized to either ultrathin or conventional EGD (n = 33 and 39, respectively).
OUTCOMES MEASURED: Patients reported their tolerance of the procedure (pain, choking, gagging, and anxiety; scale 0–10), and the endoscopist reported the effectiveness of the procedure (successful intubation, reaching duodenum, retroflexion, and duration of examination and recovery) and safety (complications).
RESULTS: No statistically significant difference was noted between the 2 groups in mean procedure time or pain during the procedure. Mean (± standard error) recovery time was approximately halved in the ultrathin group vs the conventional group (21.5 ± 2.3 min vs 55.4 ± 2.3 min, P < .0001). Although patients undergoing ultrathin EGD had higher mean gagging and choking scores, they had lower mean anxiety scores. Of 33 patients randomized to the unsedated ultrathin EGD procedure, 29 completed the protocol. The retroflexion maneuver was completed in 85% of patients in the ultrathin EGD group and 100% of patients in the conventional EGD group (P = .017). No statistically significant difference was noted between groups as to the likelihood of reaching the second portion of the duodenum (97% vs 100%).
CONCLUSIONS: Most patients tolerate ultrathin EGD with significantly shorter recovery time and less overall anxiety than with the conventioanl procedure. Techniques to reduce gagging and choking associated with ultrathin EGD may improve patient acceptance and tolerability. Adoption of ultrathin EGD by primary care physicians may decrease cost, time, and inconvenience while increasing access to EGD for many patients.
- Most patients tolerate unsedated, ultrathin esophagogastroduodenoscopy (EGD).
- The recovery time is approximately halved for ultrathin unsedated EGDs.
- Patients undergoing unsedated EGD report more gagging and choking than do patients having the sedated examination.
- Patients receiving sedated upper endoscopy report more anxiety than those receiving an unsedated examination.
- Once credentialed in upper endoscopy, physicians do not require further training or skills to perform ultrathin EGD.
Hacker et al1 reported that 3 times as many patients prefer esophagogastroduodenoscopy (EGD) to upper gastrointestinal roentgenography. EGD is safe, with complication rates between 5 and 10 per 10,000 procedures.2 However, only 2% of US family physicians perform upper endoscopy.3
In the United States, conventional EGD is usually performed under conscious sedation to reduce discomfort and anxiety.4 Conscious sedation has potential negative aspects, including costs and side effects,5 increased risks of respiratory depression,2 and, very rarely, mortality.5 Indirect costs related to lost work are unmeasured. All these factors may decrease patient tolerance or acceptance of conventional EGD with conscious sedation.
In the last decade, an ultrathin (5.3–5.9 mm diameter) fiberoptic endoscope was developed. Shaker et al6 used an ultrathin endoscope to perform transnasal endoscopy of the gastrointestinal tract. Since then, several prospective studies have evaluated ultrathin EGD.7-9 One study compared ultrathin with conventional EGD, although both groups of subjects were unsedated.10 Studies comparing EGD techniques were performed in large medical centers by gastroenterologists.7-17 The purpose of this study was to assess the feasibility, safety, and patient tolerance of unsedated ultrathin EGD by generalists in a community setting.
Methods
Outpatients (aged 20–80 years) from a US Air Force family practice residency were referred to a family practice endoscopist for further evaluation of dyspepsia, heartburn, and epigastric pain. Exclusion criteria included pregnancy, evidence of acute gastrointestinal hemorrhage, potential need for therapeutic endoscopy, a medically unstable patient (eg, recent myocardial infarction or stroke), coagulopathy, unstable angina, severe chronic obstructive pulmonary disease, and severe aortic stenosis. The local institutional review board approved the study.
An Olympus GIF-N230 gastrointestinal videoscope (Olympus America Inc, Melville, NY) with an outer diameter of 6.0 mm, an accessory channel of 2.0 mm, a working length of 122 cm, tip deflection of 180° (up and down) and 160° (right and left), with a field of view of 120° was used for the ultrathin procedures. An Olympus GIF-130 standard gastroscope (Olympus America Inc) with an outer diameter of 9.8 mm, an accessory channel of 2.8 mm, a working length of 103 cm, tip deflection of 210° up, 90° down, and 100° right and left, with a field of view of 120°, was used for the conventional procedures. Both endoscopes are forward-viewing (Figure 1).
After standard informed consent was obtained, the endoscopist made a phone call to access a computer-generated patient list for randomization. No patient withdrew after randomization. The endoscopist (T.W.) performed all endoscopies in the gastrointestinal suite with the patient in the left lateral position. An intravenous line was started and tetracaine 2% was sprayed in the posterior pharynx; pulse oximetry, cardiac monitoring, and verbal reassurance by the endoscopist were provided to patients in both groups. Sedation was slowly titrated in increments of 25 mg meperidine (or 50 mg fentanyl if the patient was allergic to meperidine) and 0.5 mg midazolam until a suitable level of sedation was obtained for endoscopy. Biopsy samples were obtained when indicated. Patients who were unable to tolerate the unsedated examination were given intravenous sedation, and the examination was completed using ultrathin EGD.