A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG

Not Applicable

• Conditions: Siewert Type II Adenocarcinoma of Esophagogastric Junction; Esophagogastric Junction Adenocarcinoma

• Registration Number: NCT04423354
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary

Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of esophagogastric junction.

Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the eligibility criteria will be included in the study and undergo the transthoracic single-hole assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.

Primary study endpoints: The incidences of early postoperative complications and mortality.

The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year disease-free survival and overall survival.

Detailed Description

1. Surgery and oncology indicators,such as length of operation, intraoperative blood loss, transit thoracotomy or laparotomy rate, length of proximal tumor from esophageal resection margin, number of mediastinal lymph node dissections and the positive, number of abdominal lymph node dissections and the positive, tumor type and pathological stage, etc.;

2. Early postoperative recovery information ,such as time of first exhaust and defecation, time of leaving the bed, time of recovery of full and half-flow diet, time of removal of chest drainage tube, time of postoperative hospitalization, etc.

Study Timeline

• Study Start: 2019-03-25
• Study First Submitted: 2020-03-26
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-07
• Last Update Submitted: 2020-06-07
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2024-02-01
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Informed consent of patients;
• The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).
• The endoscopic biopsy was diagnosed with adenocarcinoma;
• Preoperative clinical staging was cT1-4aNanyM0
• No distant metastasis and invasion of surrounding organs were found;
• ECOG score ranged from 0 to 1;
• ASA score ranged from I to III.

Exclusion Criteria

• Pregnant or lactating women
• Have a severe mental illness
• History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer)
• History of other malignant tumors within 5 years
• History of unstable angina pectoris or myocardial infarction within 6 months
• FEV1% of pulmonary function test was less than 50% of expected value
• History of cerebral infarction or cerebral hemorrhage within 6 months
• Have severe liver and kidney damage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Perioperative mortality	Within 30 days after surgery	The incidence of death due to the surgery
The incidences of early perioperative complications	Within 30 days after surgery	The early perioperative complications include anastomotic fistula, anastomotic stenosis, gastrointestinal dysfunction, chest or abdominal infection, chest or abdominal hemorrhage, respiratory complications, cardiovascular and cerebrovascular accidents, embolism and so on.

Secondary Outcome Measures

Name	Time	Method
The rate of transit thoracotomy or laparotomy	From the beginning of anesthesia to the completion of surgery	Thoracic or abdominal incisions greater than 10cm are considered to be converted to open chest or abdomen.
Intraoperative mortality	From the beginning of anesthesia to the completion of surgery	The rate of death during the surgery.
The tumor type	About 7 days.	Such as squamous cell carcinoma, adenocarcinoma, etc.
The duration of postoperative hospitalization	Time from end of surgery to discharge,about 7 days.	The duration from the end of the operation to hospital discharge.
5-year disease-free survival rate	5 years after surgery	Disease-free survival rate during 5 years after surgery
Duration of operation	From the beginning of anesthesia to the completion of surgery	The time it takes to complete the operation
Intraoperative blood loss	From the beginning of anesthesia to the completion of surgery	Total blood lost during surgery
Proximal marginal distance	From the beginning of anesthesia to the completion of surgery	The length of proximal tumor from esophageal resection margin.
The number of abdominal lymph node dissections and the positive	About 7 days.	The abdominal lymph nodes include NO.1,NO.2,NO.3,NO.4,NO.5,NO.6,NO.7,NO.8,NO.9,NO.10,NO.11,NO.12,NO.13,NO.14.
The pathological stage	About 7 days.	Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer
The duration of first exhaust	Time from end of surgery to discharge,about 7 days.	The duration from the end of the operation to the first exhaust after the operation.
The duration of restoration of full flow diet	Time from end of surgery to discharge,about 7 days.	The duration from the end of the operation to restore to a full-flow diet after the operation.
The duration of restoration of half-flow diet	Time from end of surgery to discharge,about 7 days.	The duration from the end of the operation to restore to a half-flow diet after the operation.
The duration of first defecation	Time from end of surgery to discharge,about 7 days.	The duration from the end of the operation to the first defecation after the operation.
The number of mediastinal lymph node dissections and the positive	About 7 days.	The mediastinal lymph nodes include NO.19,NO.20,NO.105,NO.106,NO.107,NO.108,NO.109,N0.110,NO.111,NO.112.
The duration of first leaving the bed	Time from end of surgery to discharge,about 7 days.	The duration from the end of the operation to the first leaving the bed after the operation.
The duration of removal of chest drainage tube	Time from end of surgery to discharge,about 7 days.	The duration from the end of the operation to remove the chest drainage tube after the operation.
3-year disease-free survival rate	3 years after surgery	Disease-free survival rate during 3 years after surgery
3-year overall survival rate	3 years after surgery	Overall survival rate during 3 years after surgery
5-year overall survival rate	5 years after surgery	Overall survival rate during 5 years after surgery

Trial Locations

Locations (1)

Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China