Department of Gastric Surgery, Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Location status: Recruiting
NCT Number: NCT05938309
The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Fuzhou, Fujian, China
Location status: Recruiting
There is a lack of high-quality evidence on the efficacy and safety of laparoscopic resection of gastric GIST over 5cm. A multicenter, prospective cohort study was conducted to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors (GIST) compared to laparoscopic resection of GIST of less than 5cm. The primary evaluation parameter is overall postoperative morbidity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 days after surgery or the first discharge ( if over 30 days hospital stay)
This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.
Time frame: 1 day
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time frame: 1 day
Conversion to open surgery rate is defined as the rate of open surgery whatever the reason
Time frame: 1 day
Positive surgical margin rate
Time frame: Preoperative 7 days and postoperative 1, 3, and 5 days
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 7 days and postoperative 1, 3, and 5 days
The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 7 days and postoperative 1, 3, and 5 days
The values of C-reactive protein in milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response
Time frame: 30 days after surgery or the first discharge ( if over 30 days hospital stay)
According to the Clavien-Dindo complication scoring system, grade IIIA and above is a serious complication, and when multiple complications occur at the same time, the complication with the highest grade will prevail.
Time frame: 30 days
Time to first ambulation in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first flatus in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first soft diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 36 months
3-year overall survival rate
Time frame: 36 months
3-year disease free survival rate
Time frame: 36 months
Recurrence patterns are classified into four categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, and mixed type
Contact information is provided by the study sponsor or research team.
Linghua Wei
CONTACT
Ping Li, MD,PhD
CONTACT
Fujian Medical University
Other
A Prospective, Multicenter Cohort Study on the Efficacy and Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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