MULTICENTER, RANDOMIZED CONTROLLED TRIAL OF LONG TUBE VERSUS NASOGASTRIC TUBE WITH WATER-SOLUBLE CONTRAST AGENT FOR SMALL BOWEL OBSTRUCTION
Takahito Katano*1, Takaya Shimura1, Hirotada Nishie1, Tomohiro Iwai2, Keisuke Itoh3, Masahide Ebi4, Yusuke Mizuno5, Shozo Togawa6, Shunsuke Shibata2, Tomonori Yamada5, Takashi Mizushima7, Yusuke Inagaki8, Shuji Takiguchi9, Hiromi Kataoka1
1Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Please Select, Japan; 2Toyokawa City Hospital, Toyokawa, Japan; 3Nagoya City East medical Center, Nagoya, Japan; 4Aichi Medical University, Nagakute, Japan; 5Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan; 6Nagoya Memorial Hospital, Nagoya, Japan; 7Gifu Prefectural Tajimi Hospital, Tajimi, Japan; 8Gamagori City Hospital, Gamagori, Japan; 9Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Background: Gastrointestinal decompression is applied to small bowel obstruction (SBO) without any findings of strangulation and ischemia. Decompression with nasogastric tube (NGT) is a standard treatment for SBO in Western countries based on an old small randomized controlled trial (RCT) that showed no significant differences between NGT and long tube (LT). On the other hand, decompression with LT is a standard procedure in Eastern Asian countries due to its superiority to NGT alone in a recent large Asian RCT. Some studies have reported that administration of water-soluble contrast, Gastrografin, through NGT (NGT-G) is more effective treatment for SBO than NGT alone. However, there have been no comparative studies between LT and NGT-G. We thus conducted a RCT to evaluate the efficacy of NGT-G for patients with SBO.
Methods: In this multicenter, open label, randomized controlled trial, patients with SBO from 11 Japanese institutions were randomly assigned by a computer-based randomization to receive LT or NGT-G between July 2016 and November 2018. Patients who assigned to the NGT-G group could receive LT placement appropriately, when SBO is not improved over 24 h. The primary end point was non-inferiority of NGT-G to LT for non-surgery rate. Based on the results of previous studies, 95.3% CI lower limit of -15% non-surgery rate would be accepted as a lower margin for inferiority with NGT-G to LT. Pre-planned sample size was 220 overall 1-sided-α and β errors of 0.025 and 0.20.
Results: In total, 224 patients with SBO were enrolled to this trial and 223 patients after exclusion of 1 consent withdrawal were finally analyzed including 111 patients in the LT group and 112 patients in the NGT-G group. Baseline characteristics were well balanced between 2 groups. Non-surgery rate without non-surgical management was 87.4% in the LT group and 91.1% in the NGT-G group, and difference between LT and NGT-G was 3.7% (95.3% CI; -5.55 to 12.91; non-inferiority P= 0.00002923). Among 112 patients in the NGT-G group, 86 patients improved by NGT-G alone (76.8%), 16 patients did by NGT-G followed by LT and 10 patients underwent surgery. Non-surgery rate of NGT-G alone was significantly lower than LT (P=0.039).
Expectedly, median insertion time was much shorter in the NGT-G group than in the LT group (1 min vs. 25 min; P= 0.0001). No significant differences were found for relief time of abdominal symptoms and duration of hospitalization between 2 groups. In the LT and NGT-G arms, adverse event rates ≥ grade 4 were 4.5% and 0.9% (P=0.119) and mortality rates were 0.91% and 0% (P>0.999), respectively.
Conclusion: NGT-G is an effective alternative to LT as the first-line treatment for SBO. Sequential strategy, NGT-G followed by LT, might be a novel standard treatment for SBO.
(University Hospital Medical Network Clinical Trials Registry, Number: UMIN000022669)
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