Proton pump inhibitor after endoscopic resection for esophageal squamous cell cancer: multicenter prospective randomized controlled trial.
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.


CONCLUSIONS
PPI therapy is not efficacious in reducing symptoms and did not promote healing of ulcers in patients undergoing ER for ESCC.
Division of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Suntougun, Shizuoka, 4118777, Japan. kakushin-tky@umin.ac.jp.
N
N
Kakushima
Kyoto University Graduate School of Medicine, Kyoto, Japan.
K
K
Hori
Division of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Suntougun, Shizuoka, 4118777, Japan.
H
H
Ono
Kyoto University Graduate School of Medicine, Kyoto, Japan.
T
T
Horimatsu
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
N
N
Uedo
NTT Medical Center Tokyo, Tokyo, Japan.
K
K
Ohata
Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.
H
H
Doyama
National Cancer Center East, Chiba, Japan.
K
K
Kaneko
National Cancer Center, Tokyo, Japan.
I
I
Oda
Fukushima Medical University, Fukushima, Japan.
T
T
Hikichi
Okayama University Hospital, Okayama, Japan.
Y
Y
Kawahara
The University of Tokyo Graduate School of Medicine, Tokyo, Japan.
K
K
Niimi
Fukuoka University Chikushi Hospital, Fukuoka, Japan.
Y
Y
Takaki
Hiroshima City Hospital, Hiroshima, Japan.
M
M
Mizuno
Kitano General Hospital, Osaka, Japan.
S
S
Yazumi
Toyama University Hospital, Toyama, Japan.
A
A
Hosokawa
Mitoyo General Hospital, Kanonji, Kagawa, Japan.
A
A
Imagawa
Kyoto University Graduate School of Medicine, Kyoto, Japan.
M
M
Niimi
Kobe University School of Medicine, Kobe, Japan.
K
K
Yoshimura
Kyoto University Graduate School of Medicine, Kyoto, Japan.
M
M
Muto
D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000601:surgery*; D004935:Esophageal Diseases / Q000188:drug therapy / Q000209:etiology; D004938:Esophageal Neoplasms / Q000473:pathology / Q000601:surgery*; D000077277:Esophageal Squamous Cell Carcinoma; D004945:Esophagoscopy / Q000009:adverse effects* / Q000379:methods; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000209:etiology; D006356:Heartburn / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D010149:Postoperative Pain / Q000188:drug therapy / Q000209:etiology; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014456:Ulcer / Q000188:drug therapy / Q000209:etiology
D054328:Proton Pump Inhibitors
Endoscopic resection; Esophageal cancer; Gastroesophageal reflux disease; Proton pump inhibitor; Squamous cell cancer