GIST of StomachNCT03716089
Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site
An observational study of GIST of Stomach and Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GIST of Stomach, Gastric Cancer, Surgery
- What is being tested?
- Laparoscopic resection
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2018to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the inclusion criteria and not conform to the exclusion criteria are qualified for this study.
Who may be able to join
- Age between 18 and 75 years old
- Primary gastric lesion confirmed pathologically GIST by endoscopic biopsy. Preoperative endoscopy, ultrasound endoscopy or computer tomography, Magnetic resonance suspected GIST, and then postoperative pathology confirmed as the original GIST
- Written informed consent
- Expected R0 resection by laparoscopy
- Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Maximum tumor diameter ≤10cm
Who cannot join
- Pregnant and lactating women
- Suffering from a severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- Rejection of laparoscopic resection
- History of other malignant disease within the past five years
Show all 13Show fewer
- 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 another disease
- Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
- Maximum tumor diameter >10cm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Changming Huang, Professor, +8613805069676, hcmlr2002@163.com
About this study
Official title: Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site（FUGES-016）
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.
Read the detailed description
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy. Main end of study: 3-year disease free survival rate
- Conditions
- GIST of Stomach, Gastric Cancer, Surgery, Complication
- Being tested
- Laparoscopic resection
- Keywords
- GIST, laparoscopic resection, early complication, mortality, tumor sites
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic resectionProcedure or surgery
Laparoscopic surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group A (Study group) | Group for laparoscopic resection of GIST with unfavorable group (Unfavorable group) Receives: Procedure: Laparoscopic resection | |
| Group B (Control group) | Group for laparoscopic resection of GIST with favorable group (favorable group) Receives: Procedure: Laparoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
Definition of recurrence and recurrence date The following situations are regarded as "recurrence"
- Recurrence identified by any one image examination (X-ray, ultrasound, computed tomography, magnetic resonance imaging, etc.) and, if there are a variety of imaging examinations, results without contradiction determined "recurrence". The earliest date that the recurrence is found is defined as the "recurrence date".
- For cases that lack the use of imaging or a pathological diagnosis, the date of diagnosing the occurrence of clinical recurrence based on clinical history and physical examination is defined as the "recurrence date".
- For cases without imaging or clinical diagnosis but with a cytology or tissue biopsy pathological diagnosis of recurrence, the earliest date confirmed by cytology or biopsy pathology is considered the "recurrence date".
- A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse.
Measured: 36 months
Secondary outcomes (17)
Intraoperative morbidity rates
- . The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative morbidity as the numerator are used to calculate the proportions.
- . Intraoperative morbidity (occurring from skin incision to skin closure) including: surgery-related morbidity: intraoperative hemorrhage and injury:
Measured: 30 days
Conversion to open surgery rate
- . In this study, if the length of the auxiliary incision is more than 10 cm, it is considered a conversion to open surgery.
- .The number of all patients treated with surgery as the denominator and the number of the patients with conversion to open surgery as the numerator are used to calculate the proportions.
Measured: 30 days
Positive surgical margin rate
- . The investigators confirm the surgical margin status by postoperative pathology report.
- . The number of all patients treated with surgery as the denominator and the number of the patients with positive surgical margin as the numerator are used to calculate the proportions.
Measured: 30 days
Overall postoperative serious complications rates
- . Incidence of postoperative major complications: The standard for postoperative major complications refers to the short-term complications according to the Clavien-dindo grade, IIIA level and above for serious complications, and when multiple complications occur simultaneously, the highest ranked complication is the subject.
- . Postoperative complications are divided into short-term complications after surgery and long-term complications after surgery. (3)Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is > 30 days. (4)Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery >30 days) and 3 years after the operation.
Measured: 30 days
3-year overall survival rate
- The overall survival is calculated from the day of surgery until death or until the final follow-up date, whichever occurs first.
- For survival cases, the end point is the last date that survival was confirmed. If loss to follow-up occurred, the end point is the final date that survival could be confirmed.
