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

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938309
• Other study ID #: FUGES-029
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: May 1, 2028

Study information

• Verified date: July 2023
• Source: Fujian Medical University
• Contact: Ping Li, MD,PhD
• Phone: +8613365918502
• Email: Pingli811002[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18 years < age < 75 years

2. 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

3. Patient informed consent and willingness to undergo laparoscopic resection

4. Expected laparoscopic outcome of R0 resection

5. Performance status: Eastern Cooperative Oncology Group (ECOG) = 2, Preoperative American Society of Anesthesiologists(ASA) score I-III

Exclusion Criteria:

1. Women during pregnancy or breast-feeding

2. Severe mental disorder

3. History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)

4. History of gastric surgery (except ESD/EMR for gastric cancer)

5. History of other malignant diseases within the past five years

6. History of unstable angina or myocardial infarction within the past six months

7. History of a cerebrovascular accident within the past six months

8. History of continuous systematic administration of corticosteroids within one month

9. Requirement of simultaneous surgery for other diseases

10. Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Locations

Country	Name	City	State
China	Department of Gastric Surgery, Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (11)

Lead Sponsor

Collaborator

Fujian Medical University

900 th Hospital of Joint Logistics 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

Country where clinical trial is conducted

China, 

References & Publications (10)

Bischof 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. — View Citation

De 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. — View Citation

Dematteo RP, Gold JS, Saran L, Gonen M, Liau KH, Maki RG, Singer S, Besmer P, Brennan MF, Antonescu CR. Tumor mitotic rate, size, and location independently predict recurrence after resection of primary gastrointestinal stromal tumor (GIST). Cancer. 2008 Feb 1;112(3):608-15. doi: 10.1002/cncr.23199. — View Citation

Goh BK, Chow PK, Chok AY, Chan WH, Chung YF, Ong HS, Wong WK. Impact of the introduction of laparoscopic wedge resection as a surgical option for suspected small/medium-sized gastrointestinal stromal tumors of the stomach on perioperative and oncologic outcomes. World J Surg. 2010 Aug;34(8):1847-52. doi: 10.1007/s00268-010-0590-5. — View Citation

Goh BK, Goh YC, Eng AK, Chan WH, Chow PK, Chung YF, Ong HS, Wong WK. Outcome after laparoscopic versus open wedge resection for suspected gastric gastrointestinal stromal tumors: A matched-pair case-control study. Eur J Surg Oncol. 2015 Jul;41(7):905-10. doi: 10.1016/j.ejso.2015.04.001. Epub 2015 Apr 15. — View Citation

Joensuu H, Hohenberger P, Corless CL. Gastrointestinal stromal tumour. Lancet. 2013 Sep 14;382(9896):973-83. doi: 10.1016/S0140-6736(13)60106-3. Epub 2013 Apr 24. — View Citation

Khoo CY, Goh BKP, Eng AKH, Chan WH, Teo MCC, Chung AYF, Ong HS, Wong WK. Laparoscopic wedge resection for suspected large (>/=5 cm) gastric gastrointestinal stromal tumors. Surg Endosc. 2017 May;31(5):2271-2279. doi: 10.1007/s00464-016-5229-7. Epub 2016 Sep 8. — View Citation

Park SH, Lee HJ, Kim MC, Yook JH, Sohn TS, Hyung WJ, Ryu SW, Kurokawa Y, Kim YW, Han SU, Kim HH, Park DJ, Kim W, Lee SI, Cho H, Cho GS, Kim JJ, Kim KH, Yoo MW, Yang HK. Early experience of laparoscopic resection and comparison with open surgery for gastric gastrointestinal stromal tumor: a multicenter retrospective study. Sci Rep. 2022 Feb 10;12(1):2290. doi: 10.1038/s41598-022-05044-x. — View Citation

Piessen G, Lefevre JH, Cabau M, Duhamel A, Behal H, Perniceni T, Mabrut JY, Regimbeau JM, Bonvalot S, Tiberio GA, Mathonnet M, Regenet N, Guillaud A, Glehen O, Mariani P, Denost Q, Maggiori L, Benhaim L, Manceau G, Mutter D, Bail JP, Meunier B, Porcheron J, Mariette C, Brigand C; AFC and the FREGAT working group. Laparoscopic Versus Open Surgery for Gastric Gastrointestinal Stromal Tumors: What Is the Impact on Postoperative Outcome and Oncologic Results? Ann Surg. 2015 Nov;262(5):831-9; discussion 829-40. doi: 10.1097/SLA.0000000000001488. — View Citation

von Mehren M, Randall RL, Benjamin RS, Boles S, Bui MM, Casper ES, Conrad EU 3rd, DeLaney TF, Ganjoo KN, George S, Gonzalez RJ, Heslin MJ, Kane JM 3rd, Mayerson J, McGarry SV, Meyer C, O'Donnell RJ, Pappo AS, Paz IB, Pfeifer JD, Riedel RF, Schuetze S, Schupak KD, Schwartz HS, Van Tine BA, Wayne JD, Bergman MA, Sundar H. Gastrointestinal stromal tumors, version 2.2014. J Natl Compr Canc Netw. 2014 Jun;12(6):853-62. doi: 10.6004/jnccn.2014.0080. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall postoperative morbidity	This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.	30 days after surgery or the first discharge ( if over 30 days hospital stay)
Secondary	intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 day
Secondary	Conversion to open surgery rate	Conversion to open surgery rate is defined as the rate of open surgery whatever the reason	1 day
Secondary	Positive surgical margin rate	Positive surgical margin rate	1 day
Secondary	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.	Preoperative 7 days and postoperative 1, 3, and 5 days
Secondary	The variation of hemoglobin	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.	Preoperative 7 days and postoperative 1, 3, and 5 days
Secondary	The variation of C-reactive protein	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	Preoperative 7 days and postoperative 1, 3, and 5 days
Secondary	overall postoperative serious morbidity rates	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.	30 days after surgery or the first discharge ( if over 30 days hospital stay)
Secondary	Time to first ambulation	Time to first ambulation in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first flatus	Time to first flatus in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first liquid diet	Time to first liquid diet in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first soft diet	Time to first soft diet in days is used to assess the postoperative recovery course.	30 days
Secondary	Duration of postoperative hospital stay	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days
Secondary	3-year overall survival rate	3-year overall survival rate	36 months
Secondary	3-year disease free survival rate	3-year disease free survival rate	36 months
Secondary	3-year recurrence pattern	Recurrence patterns are classified into four categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, and mixed type	36 months