Proton pump inhibitor after endoscopic resection for esophageal squamous cell cancer

multicenter prospective randomized controlled trial

N. Kakushima, K. Hori, H. Ono, T. Horimatsu, N. Uedo, K. Ohata, H. Doyama, K. Kaneko, I. Oda, T. Hikichi, Yoshiro Kawahara, K. Niimi, Y. Takaki, M. Mizuno, S. Yazumi, A. Hosokawa, A. Imagawa, M. Niimi, K. Yoshimura, M. Muto

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Whether proton pump inhibitors (PPIs) relieve heartburn or precordial pain after endoscopic resection (ER) for esophageal squamous cell carcinoma (ESCC) remains unclear. The aim of this study was to investigate the efficacy of PPI therapy for these symptoms after ER for ESCC. Methods: We conducted a multicenter prospective randomized controlled trial among 15 hospitals in Japan. In total, 229 patients with cT1a ESCC were randomly assigned to receive PPI therapy for 5 weeks after ER (the PPI group, n = 115) or follow-up without PPI therapy (the non-PPI group, n = 114). The primary end point was the incidence of gastroesophageal reflux disease (GERD)-like symptoms after ER from a self-reported questionnaire (Frequency Scale for Symptoms of GERD). Secondary end points were ulcer healing rate at 5 weeks, incidence of pain, improvement rate of symptoms in those who started PPI therapy because of GERD-like symptoms in the non-PPI group, and adverse events. Results: No significant difference was observed in the incidence of GERD-like symptoms after ER between the non-PPI and PPI groups (30 % vs 34 %, respectively). No significant differences were observed in the ulcer healing rate at 5 weeks (84 % vs 85 %) and incidence of pain within 1 week (36 % vs 45 %). In nine of ten patients (90 %) who started PPI therapy because of GERD-like symptoms in the non-PPI group, PPI administration relieved GERD-like symptoms. No adverse events related to PPI administration were observed. Conclusion: PPI therapy is not efficacious in reducing symptoms and did not promote healing of ulcers in patients undergoing ER for ESCC.

Original languageEnglish
Pages (from-to)104-111
Number of pages8
JournalJournal of Gastroenterology
Volume51
Issue number2
DOIs
Publication statusPublished - Feb 1 2016

Fingerprint

Squamous Cell Neoplasms
Proton Pump Inhibitors
Esophageal Neoplasms
Randomized Controlled Trials
Gastroesophageal Reflux
Ulcer
Incidence
Pain
Proton Therapy
Therapeutics
Heartburn
Japan

Keywords

  • Endoscopic resection
  • Esophageal cancer
  • Gastroesophageal reflux disease
  • Proton pump inhibitor
  • Squamous cell cancer

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Proton pump inhibitor after endoscopic resection for esophageal squamous cell cancer : multicenter prospective randomized controlled trial. / Kakushima, N.; Hori, K.; Ono, H.; Horimatsu, T.; Uedo, N.; Ohata, K.; Doyama, H.; Kaneko, K.; Oda, I.; Hikichi, T.; Kawahara, Yoshiro; Niimi, K.; Takaki, Y.; Mizuno, M.; Yazumi, S.; Hosokawa, A.; Imagawa, A.; Niimi, M.; Yoshimura, K.; Muto, M.

In: Journal of Gastroenterology, Vol. 51, No. 2, 01.02.2016, p. 104-111.

Research output: Contribution to journalArticle

Kakushima, N, Hori, K, Ono, H, Horimatsu, T, Uedo, N, Ohata, K, Doyama, H, Kaneko, K, Oda, I, Hikichi, T, Kawahara, Y, Niimi, K, Takaki, Y, Mizuno, M, Yazumi, S, Hosokawa, A, Imagawa, A, Niimi, M, Yoshimura, K & Muto, M 2016, 'Proton pump inhibitor after endoscopic resection for esophageal squamous cell cancer: multicenter prospective randomized controlled trial', Journal of Gastroenterology, vol. 51, no. 2, pp. 104-111. https://doi.org/10.1007/s00535-015-1085-9
Kakushima, N. ; Hori, K. ; Ono, H. ; Horimatsu, T. ; Uedo, N. ; Ohata, K. ; Doyama, H. ; Kaneko, K. ; Oda, I. ; Hikichi, T. ; Kawahara, Yoshiro ; Niimi, K. ; Takaki, Y. ; Mizuno, M. ; Yazumi, S. ; Hosokawa, A. ; Imagawa, A. ; Niimi, M. ; Yoshimura, K. ; Muto, M. / Proton pump inhibitor after endoscopic resection for esophageal squamous cell cancer : multicenter prospective randomized controlled trial. In: Journal of Gastroenterology. 2016 ; Vol. 51, No. 2. pp. 104-111.
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abstract = "Background: Whether proton pump inhibitors (PPIs) relieve heartburn or precordial pain after endoscopic resection (ER) for esophageal squamous cell carcinoma (ESCC) remains unclear. The aim of this study was to investigate the efficacy of PPI therapy for these symptoms after ER for ESCC. Methods: We conducted a multicenter prospective randomized controlled trial among 15 hospitals in Japan. In total, 229 patients with cT1a ESCC were randomly assigned to receive PPI therapy for 5 weeks after ER (the PPI group, n = 115) or follow-up without PPI therapy (the non-PPI group, n = 114). The primary end point was the incidence of gastroesophageal reflux disease (GERD)-like symptoms after ER from a self-reported questionnaire (Frequency Scale for Symptoms of GERD). Secondary end points were ulcer healing rate at 5 weeks, incidence of pain, improvement rate of symptoms in those who started PPI therapy because of GERD-like symptoms in the non-PPI group, and adverse events. Results: No significant difference was observed in the incidence of GERD-like symptoms after ER between the non-PPI and PPI groups (30 {\%} vs 34 {\%}, respectively). No significant differences were observed in the ulcer healing rate at 5 weeks (84 {\%} vs 85 {\%}) and incidence of pain within 1 week (36 {\%} vs 45 {\%}). In nine of ten patients (90 {\%}) who started PPI therapy because of GERD-like symptoms in the non-PPI group, PPI administration relieved GERD-like symptoms. No adverse events related to PPI administration were observed. Conclusion: PPI therapy is not efficacious in reducing symptoms and did not promote healing of ulcers in patients undergoing ER for ESCC.",
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author = "N. Kakushima and K. Hori and H. Ono and T. Horimatsu and N. Uedo and K. Ohata and H. Doyama and K. Kaneko and I. Oda and T. Hikichi and Yoshiro Kawahara and K. Niimi and Y. Takaki and M. Mizuno and S. Yazumi and A. Hosokawa and A. Imagawa and M. Niimi and K. Yoshimura and M. Muto",
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T1 - Proton pump inhibitor after endoscopic resection for esophageal squamous cell cancer

T2 - multicenter prospective randomized controlled trial

AU - Kakushima, N.

AU - Hori, K.

AU - Ono, H.

AU - Horimatsu, T.

AU - Uedo, N.

AU - Ohata, K.

AU - Doyama, H.

AU - Kaneko, K.

AU - Oda, I.

AU - Hikichi, T.

AU - Kawahara, Yoshiro

AU - Niimi, K.

AU - Takaki, Y.

AU - Mizuno, M.

AU - Yazumi, S.

AU - Hosokawa, A.

AU - Imagawa, A.

AU - Niimi, M.

AU - Yoshimura, K.

AU - Muto, M.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Background: Whether proton pump inhibitors (PPIs) relieve heartburn or precordial pain after endoscopic resection (ER) for esophageal squamous cell carcinoma (ESCC) remains unclear. The aim of this study was to investigate the efficacy of PPI therapy for these symptoms after ER for ESCC. Methods: We conducted a multicenter prospective randomized controlled trial among 15 hospitals in Japan. In total, 229 patients with cT1a ESCC were randomly assigned to receive PPI therapy for 5 weeks after ER (the PPI group, n = 115) or follow-up without PPI therapy (the non-PPI group, n = 114). The primary end point was the incidence of gastroesophageal reflux disease (GERD)-like symptoms after ER from a self-reported questionnaire (Frequency Scale for Symptoms of GERD). Secondary end points were ulcer healing rate at 5 weeks, incidence of pain, improvement rate of symptoms in those who started PPI therapy because of GERD-like symptoms in the non-PPI group, and adverse events. Results: No significant difference was observed in the incidence of GERD-like symptoms after ER between the non-PPI and PPI groups (30 % vs 34 %, respectively). No significant differences were observed in the ulcer healing rate at 5 weeks (84 % vs 85 %) and incidence of pain within 1 week (36 % vs 45 %). In nine of ten patients (90 %) who started PPI therapy because of GERD-like symptoms in the non-PPI group, PPI administration relieved GERD-like symptoms. No adverse events related to PPI administration were observed. Conclusion: PPI therapy is not efficacious in reducing symptoms and did not promote healing of ulcers in patients undergoing ER for ESCC.

AB - Background: Whether proton pump inhibitors (PPIs) relieve heartburn or precordial pain after endoscopic resection (ER) for esophageal squamous cell carcinoma (ESCC) remains unclear. The aim of this study was to investigate the efficacy of PPI therapy for these symptoms after ER for ESCC. Methods: We conducted a multicenter prospective randomized controlled trial among 15 hospitals in Japan. In total, 229 patients with cT1a ESCC were randomly assigned to receive PPI therapy for 5 weeks after ER (the PPI group, n = 115) or follow-up without PPI therapy (the non-PPI group, n = 114). The primary end point was the incidence of gastroesophageal reflux disease (GERD)-like symptoms after ER from a self-reported questionnaire (Frequency Scale for Symptoms of GERD). Secondary end points were ulcer healing rate at 5 weeks, incidence of pain, improvement rate of symptoms in those who started PPI therapy because of GERD-like symptoms in the non-PPI group, and adverse events. Results: No significant difference was observed in the incidence of GERD-like symptoms after ER between the non-PPI and PPI groups (30 % vs 34 %, respectively). No significant differences were observed in the ulcer healing rate at 5 weeks (84 % vs 85 %) and incidence of pain within 1 week (36 % vs 45 %). In nine of ten patients (90 %) who started PPI therapy because of GERD-like symptoms in the non-PPI group, PPI administration relieved GERD-like symptoms. No adverse events related to PPI administration were observed. Conclusion: PPI therapy is not efficacious in reducing symptoms and did not promote healing of ulcers in patients undergoing ER for ESCC.

KW - Endoscopic resection

KW - Esophageal cancer

KW - Gastroesophageal reflux disease

KW - Proton pump inhibitor

KW - Squamous cell cancer

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