Study Results
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Basic Information
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COMPLETED
23 participants
OBSERVATIONAL
2008-06-30
2016-02-29
Brief Summary
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Detailed Description
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Considering these properties of the tumor, the goals of surgery for primary gastric GIST are handling the tumor with great care to avoid tumor rupture as well as performing a complete resection with a negative surgical margin and preserving the organ function as much as possible. This can be accomplished by the traditional open, or more recently by the various total or hybrid laparoscopic techniques. Despite laparoscopic surgical treatment of the GISTs had not been recommended owing to the higher risk of tumor rupture and subsequent peritoneal seeding in consensus meetings in the United States and Europe in 2004 and 2005 respectively, it has experienced a rapid and major evolutionary process and currently it is being advised to be a standard approach for gastric GISTs irrespective of its size or location.
In addition to achieve an R0 resection without a tear in the tumor, the most important issue for the laparoscopic gastric GIST surgery is the preserving the function and not to cause a stenosis in the stomach as much as possible. According to the morphologic characteristics of the tumor and the area in the three-dimensional anatomical configuration of the stomach that involved by the tumor, a lot of laparoscopic surgical scenarios can be produced. Among them, to achieve the best alternative which meets all above criteria the authors generated a morpho-anatomical classification system by which they could plan preoperatively to tailor the gastric resection and all operational requirements. This system was partly inspired by the TNM classification for GISTs and Japanese classification of gastric carcinoma, has long been used in authors' institution when planning a laparoscopic intervention for various gastric lesions in patients in whom an appropriate preoperative patient evaluation is needed. It is then specifically composed and standardized to adapt for primary gastric GISTs and it was being used for large tumors up to 10 cm.
The aims of the study was to demonstrate the feasibility of laparoscopic surgery for primary gastric GISTs larger than 5 cm, to find out the accuracy and practicality of the classification system in the development a preoperative strategy and the extent to which this strategy overlaps with the reality.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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primary gastric GIST
Consisted of all consecutive cases of primary gastric stromal tumors (PGST) that underwent laparoscopic surgery (LS).
Laparoscopic Surgery
Mid-point between the xiphoid and umbilicus was used to the entrance site of the telescope. Open trocar insertion was used in patients with history of open upper abdominal surgery; otherwise Veress needle established CO2 insufflations. The number, size and entry points of the other trocars were tailored according to the tumor location and size. In general, 2 to 4 additional trocars were used. All specimens were taken out of the abdomen through a suprapubic transverse incision in a sterile bag. Resection technique was determined by the size, number, location of the lesion, and surgical anatomy of the stomach. Lymph node dissection was not done as it is unnecessary.
Interventions
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Laparoscopic Surgery
Mid-point between the xiphoid and umbilicus was used to the entrance site of the telescope. Open trocar insertion was used in patients with history of open upper abdominal surgery; otherwise Veress needle established CO2 insufflations. The number, size and entry points of the other trocars were tailored according to the tumor location and size. In general, 2 to 4 additional trocars were used. All specimens were taken out of the abdomen through a suprapubic transverse incision in a sterile bag. Resection technique was determined by the size, number, location of the lesion, and surgical anatomy of the stomach. Lymph node dissection was not done as it is unnecessary.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who refused laparoscopic surgery
18 Years
ALL
No
Sponsors
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Bahçeşehir University
OTHER
Muğla Sıtkı Koçman University
OTHER
Medical Park Gaziantep Hospital
OTHER
Responsible Party
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Mehmet Kaplan
General Surgery
Principal Investigators
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Mehmet Kaplan, M.D.
Role: STUDY_DIRECTOR
Bahçeşehir Üniversitesi Tıp Fakültesi
References
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Soreide K, Sandvik OM, Soreide JA, Giljaca V, Jureckova A, Bulusu VR. Global epidemiology of gastrointestinal stromal tumours (GIST): A systematic review of population-based cohort studies. Cancer Epidemiol. 2016 Feb;40:39-46. doi: 10.1016/j.canep.2015.10.031. Epub 2015 Nov 24.
Joensuu H, Vehtari A, Riihimaki J, Nishida T, Steigen SE, Brabec P, Plank L, Nilsson B, Cirilli C, Braconi C, