Short-term outcomes of multicenter prospective cohort study of gastric endoscopic resection: ‘Real-world evidence’ in Japan

Ichiro Oda1 for J-WEB/EGC group

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Objectives: A Japanese multicenter prospective cohort study examining endoscopic resection (ER) for early gastric cancer (EGC) has been conducted using a Web registry developed to determine the short-term and long-term outcomes based on absolute and expanded indications. We hereby present the short-term outcomes of this study. Methods: All consecutive patients with EGC or suspected EGC undergoing ER at 41 participating institutions between July 2010 and June 2012 were enrolled and prospectively registered into the Web registry. The baseline characteristics were entered before ER, and the short-term outcomes were collected at 6 months following ER. Results: Nine thousand six hundred and sixteen patients with 10 821 lesions underwent ER (endoscopic submucosal dissection [ESD]: 99.4%). The median procedure time was 76 min, and R0 resections were achieved for 91.6% of the lesions. Postoperative bleeding and intraoperative perforation occurred in 4.4% and 2.3% of the patients, respectively. Significant independent factors correlated with a longer procedure time (120 min or longer) were as follows: tumor size >20 mm, upper-third location, middle-third location, local recurrent lesion, ulcer findings, gastric tube, male gender, and submucosa. Histopathologically, 10 031 lesions were identified as common-type gastric cancers. The median tumor size was 15 mm. Noncurative resections were diagnosed for 18.3% of the lesions. Additional surgery was performed for 48.6% (824 lesions) of the 1695 noncurative ER lesions with a possible risk of lymph node (LN) metastasis. Among them, 64 (7.8%) exhibited LN metastasis. Conclusions: This multicenter prospective study showed favorable short-term outcomes for gastric ESD.

Original languageEnglish
JournalDigestive Endoscopy
DOIs
Publication statusAccepted/In press - Jan 1 2018

Fingerprint

Stomach Neoplasms
Stomach
Japan
Cohort Studies
Prospective Studies
Registries
Lymph Nodes
Neoplasm Metastasis
Stomach Ulcer
Multicenter Studies
Neoplasms
Outcome Assessment (Health Care)
Hemorrhage
Endoscopic Mucosal Resection

Keywords

  • early gastric cancer
  • endoscopic resection
  • multicenter prospective study
  • real-world evidence
  • short-term outcome

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Short-term outcomes of multicenter prospective cohort study of gastric endoscopic resection : ‘Real-world evidence’ in Japan. / Ichiro Oda1 for J-WEB/EGC group.

In: Digestive Endoscopy, 01.01.2018.

Research output: Contribution to journalArticle

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title = "Short-term outcomes of multicenter prospective cohort study of gastric endoscopic resection: ‘Real-world evidence’ in Japan",
abstract = "Objectives: A Japanese multicenter prospective cohort study examining endoscopic resection (ER) for early gastric cancer (EGC) has been conducted using a Web registry developed to determine the short-term and long-term outcomes based on absolute and expanded indications. We hereby present the short-term outcomes of this study. Methods: All consecutive patients with EGC or suspected EGC undergoing ER at 41 participating institutions between July 2010 and June 2012 were enrolled and prospectively registered into the Web registry. The baseline characteristics were entered before ER, and the short-term outcomes were collected at 6 months following ER. Results: Nine thousand six hundred and sixteen patients with 10 821 lesions underwent ER (endoscopic submucosal dissection [ESD]: 99.4{\%}). The median procedure time was 76 min, and R0 resections were achieved for 91.6{\%} of the lesions. Postoperative bleeding and intraoperative perforation occurred in 4.4{\%} and 2.3{\%} of the patients, respectively. Significant independent factors correlated with a longer procedure time (120 min or longer) were as follows: tumor size >20 mm, upper-third location, middle-third location, local recurrent lesion, ulcer findings, gastric tube, male gender, and submucosa. Histopathologically, 10 031 lesions were identified as common-type gastric cancers. The median tumor size was 15 mm. Noncurative resections were diagnosed for 18.3{\%} of the lesions. Additional surgery was performed for 48.6{\%} (824 lesions) of the 1695 noncurative ER lesions with a possible risk of lymph node (LN) metastasis. Among them, 64 (7.8{\%}) exhibited LN metastasis. Conclusions: This multicenter prospective study showed favorable short-term outcomes for gastric ESD.",
keywords = "early gastric cancer, endoscopic resection, multicenter prospective study, real-world evidence, short-term outcome",
author = "{Ichiro Oda1 for J-WEB/EGC group} and Haruhisa Suzuki and Kohei Takizawa and Toshiaki Hirasawa and Yoji Takeuchi and Kenji Ishido and Shu Hoteya and Tomonori Yano and Shinji Tanaka and Masaki Endo and Masahiro Nakagawa and Takashi Toyonaga and Hisashi Doyama and Kingo Hirasawa and Mitsuru Matsuda and Hironori Yamamoto and Mitsuhiro Fujishiro and Satoru Hashimoto and Yuki Maeda and Tsuneo Oyama and Ryuta Takenaka and Yoshinobu Yamamoto and Yuji Naito and Tomoki Michida and Nozomu Kobayashi and Yoshiro Kawahara and Masaaki Hirano and Mario Jin and Shinichiro Hori and Yasumasa Niwa and Takuto Hikichi and Taichi Shimazu and Hiroyuki Ono and Satoshi Tanabe and Hitoshi Kondo and Hiroyasu Iishi and Motoki Ninomiya",
year = "2018",
month = "1",
day = "1",
doi = "10.1111/den.13246",
language = "English",
journal = "Digestive Endoscopy",
issn = "0915-5635",
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T1 - Short-term outcomes of multicenter prospective cohort study of gastric endoscopic resection

