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Completed

NCT Number: NCT02327481

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

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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Laparoscopic Surgery

Procedure

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

Procedure

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.

Primary outcomes

  1. Operating time

    Time frame: 1 day

    Operating time

Secondary outcomes

  1. Intraoperative situation

    Time frame: 1 day

    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

  2. Postoperative recovery course

    Time frame: 10 days

    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.

  3. Complication

    Time frame: 30 days;36 months

    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

  4. The postoperative pathology

    Time frame: 7 days

    The postoperative pathological type and pTNM stage.

  5. Inflammatory and immune response

    Time frame: 7 days

    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.

  6. Morbidity and mortality

    Time frame: 30 days;36 months

    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.

  7. Hospitalization expenses

    Time frame: 1 months

    The cost from admission to discharge

  8. 3-year disease free survival rate

    Time frame: 36 months

    Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

  9. 3-year overall survival rate

    Time frame: 36 months

    Overall survival was defined as the time from surgery to death from any cause

  10. 5-year disease free survival rate

    Time frame: 60 months

    Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

  11. 5-year overall survival rate

    Time frame: 60 months

    Overall survival was defined as the time from surgery to death from any cause

  12. Recurrence patterns

    Time frame: 60 months

    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2021
First posted
Dec 30, 2014
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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