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

Официальное название

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

Обзор

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

Подробное описание

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.

Первичные конечные точки

• Overall postoperative morbidity [Срок оценки: 30 days after surgery or the first discharge ( if over 30 days hospital stay)]

Вторичные конечные точки (12)

• intraoperative morbidity rates [Срок оценки: 1 day]
• Conversion to open surgery rate [Срок оценки: 1 day]
• Positive surgical margin rate [Срок оценки: 1 day]
• The variation of white blood cell count [Срок оценки: Preoperative 7 days and postoperative 1, 3, and 5 days]
• The variation of hemoglobin [Срок оценки: Preoperative 7 days and postoperative 1, 3, and 5 days]
• The variation of C-reactive protein [Срок оценки: Preoperative 7 days and postoperative 1, 3, and 5 days]
• overall postoperative serious morbidity rates [Срок оценки: 30 days after surgery or the first discharge ( if over 30 days hospital stay)]
• Time to first ambulation [Срок оценки: 30 days]
• Time to first flatus [Срок оценки: 30 days]
• Time to first liquid diet [Срок оценки: 30 days]
• Time to first soft diet [Срок оценки: 30 days]
• Duration of postoperative hospital stay [Срок оценки: 30 days]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)
• History of other malignant diseases within the past five years
• 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 other diseases
• Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Department of Gastric Surgery， Fujian Medical University Union Hospital — Фучжоу

Публикации

• 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. PMID 23623056
• 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. PMID 18076015
• 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/s104 PMID 24763984
• 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. PMID 23233005
• 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. PMID 25913060
• 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 PMID 24925196
• 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. PMID 20407770
• 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 PMID 26583673

Идентификаторы

NCT: NCT05938309 · FUGES-029

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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