A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
NCT ID: NCT05938309
Last Updated: 2023-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
194 participants
OBSERVATIONAL
2023-05-01
2028-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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large group
laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors
No interventions assigned to this group
small group
laparoscopic resection of less than 5cm gastric gastrointestinal stromal tumors
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Fujian Provincial Hospital
OTHER
Fujian Cancer Hospital
OTHER_GOV
First Affiliated Hospital of Fujian Medical University
OTHER
900 Hospital of Joint Logistics Support Force of PLA
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
The Second Affiliated Hospital of Fujian Medical University
OTHER
The First Hospital of Putian City
UNKNOWN
The Affiliated Hospital(Group) of Putian University
UNKNOWN
Zhangzhou Municipal Hospital of Fujian Province
OTHER
Longyan City First Hospital
OTHER
Fujian Medical University
OTHER
Responsible Party
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Chang-Ming Huang, Prof.
Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor
Locations
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Department of Gastric Surgery， Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FUGES-029
Identifier Type: -
Identifier Source: org_study_id
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