An interventional study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction in Esophagogastric Junction Adenocarcinoma and Siewert Type II Adenocarcinoma of Esophagogastric Junction, sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's planned enrollment of 94 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Guangdong Provincial Hospital of Traditional Chinese Medicine is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: Within 30 days after surgery
Perioperative mortality
The incidence of death due to the surgery
Time frame: Within 30 days after surgery
Duration of operation
The time it takes to complete the operation
Time frame: From the beginning of anesthesia to the completion of surgery
Intraoperative blood loss
Total blood lost during surgery
Time frame: 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.
Time frame: From the beginning of anesthesia to the completion of surgery
Intraoperative mortality
The rate of death during the surgery.
Time frame: From the beginning of anesthesia to the completion of surgery
Proximal marginal distance
The length of proximal tumor from esophageal resection margin.
Time frame: 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.
Time frame: 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.
Time frame: About 7 days.
The tumor type
Such as squamous cell carcinoma, adenocarcinoma, etc.
Time frame: About 7 days.
The pathological stage
Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer
Time frame: About 7 days.
The duration of first exhaust
The duration from the end of the operation to the first exhaust after the operation.
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Time from end of surgery to discharge,about 7 days.
3-year overall survival rate
Overall survival rate during 3 years after surgery
Time frame: 3 years after surgery
3-year disease-free survival rate
Disease-free survival rate during 3 years after surgery
Time frame: 3 years after surgery
5-year overall survival rate
Overall survival rate during 5 years after surgery
Time frame: 5 years after surgery
5-year disease-free survival rate
Disease-free survival rate during 5 years after surgery
Time frame: 5 years after surgery
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Guangdong Provincial Hospital of Traditional Chinese Medicine