A double-blind, block-randomized, placebo-controlled trial to identify the chemical assistance effect of mesna submucosal injection for gastric endoscopic submucosal dissection.
BACKGROUND
Previous animal studies and a pilot clinical trial demonstrated that submucosal injection of a thiol compound called mesna could chemically soften connective tissues and thus facilitate endoscopic submucosal dissection (ESD).


OBJECTIVE
To evaluate whether mesna injection could reduce procedural times for gastric ESD.


METHODS
Double-blind, block-randomized, controlled trial.


METHODS
University hospital.


METHODS
A total of 101 patients with superficial gastric cancer indicated for ESD were enrolled and randomly assigned to either the mesna or control (saline solution) group.


METHODS
Traditional ESD was performed with a single bolus injection of mesna or saline solution.


METHODS
Time for submucosal dissection (TSD).


RESULTS
En bloc resection was achieved for all lesions in the mesna group (53/53) and 51 of 52 lesions (98.08%) in the control group. TSD was not statistically different between the groups (18.62 ± 13.9 [mean ± SD] minutes for the mesna group and 24.58 ± 24.55 [mean ± SD] minutes for the control group; P = .128), and there were fewer time-consuming cases (times over 30 minutes) in the mesna group compared with controls (7/53 vs 15/52; P = .049). Multivariate regression analysis demonstrated that use of mesna, specimen size, and the presence of fibrous scars were significantly correlated with TSD (P < .05).


CONCLUSIONS
Single-center study.


CONCLUSIONS
TSD was not significantly different between the mesna and control injection groups, but multivariate analysis indicated that mesna injection reduced procedural challenges associated with the submucosal dissection. (


BACKGROUND
UMIN000003786.).
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
Kazuki
K
Sumiyama
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
Hirobumi
H
Toyoizumi
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
Tomohiko R
TR
Ohya
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
Akira
A
Dobashi
Department of Neuropsychiatry, Ishikawa Prefectural Takamatsu Hospital, Ishikawa, Japan.
Shoryoku
S
Hino
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan; Department of Internal Medicine, Division of Gastroenterology and Hepatology, The Jikei University School of Medicine, Tokyo, Japan.
Masakuni
M
Kobayashi
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
Kenichi
K
Goda
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
Hiroo
H
Imazu
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
Yumi
Y
Kawakita
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
Tomohiko
T
Kato
Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan; Department of Internal Medicine, Division of Gastroenterology and Hepatology, The Jikei University School of Medicine, Tokyo, Japan.
Hisao
H
Tajiri
D002921:Cicatrix / Q000150:complications; D004210:Dissection / Q000009:adverse effects / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005753:Gastric Mucosa / Q000601:surgery*; D005773:Gastroscopy; D006801:Humans; D008297:Male; D015080:Mesna / Q000008:administration & dosage*; D061646:Operative Time; D020011:Protective Agents / Q000008:administration & dosage*; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*
D020011:Protective Agents; D015080:Mesna