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

Not Applicable

• Conditions: gastric cancer

• Registration Number: JPRN-UMIN000021131
• Lead Sponsor: Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Open public recruiting
• Sex: All
• Target Recruitment: 128

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the superiority of pylorus-preserving gastrectomy over distal gastrectomy in postoperative dumping syndrome incidence.

Secondary Outcome Measures

Name	Time	Method
quality of life (PGSAS37?EORTC), operative time, intraoperative blood loss, morbidity, mortality, short-term mortality