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NCT Number: NCT05938309

A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastric Surgery, Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location status: Recruiting

Location contact

Changming Huang, MD

CONTACT

[email protected]

+8613805069676

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years < age < 75 years
  • Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or MR, and confirmed as primary gastric GIST by postoperative pathology
  • Patient informed consent and willingness to undergo laparoscopic resection
  • Expected laparoscopic outcome of R0 resection
  • Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists(ASA) score I-III

Exclusion criteria

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)
  • History of gastric surgery (except ESD/EMR for gastric cancer)
  • History of other malignant diseases within the past five years
  • History of unstable angina or myocardial infarction within the past six months
  • History of a cerebrovascular accident within the past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other diseases
  • Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer

Treatment and study plan

Primary outcomes

  1. Overall postoperative morbidity

    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.

Secondary outcomes

  1. intraoperative morbidity rates

    Time frame: 1 day

    The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

  2. Conversion to open surgery rate

    Time frame: 1 day

    Conversion to open surgery rate is defined as the rate of open surgery whatever the reason

  3. Positive surgical margin rate

    Time frame: 1 day

    Positive surgical margin rate

  4. The variation of white blood cell count

    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.

  5. The variation of hemoglobin

    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.

  6. The variation of C-reactive protein

    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

  7. overall postoperative serious morbidity rates

    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.

  8. Time to first ambulation

    Time frame: 30 days

    Time to first ambulation in days is used to assess the postoperative recovery course.

  9. Time to first flatus

    Time frame: 30 days

    Time to first flatus in days is used to assess the postoperative recovery course.

  10. Time to first liquid diet

    Time frame: 30 days

    Time to first liquid diet in days is used to assess the postoperative recovery course.

  11. Time to first soft diet

    Time frame: 30 days

    Time to first soft diet in days is used to assess the postoperative recovery course.

  12. Duration of postoperative hospital stay

    Time frame: 30 days

    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

  13. 3-year overall survival rate

    Time frame: 36 months

    3-year overall survival rate

  14. 3-year disease free survival rate

    Time frame: 36 months

    3-year disease free survival rate

  15. 3-year recurrence pattern

    Time frame: 36 months

    Recurrence patterns are classified into four categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, and mixed type

Study contacts

Contact information is provided by the study sponsor or research team.

Linghua Wei

CONTACT

[email protected]

+8613512556021

Ping Li, MD,PhD

CONTACT

[email protected]

+8613365918502

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Collaborators

  • 900th Hospital of PLA Joint Logistic Support Force
  • First Affiliated Hospital of Fujian Medical University
  • Fujian Cancer Hospital
  • Fujian Provincial Hospital
  • Longyan City First Hospital
  • The Affiliated Hospital(Group) of Putian University
  • The First Affiliated Hospital of Xiamen University
  • The First Hospital of Putian City
  • The Second Affiliated Hospital of Fujian Medical University
  • Zhangzhou Municipal Hospital of Fujian Province

Registry information

Official study title

A Prospective, Multicenter Cohort Study on the Efficacy and Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Jul 10, 2023
Registry last updated
Jul 10, 2023

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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