Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.

Detailed Description
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A prospective randomized comparison of HD and 4K 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 4K laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Official Title
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Randomized Controlled Trials Comparing Clinical Outcome of HD Versus 4K Laparoscopy for Gastric Cancer(FUGES-017)

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Procedure: 4K Laparoscopic Surgery
* Procedure: HD Laparoscopic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1)Age from over 19 to under 74 years (2)cT 1-4a(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 abdominal main 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 past six months (6)History of cerebrovascular accident within 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4K Laparoscopic Surgery<br>4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. | Procedure: 4K Laparoscopic Surgery<br>* 4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.<br>|
| Active Comparator: HD Laparoscopic Surgery<br>HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. | Procedure: HD Laparoscopic Surgery<br>* HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operating time | day | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of lymph node dissection | number | 1 day | 
| the number of positive lymph nodes | the number of positive lymph nodes | 1 day | 
| intraoperative lymph node dissection time | (regional analysis:infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node,cardial area lymph node) | 1 day | 
| intracavitary anastomosis time | (patients who undergo totally laparoscopic surgery are analyzed) | 1 day | 
| intraoperative blood loss | ml | 1 day | 
| intraoperative injury | intraoperative injury | 1 day | 
| the amount of use of titanium clip | the amount of use of titanium clip | 1 day | 
| the rate of conversion to laparotomy | the rate of conversion to laparotomy | 1 day | 
| Time to first ambulation | Time to first ambulation | 10 days | 
| Time to first flatus | Time to first flatus | 10 days | 
| Time to first liquid diet | Time to first liquid diet | 10 days | 
| Time to first soft diet | Time to first soft diet | 10 days | 
| duration of postoperative hospital stay | duration of postoperative hospital stay | 10 days | 
| 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 | 
| The daily highest body temperature before discharge | The daily highest body temperature before discharge | 7 days | 
| Overall postoperative morbidity and mortality rates | The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative and postoperative morbidity and mortality as the numerator are used to calculate the proportions. Postoperative morbidities are divided into short-term and long-term complications after surgery. Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is > 30 days. Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery >30 days) and 3 years after the operation. Postoperative mortality: patients whose death was identified according to documented intraoperative observation items, including patients who die within 30 days after surgery (including the 30th day) regardless of the causality between death and surgery, and patients who die more than 30 days after surgery. | 30 days | 
| Hospitalization expenses | dolloars | 1 months | 
| 3-year disease free survival rate | month | 36 months | 
| 3-year overall survival rate | month | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach Neoplasms, Laparoscopy