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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2022-10-31

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.

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Detailed Description

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Standard Operating Procedure (SOP)

1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
2. 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.
3. 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.
4. 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.
5. 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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ultrasonic scalpel surgery group

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.

Group Type EXPERIMENTAL

Ultrasonic scalpel

Intervention Type DEVICE

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

Monopolar electrocautery surgery group

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.

Group Type EXPERIMENTAL

Monopolar electrocautery

Intervention Type DEVICE

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 .

Interventions

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Monopolar electrocautery

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 .

Intervention Type DEVICE

Ultrasonic scalpel

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of traditional open D2 distal gastrectomy;
2. Predictively resectable diseases, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT2N0M0-T4aN3M0, IB-IIIC, except T4b;
3. Age：≤75 years, or ≥18 years;
4. Without serious disease;
5. Patients without previous history of upper abdominal surgery;
6. WHO performance score \<2;
7. No limit to sexual and race;
8. informed consent required;

Exclusion Criteria

1. 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;
2. Patient undergo emergency surgery due to bleeding or perforation;
3. Patients with other gastric malignant diseases, such as lymphoma and stromal tumors, etc;
4. Patients suffering from malignant diseases before the study;
5. 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.
6. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
7. Severity mental diseases;
8. After signature the Clinical trial agreement, patients and their agent will quit the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jian-Kun Hu

Deputy director of Department of Gastrointestinal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian-Kun Hu, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

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Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, China

Site Status RECRUITING