Krefeld CONTRA study: conventional peroral Esophago-Gastro-Duodenoscopy (EGD) vs. transnasal EGD--a prospective and randomised study with independent evaluation of conscious sedation, endoscope diameter, and access path.

Background: The guidelines of the German Gastroenterology Society (Deutsche Gesellschaft fur Verdauungs- und Stoffwechselkrankheiten, DGVS) demand the presence of an additional qualified person solely responsible for patient monitoring during sedated endoscopy. Transnasal esophagogastroduodenoscopy (EGD) allows easy access to the upper gastrointestinal tract and may avoid the complications induced by conscious sedation and reduce medical costs. Patient and Method: 120 patients referred to diagnostic EGD were assigned to six groups: group 1, unsedated peroral EGD with normal-caliber endoscope ; group 2, unsedated peroral EGD with small-caliber endoscope; group 3, sedated peroral EGD with normal-caliber endoscope; group 4, sedated peroral EGD with small-caliber endoscope; group 5, unsedated transnasal EGD with small-caliber endoscope; group 6, sedated transnasal EGD with small-caliber endoscope. Outcome parameters included objective (duration, oxygen saturation) and subjective measures (standardised visual analogue scales) of the endoscopy staff (handling, insertion, retroflexion, tolerability, overall assessment) and patients (pain, unpleasantness, sore throat, choking, gagging, meteorism, anxiety, acceptability). Results: The patients were comparable according to age, sex, anxiety, and respiratory function before EGD. Sedoanalgesia was without effect on EGD handling and duration, patient tolerability and overall assessment by endoscopists and assistants. Negative effects of sedoanalgesia (decreased oxygen saturation, patient acceptability) were much lower and without significance for transnasal compared to peroral EGD. Patient tolerability and acceptability of the endoscopic staff (handling, insertion, retroflexion) were significantly better for the small-caliber endoscope. Duration of unsedated transnasal EGD was slightly but significantly longer, pain, unpleasantness, and anxiety slightly but significantly higher compared to sedated peroral EGD. However, these differences could no loner be detected seven days after endoscopy. Cost analysis revealed major advantage for transnasal EGD. Conclusion: Unsedated transnasal EGD may replace diagnostic peroral EGD, reduces costs with acceptable patient discomfort and has advantagous acceptability of the endoscopic staff.