T2 - ‘Real-world evidence’ in Japan

AU - Ichiro Oda1 for J-WEB/EGC group

AU - Suzuki, Haruhisa

AU - Takizawa, Kohei

AU - Hirasawa, Toshiaki

AU - Takeuchi, Yoji

AU - Ishido, Kenji

AU - Hoteya, Shu

AU - Yano, Tomonori

AU - Tanaka, Shinji

AU - Endo, Masaki

AU - Nakagawa, Masahiro

AU - Toyonaga, Takashi

AU - Doyama, Hisashi

AU - Hirasawa, Kingo

AU - Matsuda, Mitsuru

AU - Yamamoto, Hironori

AU - Fujishiro, Mitsuhiro

AU - Hashimoto, Satoru

AU - Maeda, Yuki

AU - Oyama, Tsuneo

AU - Takenaka, Ryuta

AU - Yamamoto, Yoshinobu

AU - Naito, Yuji

AU - Michida, Tomoki

AU - Kobayashi, Nozomu

AU - Kawahara, Yoshiro

AU - Hirano, Masaaki

AU - Jin, Mario

AU - Hori, Shinichiro

AU - Niwa, Yasumasa

AU - Hikichi, Takuto

AU - Shimazu, Taichi

AU - Ono, Hiroyuki

AU - Tanabe, Satoshi

AU - Kondo, Hitoshi

AU - Iishi, Hiroyasu

AU - Ninomiya, Motoki

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objectives: A Japanese multicenter prospective cohort study examining endoscopic resection (ER) for early gastric cancer (EGC) has been conducted using a Web registry developed to determine the short-term and long-term outcomes based on absolute and expanded indications. We hereby present the short-term outcomes of this study. Methods: All consecutive patients with EGC or suspected EGC undergoing ER at 41 participating institutions between July 2010 and June 2012 were enrolled and prospectively registered into the Web registry. The baseline characteristics were entered before ER, and the short-term outcomes were collected at 6 months following ER. Results: Nine thousand six hundred and sixteen patients with 10 821 lesions underwent ER (endoscopic submucosal dissection [ESD]: 99.4%). The median procedure time was 76 min, and R0 resections were achieved for 91.6% of the lesions. Postoperative bleeding and intraoperative perforation occurred in 4.4% and 2.3% of the patients, respectively. Significant independent factors correlated with a longer procedure time (120 min or longer) were as follows: tumor size >20 mm, upper-third location, middle-third location, local recurrent lesion, ulcer findings, gastric tube, male gender, and submucosa. Histopathologically, 10 031 lesions were identified as common-type gastric cancers. The median tumor size was 15 mm. Noncurative resections were diagnosed for 18.3% of the lesions. Additional surgery was performed for 48.6% (824 lesions) of the 1695 noncurative ER lesions with a possible risk of lymph node (LN) metastasis. Among them, 64 (7.8%) exhibited LN metastasis. Conclusions: This multicenter prospective study showed favorable short-term outcomes for gastric ESD.

AB - Objectives: A Japanese multicenter prospective cohort study examining endoscopic resection (ER) for early gastric cancer (EGC) has been conducted using a Web registry developed to determine the short-term and long-term outcomes based on absolute and expanded indications. We hereby present the short-term outcomes of this study. Methods: All consecutive patients with EGC or suspected EGC undergoing ER at 41 participating institutions between July 2010 and June 2012 were enrolled and prospectively registered into the Web registry. The baseline characteristics were entered before ER, and the short-term outcomes were collected at 6 months following ER. Results: Nine thousand six hundred and sixteen patients with 10 821 lesions underwent ER (endoscopic submucosal dissection [ESD]: 99.4%). The median procedure time was 76 min, and R0 resections were achieved for 91.6% of the lesions. Postoperative bleeding and intraoperative perforation occurred in 4.4% and 2.3% of the patients, respectively. Significant independent factors correlated with a longer procedure time (120 min or longer) were as follows: tumor size >20 mm, upper-third location, middle-third location, local recurrent lesion, ulcer findings, gastric tube, male gender, and submucosa. Histopathologically, 10 031 lesions were identified as common-type gastric cancers. The median tumor size was 15 mm. Noncurative resections were diagnosed for 18.3% of the lesions. Additional surgery was performed for 48.6% (824 lesions) of the 1695 noncurative ER lesions with a possible risk of lymph node (LN) metastasis. Among them, 64 (7.8%) exhibited LN metastasis. Conclusions: This multicenter prospective study showed favorable short-term outcomes for gastric ESD.

KW - early gastric cancer

KW - endoscopic resection

KW - multicenter prospective study

KW - real-world evidence

KW - short-term outcome

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U2 - 10.1111/den.13246

DO - 10.1111/den.13246

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