Clinical trial NCT02792881: The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer
Official title: The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer: A Prospective Trial (FUGES-004)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Remnant Gastric Cancer
Keywords: Laparoscopic Completion Total Gastrectomy
Remnant gastric cancer
Feasibility
Prognosis
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Morbidity
timeFrame: 30 days
Secondary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Mortality
timeFrame: 30days
measure: Rates of combined organ resection
timeFrame: 1 day
measure: Intraoperative morbidity rates
timeFrame: 1 day
measure: Number of retrieved lymph nodes
timeFrame: 1 day
measure: Operation time
timeFrame: 1 day
measure: Postoperative recovery course
timeFrame: 10 days
measure: Intraoperative blood loss
timeFrame: 1 day
measure: Inflammatory and immune response and nutrional status
timeFrame: 7 days
measure: Textbook Outcome
timeFrame: 30 days
measure: Technical performance
timeFrame: 1 day
measure: The Surgery Task Load Index (SURG-TLX)
timeFrame: 1 day
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Changming Huang, M.D.,Ph.D.
role: STUDY_CHAIR
References: