The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer

Fujian Medical University

Status

Invitation-only

Conditions

Remnant Gastric Cancer

Treatments

Procedure: Laparoscopic completion total gastrectomy with D2 lymphadenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02792881

FUGES-004

Details and patient eligibility

About

This study aims to investigate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.

Full description

In 2005, since Yamada reported the first case of laparoscopic completion total gastrectomy (LCTG) for RGC, laparoscopic technology was widely used in the treatment of RGC. However, due to the low incidence and rapid aggravation of RGC, adhesion, anatomic changes, and more complex lymphatic pathways caused by the previous operation, the popularity of LCTG is limited. Therefore, higher level evidence is warranted to further confirm the safety, feasibility, and oncological outcomes of LCTG in patients with RGC. This prospective single-arm study is designed to evaluate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 75 years; Carcinomas arise in the remnant stomach following gastrectomy, irrespective of the histology of the primary lesion (benign or malignant) or its risk of recurrence, the extent of resection, or the method of reconstruction; cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 7th Edition; Performance status of 0 or 1 on ECOG scale; ASA class I, II, or III; Written informed consent.

Exclusion criteria

Distant metastasis in the preoperative examinations; Previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection); Other malignant diseases (except gastric cancer) within the past 5 years; Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes; Women during breast-feeding or pregnancy; Severe mental disorder; Unstable myocardial infarction, angina, or cerebrovascular accident within the past 6 months; History of continuous systematic administration of corticosteroids within one month; FEV1<50% of predicted values; Requirement of simultaneous surgery for other disease; Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer.