A randomized, controlled trial of the efficacy of percutaneous transesophageal gastro-tubing (PTEG) as palliative care for patients with malignant bowel obstruction: the JIVROSG0805 trial
A randomized, controlled trial to evaluate the superiority of percutaneous transesophageal gastro-tubing over nasogastric tubing as palliative care for bowel obstruction in patients with terminal malignancy was conducted.
Subjects and methods
The subjects were patients with malignant bowel obstruction with no prospect of improvement, for whom surgery was not indicated and with a Palliative Prognostic Index of < 6. They were randomly allocated in a 1:1 ratio to receive either percutaneous transesophageal gastro-tubing (PTEG group) or nasogastric tubing (NGT group). Their symptom scores (the worst 0 to no symptoms 10) were measured for a 2-week period after enrollment, and the areas under the curves for the two groups were compared. The EQ-5D and SF-8 were also used to assess overall quality of life.
Forty patients were enrolled between October 2009 and January 2015, with 21 allocated to the PTEG group and 19 to the NGT group. The mean areas under the curves (95% confidence intervals) for the PTEG group and the NGT groups were 149.6 (120.3–178.8) and 44.9 (16.4–73.5), respectively, significantly higher for the NGT group (p < 0.0001). The secondary endpoints of quality of life as assessed by the EQ-5D and SF-8 scores were also significantly higher for patients in the PTEG group (p = 0.0036, p = 0.0020). There was no difference in survival between the groups. No serious adverse events were observed.
In terms of quality of life, percutaneous transesophageal gastro-tubing was superior to nasogastric tubing as palliative care for patients with bowel obstruction due to terminal malignancy.
KeywordsPercutaneous transesophageal gastro-tubing Malignant bowel obstruction Palliative medicine Quality of life Randomized controlled trial
The authors are grateful to their patients and the staff of all participating institutions.
Funding from the Japan Agency for Medical Research and Development (AMED) [16ck0106058h0003 to Y.A.], the Ministry of Health, Labour and Welfare of Japan [H26-055 to Y.A.], and the National Cancer Center Research and Development Fund [26-A-27 to M.S.] is gratefully acknowledged.
Compliance with ethical standards
Conflict of interest
Y.A. Speaker’s Bureau from Guerbet Japan, Kyorin Pharma, Canon Medical Systems and Fuji Pharma, Royalty from Sumitomo Bakelite, and Advisor fee from Japan Lifeline.
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