AIMTo assess the efficacy of CO2 insufflation for reduction of mediastinal emphysema (ME) immediately after endoscopic submucosal dissection (ESD).
METHODSA total of 46 patients who were to undergo esophageal ESD were randomly assigned to receive either CO2 insufflation (CO2 group, n = 24) or air insufflation (Air group, n = 22). Computed tomography (CT) was carried out immediately after ESD and the next morning. Pain and abdominal distention were chronologically recorded using a 100-mm visual analogue scale (VAS). The volume of residual gas in the digestive tract was measured using CT imaging.
RESULTSThe incidence of ME immediately after ESD in the CO2 group was significantly lower than that in the Air group (17% vs 55%, P = 0.012). The incidence of ME the next morning was 8.3% vs 32% respectively (P
ORIGINAL ARTICLE
Randomized Controlled TrialCarbon dioxide insufflation in esophageal endoscopic submucosal dissection reduces mediastinal emphysema: A randomized, double-blind, controlled trial after esophageal ESD with CO2 insufflation [8] . To further assess the efficacy of CO2 insufflation for reduction of post-ESD ME, we conducted a prospective, doubleblind, randomized controlled trial, the results of which are reported herein.
MATERIALS AND METHODS
Study designThis study was a single-center, randomized, doubleblind, controlled trial in Japan. This study was approved by the institutional review board of Sendai City Medical Center and met all criteria of the Declaration of Helsinki. The trial was registered with the UMIN Clinical Trials Registry (No. UMIN000006441).
ParticipantsBetween February 2011 and May 2012, all consecutive patients undergoing esophageal ESD at the center were screened for recruitment. The inclusion criterion was all consecutive patients undergoing esophageal ESD. The following patients were excluded: those who had severe chronic obstructive pulmonary disease (COPD) resulting in less than 50% of the predicted values of the forced expiratory volume in 1 s (FEV1.0) or less than 70% of FEV1.0/FVC (forced vital capacity) [12] , those who had experienced CO2 retention, those who had multiple synchronous esophageal lesions treated at one time, those who were to undergo esophageal ESD under general anesthesia with positive pressure ventilation, and those who refused to participate. All participants provided written informed consent prior to enrollment in the study.
Randomization and blindingParticipants were randomly assigned to either the CO2 insufflation group (CO2 group) or the air insufflation group (Air group). Randomization took place immediately before the ESD procedure. Individual randomization to the two treatment groups (1:1) was performed by using computer-generated random numbers. A sequentially numbered, opaque, sealed envelope containing a random number was opened sequentially by an endoscopy nurse after participant details were written on the envelope. When the number was even, the patient was allocated to the CO2 group and administration of CO2 was started. When the n...