Measured: 36 months
3-year recurrence pattern
Definition of recurrence and recurrence date The following situations are regarded as "recurrence"
- Recurrence identified by any one image examination (X-ray, ultrasound, computed tomography, magnetic resonance imaging, etc.) and, if there are a variety of imaging examinations, results without contradiction determined "recurrence". The earliest date that the recurrence is found is defined as the "recurrence date".
- For cases that lack the use of imaging or a pathological diagnosis, the date of diagnosing the occurrence of clinical recurrence based on clinical history and physical examination is defined as the "recurrence date".
- For cases without imaging or clinical diagnosis but with a cytology or tissue biopsy pathological diagnosis of recurrence, the earliest date confirmed by cytology or biopsy pathology is considered the "recurrence date".
- A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse.
Measured: 36 months
Overall postoperative morbidity and mortality rates
- The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative and postoperative morbidity and mortality as the numerator are used to calculate the proportions.
- Postoperative morbidities are divided into short-term and long-term complications after surgery.
- Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is > 30 days.
- Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery >30 days) and 3 years after the operation.
- Postoperative mortality: patients whose death was identified according to documented intraoperative observation items, including patients who die within 30 days after surgery (including the 30th day) regardless of the causality between death and surgery, and patients who die more than 30 days after surgery.
Measured: 30 days
Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Measured: 30 days
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Measured: 30 days
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Measured: 30 days
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Measured: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Measured: 30 days
Intraoperative tumor rupture rates
Intraoperative tumor rupture rates are used to access the oncological safety of the intervention.
Measured: 1 day
The variation of album
The variation of album in gram/liter on preoperative 7 days and postoperative 1 and 5 days are used to access the postoperative nutritional status and quality of life.
Measured: Preoperative 7 days and postoperative 1 and 5 days
The variation of hemoglobin
The variation of hemoglobin in gram/liter on preoperative 7 days and postoperative 1 and 5 days are used to access the postoperative nutritional status and quality of life.
Measured: Preoperative 7 days and postoperative 1 and 5 days
The variation of white blood cell count
The values of white blood cell count from peripheral blood preoperative 7 days and postoperative 1 and 5 days are recorded to access the inflammatory and immune response.
Measured: Preoperative 7 days and postoperative 1 and 5 days
The variation of C-reactive protein
The values of C-reactive protein IN milligram/liter from peripheral blood preoperative 7 days and postoperative 1 and 5 days are recorded to access the inflammatory and immune response.
Measured: Preoperative 7 days and postoperative 1 and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start11 Oct 2018
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for GIST of StomachStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716089
- Sponsor's protocol ID
- FUGES-016
- Status last verified
- Apr 2025
- First submitted
- 14 Oct 2018
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pidhorecky I, Cheney RT, Kraybill WG, Gibbs JF. Gastrointestinal stromal tumors: current diagnosis, biologic behavior, and management. Ann Surg Oncol. 2000 Oct;7(9):705-12. doi: 10.1007/s10434-000-0705-6.
PubMed 11034250Demetri GD, von Mehren M, Antonescu CR, DeMatteo RP, Ganjoo KN, Maki RG, Pisters PW, Raut CP, Riedel RF, Schuetze S, Sundar HM, Trent JC, Wayne JD. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010 Apr;8 Suppl 2(0 2):S1-41; quiz S42-4. doi: 10.6004/jnccn.2010.0116.
PubMed 20457867Miettinen M, Majidi M, Lasota J. Pathology and diagnostic criteria of gastrointestinal stromal tumors (GISTs): a review. Eur J Cancer. 2002 Sep;38 Suppl 5:S39-51. doi: 10.1016/s0959-8049(02)80602-5.
PubMed 12528772Karakousis GC, Singer S, Zheng J, Gonen M, Coit D, DeMatteo RP, Strong VE. Laparoscopic versus open gastric resections for primary gastrointestinal stromal tumors (GISTs): a size-matched comparison. Ann Surg Oncol. 2011 Jun;18(6):1599-605. doi: 10.1245/s10434-010-1517-y. Epub 2011 Jan 5.
