Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery

Study Overview
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Brief Summary
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Gastric cancer as one of the most common gastrointestinal cancers, radical resection of primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. By the invented and adopted energy surgical instruments, surgical procedure is safer and easier than before. The newly surgical instruments reduce the post-operative mortality and morbidity combined easy procedures of surgery. As the most popular instruments used in the gastric surgery, ultrasonic scalpel and monopolar electrocautery were received lots of attention and concern. Some studies have shown some advantage of the two instruments, which were they can facilitate the surgical treatment and make the surgery safer and more effective. Although, some small retrospective sample reports claimed that ultrasonic scalpel brought benefit in blood loss, dissection lymph-node intraoperative complications and even postoperative complications. And Korea small sample randomized controlled trail presentation that ultrasonic scalpel can reduced blood loss and surgical duration. However, postoperative complications were with no statistical significance between the two instruments. Cost- effective analysis of the energy instruments is still controversial. Large sample randomized control trail with high quality is needed. By the reasons above, a multicenter randomized controlled trial conducted by 9 hospitals from North to South in China aims to compare the clinical characteristics and outcomes, when using of the ultrasonic scalpel or monopolar electrocautery in traditional open gastrectomy. The aim of this study is to evaluate the outcomes of ultrasonic scalpel compared with monopolar electrocautery in D2 distal gastrectomy, include, intraoperative parameters, postoperative complications, cost data, and post-operative quality of life.

Detailed Description
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Standard Operating Procedure (SOP) Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent. Randomization preoperative evaluation found that R0, D2 Gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications. Surgical procedures The surgical treatments is adopted the traditional open gastrectomy approach and adjuvant D2 lymphadenectomy. The SOP of the surgical treatments are according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Postoperative recovery Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study. Follow-up The follow-up of this study divide into two parts, the postoperative quality of life and tumor characteristics outcomes. The information of the postoperative quality of life is collected by the EuroQol-5 Dimensions (EQ-5D) questionnaire in four postoperative time intervals. The tumor related outcomes included long-term postoperative complications, recurrence type, relapse free survival (months) and the overall survival (months).

Official Title
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Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery: a Multicenter Randomized Controlled Trial

Conditions
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Surgery, Ultrasonic Scalpel, Monopolar Electrocautery, Operation Time, Gastric Cancer, Blood Loss, Surgical, Quality of Life, External Causes of Morbidity and Mortality

Intervention / Treatment
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* Device: Monopolar electrocautery
* Device: Ultrasonic scalpel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of traditional open D2 distal gastrectomy; Predictively resectable diseases, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT2N0M0-T4aN3M0, IB-IIIC, except T4b; Age：≤75 years, or ≥18 years; Without serious disease; Patients without previous history of upper abdominal surgery; WHO performance score <2; No limit to sexual and race; informed consent required; Exclusion Criteria: primary lesion cannot be resected in the pattern of transabdominal distal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection (include the cholecystectomy) or with a transthoracic approach surgery; Patient undergo emergency surgery due to bleeding or perforation; Patients with other gastric malignant diseases, such as lymphoma and stromal tumors, etc; Patients suffering from malignant diseases before the study; Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe Chronic Obstruction Pulmonary Disease (COPD), chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation; Severity mental diseases; After signature the Clinical trial agreement, patients and their agent will quit the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonic scalpel surgery group<br>During the procedures of the abdominal approach D2 distal gastrectomy, use ultrasonic scalpel (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes; some great vessels can ligation by nylon, silk line or Hemolock. | Device: Ultrasonic scalpel<br>* During the procedures of the abdominal approach D2 distal gastrectomy, use ultrasonic scalpel (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes<br>|
| Experimental: Monopolar electrocautery surgery group<br>During the procedures of the abdominal approach D2 distal gastrectomy, use monopolar electrocautery (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes; some great vessels can ligation by nylon, silk line or Hemolock. | Device: Monopolar electrocautery<br>* During the procedures of the abdominal approach D2 distal gastrectomy, use the monopolar electrocautery (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical duration | From the skin incision to finish the suture of abdominal wall | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | The intraoperative blood loss | Intraoperative | 
| Number of harvested and positive lymph nodes | Number of harvested and positive lymph nodes by pathological results | Postoperative | 
| Intraoperative Mortality and Morbidity | Evaluation the intraoperative mortality and morbidity | Intraoperative | 
| Survival outcome | the survival outcomes include the 3-year overall survival rate and 3-year disease free survival rate | 3 years | 
| Postoperative Mortality and Morbidity | Evaluation the postoperative (30 days) mortality and morbidity | Postoperative (30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbidity, Stomach Neoplasms, Operative Time, Gastrectomy, Surgical Hemorrhage, Mortality