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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Study group) | Group for laparoscopic resection of GIST with unfavorable group (Unfavorable group) |
| |
| Group B (Control group) | Group for laparoscopic resection of GIST with favorable group (favorable group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic resection | Procedure | Laparoscopic surgery under general anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | Definition of recurrence and recurrence date The following situations are regarded as "recurrence"
| 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative morbidity rates |
| 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who meet the inclusion criteria and not conform to the exclusion criteria are qualified for this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11034250 | Background | 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. | |
| 20457867 | Background | Demetri 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. |
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| Conversion to open surgery rate |
| 30 days |
| Positive surgical margin rate |
| 30 days |
| Overall postoperative serious complications rates |
(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. | 30 days |
| 3-year overall survival rate |
| 36 months |
| 3-year recurrence pattern | Definition of recurrence and recurrence date The following situations are regarded as "recurrence"
| 36 months |
| Overall postoperative morbidity and mortality rates |
| 30 days |
| Time to first ambulation | Time to first ambulation in hours is used to assess the postoperative recovery course. | 30 days |
| Time to first flatus | Time to first flatus in days is used to assess the postoperative recovery course. | 30 days |
| Time to first liquid diet | Time to first liquid diet in days is used to assess the postoperative recovery course. | 30 days |
| Time to first soft diet | Time to first soft diet in days is used to assess the postoperative recovery course. | 30 days |
| Duration of postoperative hospital stay | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days |
| Intraoperative tumor rupture rates | Intraoperative tumor rupture rates are used to access the oncological safety of the intervention. | 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. | 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. | 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. | 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. | Preoperative 7 days and postoperative 1 and 5 days |
| 12528772 | Background | Miettinen 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. |
| 21207158 | Background | Karakousis 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. |
| 21552096 | Background | Melstrom 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. |
| 23793362 | Background | Koh 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. |
| 23225195 | Background | Ganai 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. |
| 23233005 | Background | 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. |
| 24763984 | Background | 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. |
| 24853837 | Background | Lin 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. |
| 24566748 | Background | Honda 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. |
| 24879133 | Background | Masoni 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. |
| 25052129 | Background | Hsiao 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. |
| 25005014 | Background | Chen 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. |
| 26169640 | Background | Dressler 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. |
| 16502196 | Background | Nguyen SQ, Divino CM, Wang JL, Dikman SH. Laparoscopic management of gastrointestinal stromal tumors. Surg Endosc. 2006 May;20(5):713-6. doi: 10.1007/s00464-005-0435-8. Epub 2006 Feb 21. |
| 24729813 | Background | Poskus E, Petrik P, Petrik E, Lipnickas V, Stanaitis J, Strupas K. Surgical management of gastrointestinal stromal tumors: a single center experience. Wideochir Inne Tech Maloinwazyjne. 2014 Mar;9(1):71-82. doi: 10.5114/wiitm.2014.40987. Epub 2014 Feb 26. |
| 28383420 | Background | Huang CM, Chen QF, Lin JX, Lin M, Zheng CH, Li P, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Tu RH. Can laparoscopic surgery be applied in gastric gastrointestinal stromal tumors located in unfavorable sites?: A study based on the NCCN guidelines. Medicine (Baltimore). 2017 Apr;96(14):e6535. doi: 10.1097/MD.0000000000006535. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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