PubMed 21207158Melstrom LG, Phillips JD, Bentrem DJ, Wayne JD. Laparoscopic versus open resection of gastric gastrointestinal stromal tumors. Am J Clin Oncol. 2012 Oct;35(5):451-4. doi: 10.1097/COC.0b013e31821954a7.
PubMed 21552096Koh YX, Chok AY, Zheng HL, Tan CS, Chow PK, Wong WK, Goh BK. A systematic review and meta-analysis comparing laparoscopic versus open gastric resections for gastrointestinal stromal tumors of the stomach. Ann Surg Oncol. 2013 Oct;20(11):3549-60. doi: 10.1245/s10434-013-3051-1. Epub 2013 Jun 21.
PubMed 23793362Ganai S, Prachand VN, Posner MC, Alverdy JC, Choi E, Hussain M, Waxman I, Patti MG, Roggin KK. Predictors of unsuccessful laparoscopic resection of gastric submucosal neoplasms. J Gastrointest Surg. 2013 Feb;17(2):244-55; discussion 255-6. doi: 10.1007/s11605-012-2095-z. Epub 2012 Dec 8.
PubMed 23225195De Vogelaere K, Hoorens A, Haentjens P, Delvaux G. Laparoscopic versus open resection of gastrointestinal stromal tumors of the stomach. Surg Endosc. 2013 May;27(5):1546-54. doi: 10.1007/s00464-012-2622-8. Epub 2012 Dec 12.
PubMed 23233005Bischof DA, Kim Y, Dodson R, Carolina Jimenez M, Behman R, Cocieru A, Blazer DG 3rd, Fisher SB, Squires MH 3rd, Kooby DA, Maithel SK, Groeschl RT, Clark Gamblin T, Bauer TW, Karanicolas PJ, Law C, Quereshy FA, Pawlik TM. Open versus minimally invasive resection of gastric GIST: a multi-institutional analysis of short- and long-term outcomes. Ann Surg Oncol. 2014 Sep;21(9):2941-8. doi: 10.1245/s10434-014-3733-3. Epub 2014 Apr 24.
PubMed 24763984Lin J, Huang C, Zheng C, Li P, Xie J, Wang J, Lu J. Laparoscopic versus open gastric resection for larger than 5 cm primary gastric gastrointestinal stromal tumors (GIST): a size-matched comparison. Surg Endosc. 2014 Sep;28(9):2577-83. doi: 10.1007/s00464-014-3506-x. Epub 2014 May 23.
PubMed 24853837Honda M, Hiki N, Nunobe S, Ohashi M, Kiyokawa T, Sano T, Yamaguchi T. Long-term and surgical outcomes of laparoscopic surgery for gastric gastrointestinal stromal tumors. Surg Endosc. 2014 Aug;28(8):2317-22. doi: 10.1007/s00464-014-3459-0. Epub 2014 Feb 25.
PubMed 24566748Masoni L, Gentili I, Maglio R, Meucci M, D'Ambra G, Di Giulio E, Di Nardo G, Corleto VD. Laparoscopic resection of large gastric GISTs: feasibility and long-term results. Surg Endosc. 2014 Oct;28(10):2905-10. doi: 10.1007/s00464-014-3552-4. Epub 2014 May 31.
PubMed 24879133Hsiao CY, Yang CY, Lai IR, Chen CN, Lin MT. Laparoscopic resection for large gastric gastrointestinal stromal tumor (GIST): intermediate follow-up results. Surg Endosc. 2015 Apr;29(4):868-73. doi: 10.1007/s00464-014-3742-0. Epub 2014 Jul 23.
PubMed 25052129Chen K, Zhou YC, Mou YP, Xu XW, Jin WW, Ajoodhea H. Systematic review and meta-analysis of safety and efficacy of laparoscopic resection for gastrointestinal stromal tumors of the stomach. Surg Endosc. 2015 Feb;29(2):355-67. doi: 10.1007/s00464-014-3676-6. Epub 2014 Jul 9.
PubMed 25005014Dressler JA, Palazzo F, Berger AC, Stake S, Chaudhary A, Chojnacki KA, Rosato EL, Pucci MJ. Long-term functional outcomes of laparoscopic resection for gastric gastrointestinal stromal tumors. Surg Endosc. 2016 Apr;30(4):1592-8. doi: 10.1007/s00464-015-4384-6. Epub 2015 Jul 14.
