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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05938309
Other study ID # FUGES-029
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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