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

NCT04423354 | Unknown

• 1 other identifier: WWang
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagogastric Junction Adenocarcinoma; Siewert Type II Adenocarcinoma of Esophagogastric Junction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Duration of operation

  From the beginning of anesthesia to the completion of surgery

• Intraoperative blood loss

  From the beginning of anesthesia to the completion of surgery

• The rate of transit thoracotomy or laparotomy

  From the beginning of anesthesia to the completion of surgery

• Intraoperative mortality

  From the beginning of anesthesia to the completion of surgery

• Proximal marginal distance

  From the beginning of anesthesia to the completion of surgery

Study Arms (1)

Research group

EXPERIMENTAL

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

Interventions

Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction PROCEDURE

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.

Research group

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Study Officials

• wei wang, M.D.,Ph.D

  Guangdong PHTCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei wang, M.D.,Ph.D

CONTACT

+86-13922255515; ww1640@yeah.net

yuling xue, M.M.

CONTACT

+86-15014167320; xueyuling1994@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: June 9, 2020
• Study Start: March 25, 2019
• Primary Completion: February 1, 2024
• Study Completion: March 31, 2024
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

CN (1)