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

Esophagogastric Junction Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423354
• Other study ID #: WWang
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2020
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: wei wang, M.D.,Ph.D
• Phone: +86-13922255515
• Email: ww1640[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: March 31, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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(Siewert?).

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophagogastric Junction Adenocarcinoma
• Siewert Type II Adenocarcinoma of Esophagogastric Junction

Intervention

Procedure:
• Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type ? Adenocarcinoma of Esophagogastric Junction
Patients diagnosed with Siewert ? 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.

Locations

Country	Name	City	State
China	Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Perioperative mortality	The incidence of death due to the surgery	Within 30 days after surgery
Secondary	Duration of operation	The time it takes to complete the operation	From the beginning of anesthesia to the completion of surgery
Secondary	Intraoperative blood loss	Total blood lost during surgery	From the beginning of anesthesia to the completion of surgery
Secondary	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
Secondary	Intraoperative mortality	The rate of death during the surgery.	From the beginning of anesthesia to the completion of surgery
Secondary	Proximal marginal distance	The length of proximal tumor from esophageal resection margin.	From the beginning of anesthesia to the completion of surgery
Secondary	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.
Secondary	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.
Secondary	The tumor type	Such as squamous cell carcinoma, adenocarcinoma, etc.	About 7 days.
Secondary	The pathological stage	Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer	About 7 days.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	3-year overall survival rate	Overall survival rate during 3 years after surgery	3 years after surgery
Secondary	3-year disease-free survival rate	Disease-free survival rate during 3 years after surgery	3 years after surgery
Secondary	5-year overall survival rate	Overall survival rate during 5 years after surgery	5 years after surgery
Secondary	5-year disease-free survival rate	Disease-free survival rate during 5 years after surgery	5 years after surgery