PubMed 26169640
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site（FUGES-016）
- ClinicalTrials.gov ID
- NCT03716089
- Acronym / sponsor ID
- FUGES-016
- Conditions
- GIST of Stomach, Gastric Cancer, Surgery, Complication
- Keywords
- GIST, laparoscopic resection, early complication, mortality, tumor sites
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.
Detailed description
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy. Main end of study: 3-year disease free survival rate
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Study group) | – | Procedure: Laparoscopic resectionGroup for laparoscopic resection of GIST with unfavorable group (Unfavorable group) |
| Group B (Control group) | – | Procedure: Laparoscopic resectionGroup for laparoscopic resection of GIST with favorable group (favorable group) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the inclusion criteria and not conform to the exclusion criteria are qualified for this study.
Key inclusion criteria (7 listed)
- Age between 18 and 75 years old
- Primary gastric lesion confirmed pathologically GIST by endoscopic biopsy. Preoperative endoscopy, ultrasound endoscopy or computer tomography, Magnetic resonance suspected GIST, and then postoperative pathology confirmed as the original GIST
- Written informed consent
- Expected R0 resection by laparoscopy
- Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
Key exclusion criteria (13 listed)
- Pregnant and lactating women
- Suffering from a severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- Rejection of laparoscopic resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic resectionLaparoscopic surgery under general anesthesia | Procedure or surgery | Group A (Study group), Group B (Control group) |
Primary outcome
3-year disease free survival rate
Time frame: 36 months
Definition of recurrence and recurrence date The following situations are regarded as "recurrence" 1. Recurrence identified by any one image examination (X-ray, ultrasound, computed tomography, magnetic resonance imaging, etc.) and, if there are a variety of imaging examinations, results without contradiction determined "recurrence". The earliest date that the recurrence is found is defined as the "recurrence date". 2. For cases that lack the use of imaging or a pathological diagnosis, the date of diagnosing the occurrence of clinical recurrence based on clinical history and physical examination is defined as the "recurrence date". 3. For cases without imaging or clinical diagnosis but with a cytology or tissue biopsy pathological diagnosis of recurrence, the earliest date confirmed by cytology or biopsy pathology is considered the "recurrence date". 4. A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse.
17 secondary outcomes
Intraoperative morbidity rates
Time frame: 30 days
Conversion to open surgery rate
Time frame: 30 days
Positive surgical margin rate
Time frame: 30 days
Overall postoperative serious complications rates
Time frame: 30 days
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Overall postoperative morbidity and mortality rates
Time frame: 30 days
Time to first ambulation
Time frame: 30 days
Time to first flatus
Time frame: 30 days
Time to first liquid diet
Time frame: 30 days
Time to first soft diet
Time frame: 30 days
Duration of postoperative hospital stay
Time frame: 30 days
Intraoperative tumor rupture rates
Time frame: 1 day
The variation of album
Time frame: Preoperative 7 days and postoperative 1 and 5 days
The variation of hemoglobin
Time frame: Preoperative 7 days and postoperative 1 and 5 days
The variation of white blood cell count
Time frame: Preoperative 7 days and postoperative 1 and 5 days
The variation of C-reactive protein
Time frame: Preoperative 7 days and postoperative 1 and 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 11034250Pidhorecky I, Cheney RT, Kraybill WG, Gibbs JF. Gastrointestinal stromal tumors: current diagnosis, biologic behavior, and management. Ann Surg Oncol. 2000 Oct;7(9):705-12. doi: 10.1007/s10434-000-0705-6.
- Background: PubMed 20457867Demetri GD, von Mehren M, Antonescu CR, DeMatteo RP, Ganjoo KN, Maki RG, Pisters PW, Raut CP, Riedel RF, Schuetze S, Sundar HM, Trent JC, Wayne JD. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010 Apr;8 Suppl 2(0 2):S1-41; quiz S42-4. doi: 10.6004/jnccn.2010.0116.
