Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327481
• Other study ID #: FUGES-001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Stomach Neoplasms

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