Evaluation of postoperative quality of life after Billroth-I distal gastrectomy and pylorus-preserving gastrectomy for Stage I gastric cancer

UMIN ID: UMIN000021131

Registered date:01/03/2016

Basic Information

• Recruitment status: Open public recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 2016/02/01
• Target sample size: 128
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: To demonstrate the superiority of pylorus-preserving gastrectomy over distal gastrectomy in postoperative dumping syndrome incidence.
• Secondary Outcome: quality of life (PGSAS37･EORTC), operative time, intraoperative blood loss, morbidity, mortality, short-term mortality

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female

Include criteria

1) pathologically-confirmed gastric cancer (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, signet ring cell carcinoma and mucinous adenocarcinoma)
2) cStage IA or IB, but not T2 tumor at the greater curvature of the stomach
3) No indication of endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) in a cN0 or cN1case
4) Patients who underwent EMR or ESD and need additional surgery
5) Aged 20 to 80 year
6) PS (ECOG) 0 or 1
7) No history of gastrointestinal surgery
8) No history of chemotherapy or radiotherapy
9) Capability of filling out a survey independently
10) Provided written informed consent

Exclude criteria

1) Synchronous or metachronous malignancies other than carcinoma in situ
2) Simultaneous surgery other than cholecystectomy
3) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator

Related Information

• Primary Sponsor: Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
• Source(s) of Monetary Support: None