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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02327481
Other study ID # FUGES-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2015
Est. completion date April 26, 2021

Study information

Verified date April 2023
Source Fujian Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.


Description:

A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-year survival and recurrence rates.


Recruitment information / eligibility

Status Completed
Enrollment 438
Est. completion date April 26, 2021
Est. primary completion date April 26, 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years to 74 Years
Eligibility Inclusion Criteria: - (1)Age from over 19 to under 74 years - (2)cT1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition - (3)Heart, lungs, kidneys, and other vital organs function well, with no obvious surgical contraindications - (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around the main abdominal artery, and tumor not a direct violation of the pancreas, spleen, and other surrounding organs - (5)American Society of Anesthesiology (ASA) score class I, II, or III - (6)Written informed consent Exclusion Criteria: - (1)Women during pregnancy or breast-feeding - (2)Severe mental disorder - (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy) - (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels - (5)History of unstable angina or myocardial infarction within the past six months - (6)History of cerebrovascular accident within the past six months - (7)History of continuous systematic administration of corticosteroids within one month - (8)History of previous neoadjuvant chemotherapy or radiotherapy - (9)T4b tumors - (10)Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer - (11)FEV1(Forced expiratory volume in one second)<50% of predicted values

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
3D Laparoscopic Surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 3D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
2D Laparoscopic Surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 2D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fujian Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary Operating time Operating time 1 day
Secondary Intraoperative situation The number of lymph node dissection, the number of positive lymph nodes, intraoperative lymph node dissection time(regional analysis: infrapyloric area lymph node, suprapancreatic area lymph node, splenic hilar area lymph node, cardial area lymph node), intracavitary anastomosis time(patients who undergo totally laparoscopic surgery are analyzed), intraoperative blood loss, intraoperative injury, the amount of use of titanium clip, the rate of conversion to laparotomy 1 day
Secondary Postoperative recovery course Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree. 10 days
Secondary Complication Early complications occurred within 30 days after operation: pulmonary infection, incision complication, intestinal obstruction, abdominal infection, anastomotic bleeding, anastomotic fistula, gastric emptying; Long-term complications (30 days later after operation): anastomotic stenosis, intestinal obstruction, dumping syndrome 30 days;36 months
Secondary The postoperative pathology The postoperative pathological type and pTNM stage. 7 days
Secondary Inflammatory and immune response The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. 7 days
Secondary Morbidity and mortality The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th. 30 days;36 months
Secondary Hospitalization expenses The cost from admission to discharge 1 months
Secondary 3-year disease free survival rate Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause 36 months
Secondary 3-year overall survival rate Overall survival was defined as the time from surgery to death from any cause 36 months
Secondary 5-year disease free survival rate Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause 60 months
Secondary 5-year overall survival rate Overall survival was defined as the time from surgery to death from any cause 60 months
Secondary Recurrence patterns Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. 60 months
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