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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patients who are assigned to undergo gastrectomy for gastric gastrointestinal stromal tumors are included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

194 Participants
are grouped into 2 trial groups
Group A: large group
Group B: small group

Trial outcomes

Primary outcomes

1

Overall postoperative morbidity

This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.

Time frame
30 days after surgery or the first discharge ( if over 30 days hospital stay)

Secondary outcomes

1

intraoperative morbidity rates

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

Time frame
1 day
2

Conversion to open surgery rate

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

Time frame
1 day
3

Positive surgical margin rate

Positive surgical margin rate

Time frame
1 day
4

The variation of white blood cell count

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Medical University

Lead sponsor

Fujian Provincial Hospital

Collaborator

Fujian Cancer Hospital

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

900th Hospital of PLA Joint Logistic Support Force

Collaborator

The First Affiliated Hospital of Xiamen University

Collaborator

The Second Affiliated Hospital of Fujian Medical University

Collaborator

The First Hospital of Putian City

Collaborator

The Affiliated Hospital(Group) of Putian University

Collaborator

Zhangzhou Municipal Hospital of Fujian Province

Collaborator

Longyan City First Hospital

Collaborator