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

A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction

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.

Study Overview

• Status: Recruiting
• Conditions: Siewert Type II Adenocarcinoma of Esophagogastric Junction; Esophagogastric Junction Adenocarcinoma
• Intervention / Treatment: Procedure: Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction

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 Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wei wang, M.D.,Ph.D; Phone Number: +86-13922255515; Email: ww1640@yeah.net
• Study Contact Backup: Name: yuling xue, M.M.; Phone Number: +86-15014167320; Email: xueyuling1994@yeah.net

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Contact: Wei Wang, M.D.,PH.D.; Phone Number: +86-13922255515; Email: wangwei16400@163.com
      • Contact: Wenjun Xiong, M.D.; Phone Number: +86-15920553177; Email: xiongwj1988@163.com
      • Principal Investigator: Jin Wan
      • Principal Investigator: Wen jun Xiong
      • Principal Investigator: Yan sheng Zheng
      • Principal Investigator: Li jie Luo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Research group; Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy.

Procedure: Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction; Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidences of early perioperative complications	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.	Within 30 days after surgery
Perioperative mortality	The incidence of death due to the surgery	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of operation	The time it takes to complete the operation	From the beginning of anesthesia to the completion of surgery
Intraoperative blood loss	Total blood lost during surgery	From the beginning of anesthesia to the completion of surgery
The rate of transit thoracotomy or laparotomy	Thoracic or abdominal incisions greater than 10cm are considered to be converted to open chest or abdomen.	From the beginning of anesthesia to the completion of surgery
Intraoperative mortality	The rate of death during the surgery.	From the beginning of anesthesia to the completion of surgery
Proximal marginal distance	The length of proximal tumor from esophageal resection margin.	From the beginning of anesthesia to the completion of surgery
The number of mediastinal lymph node dissections and the positive	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.	About 7 days.
The number of abdominal lymph node dissections and the positive	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.	About 7 days.
The tumor type	Such as squamous cell carcinoma, adenocarcinoma, etc.	About 7 days.
The pathological stage	Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer	About 7 days.
The duration of first exhaust	The duration from the end of the operation to the first exhaust after the operation.	Time from end of surgery to discharge,about 7 days.
The duration of first defecation	The duration from the end of the operation to the first defecation after the operation.	Time from end of surgery to discharge,about 7 days.
The duration of first leaving the bed	The duration from the end of the operation to the first leaving the bed after the operation.	Time from end of surgery to discharge,about 7 days.
The duration of restoration of full flow diet	The duration from the end of the operation to restore to a full-flow diet after the operation.	Time from end of surgery to discharge,about 7 days.
The duration of restoration of half-flow diet	The duration from the end of the operation to restore to a half-flow diet after the operation.	Time from end of surgery to discharge,about 7 days.
The duration of removal of chest drainage tube	The duration from the end of the operation to remove the chest drainage tube after the operation.	Time from end of surgery to discharge,about 7 days.
The duration of postoperative hospitalization	The duration from the end of the operation to hospital discharge.	Time from end of surgery to discharge,about 7 days.
3-year overall survival rate	Overall survival rate during 3 years after surgery	3 years after surgery
3-year disease-free survival rate	Disease-free survival rate during 3 years after surgery	3 years after surgery
5-year overall survival rate	Overall survival rate during 5 years after surgery	5 years after surgery
5-year disease-free survival rate	Disease-free survival rate during 5 years after surgery	5 years after surgery

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: wei wang, M.D.,Ph.D, Guangdong PHTCM

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: June 7, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Esophageal Neoplasms
• Other Study ID Numbers: WWang

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No