- Background: PubMed 12528772Miettinen M, Majidi M, Lasota J. Pathology and diagnostic criteria of gastrointestinal stromal tumors (GISTs): a review. Eur J Cancer. 2002 Sep;38 Suppl 5:S39-51. doi: 10.1016/s0959-8049(02)80602-5.
- Background: PubMed 21207158Karakousis GC, Singer S, Zheng J, Gonen M, Coit D, DeMatteo RP, Strong VE. Laparoscopic versus open gastric resections for primary gastrointestinal stromal tumors (GISTs): a size-matched comparison. Ann Surg Oncol. 2011 Jun;18(6):1599-605. doi: 10.1245/s10434-010-1517-y. Epub 2011 Jan 5.
- Background: PubMed 21552096Melstrom LG, Phillips JD, Bentrem DJ, Wayne JD. Laparoscopic versus open resection of gastric gastrointestinal stromal tumors. Am J Clin Oncol. 2012 Oct;35(5):451-4. doi: 10.1097/COC.0b013e31821954a7.
- Background: PubMed 23793362Koh YX, Chok AY, Zheng HL, Tan CS, Chow PK, Wong WK, Goh BK. A systematic review and meta-analysis comparing laparoscopic versus open gastric resections for gastrointestinal stromal tumors of the stomach. Ann Surg Oncol. 2013 Oct;20(11):3549-60. doi: 10.1245/s10434-013-3051-1. Epub 2013 Jun 21.
- Background: PubMed 23225195Ganai S, Prachand VN, Posner MC, Alverdy JC, Choi E, Hussain M, Waxman I, Patti MG, Roggin KK. Predictors of unsuccessful laparoscopic resection of gastric submucosal neoplasms. J Gastrointest Surg. 2013 Feb;17(2):244-55; discussion 255-6. doi: 10.1007/s11605-012-2095-z. Epub 2012 Dec 8.
- Background: PubMed 23233005De Vogelaere K, Hoorens A, Haentjens P, Delvaux G. Laparoscopic versus open resection of gastrointestinal stromal tumors of the stomach. Surg Endosc. 2013 May;27(5):1546-54. doi: 10.1007/s00464-012-2622-8. Epub 2012 Dec 12.
- Background: PubMed 24763984Bischof DA, Kim Y, Dodson R, Carolina Jimenez M, Behman R, Cocieru A, Blazer DG 3rd, Fisher SB, Squires MH 3rd, Kooby DA, Maithel SK, Groeschl RT, Clark Gamblin T, Bauer TW, Karanicolas PJ, Law C, Quereshy FA, Pawlik TM. Open versus minimally invasive resection of gastric GIST: a multi-institutional analysis of short- and long-term outcomes. Ann Surg Oncol. 2014 Sep;21(9):2941-8. doi: 10.1245/s10434-014-3733-3. Epub 2014 Apr 24.
- Background: PubMed 24853837Lin J, Huang C, Zheng C, Li P, Xie J, Wang J, Lu J. Laparoscopic versus open gastric resection for larger than 5 cm primary gastric gastrointestinal stromal tumors (GIST): a size-matched comparison. Surg Endosc. 2014 Sep;28(9):2577-83. doi: 10.1007/s00464-014-3506-x. Epub 2014 May 23.
- Background: PubMed 24566748Honda M, Hiki N, Nunobe S, Ohashi M, Kiyokawa T, Sano T, Yamaguchi T. Long-term and surgical outcomes of laparoscopic surgery for gastric gastrointestinal stromal tumors. Surg Endosc. 2014 Aug;28(8):2317-22. doi: 10.1007/s00464-014-3459-0. Epub 2014 Feb 25.
- Background: PubMed 24879133Masoni L, Gentili I, Maglio R, Meucci M, D'Ambra G, Di Giulio E, Di Nardo G, Corleto VD. Laparoscopic resection of large gastric GISTs: feasibility and long-term results. Surg Endosc. 2014 Oct;28(10):2905-10. doi: 10.1007/s00464-014-3552-4. Epub 2014 May 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GIST of Stomach and Gastric Cancer, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03716089, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.