NCT04423354|Unknown
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Sponsor study identifier
interventional
94
1 country
1
Study Start
March 25, 2019
Actual (reported)Primary Completion
February 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 25, 2019
Actual (reported)March 26, 2020
Actual (reported)June 9, 2020
Actual (reported)February 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510120, China
wei wang, M.D.,Ph.D
Guangdong PHTCM
First Submitted
March 26, 2020
First Posted
June 9, 2020
Study Start
March 25, 2019
Actual (reported)Primary Completion
February 1, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 9, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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