Phase II study of percutaneous transesophageal gastrotubing for patients with malignant gastrointestinal obstruction; JIVROSG-0205.

PURPOSE: This multicenter, prospective study was conducted to evaluate the efficacy of percutaneous transesophageal gastrotubing (PTEG) as an esophagostomy procedure for bowel decompression in patients with malignant bowel obstruction. MATERIALS AND METHODS: The study subjects were patients with malignant bowel obstruction treated with a nasogastric tube (NGT). After receiving PTEG, efficacy evaluations were conducted, with NGT designated as the control state. The procedure was considered effective only when discomfort in the nasopharynx was improved for at least 2 weeks. Safety was evaluated by using National Cancer Institute Common Toxicity Criteria, version 2.0. PTEG was performed by using a PTEG kit. RESULTS: From February 2003 to December 2005, 33 patients were enrolled. The technical success rate was 100%, and the procedure was considered effective in 30 of 33 cases. The three cases in which the procedure was ineffective could not be evaluated as a result of deterioration of general status or early death. The one recorded complication was a tracheoesophageal fistula that caused grade 2 aspiration pneumonia. CONCLUSIONS: PTEG is an effective technique to relieve discomfort in the nasopharynx caused by NGT in patients with terminal malignant tumors. PTEG should be considered an efficacious method for bowel decompression in patients who are ineligible for surgical procedures, percutaneous gastrostomy, or percutaneous enterostomy.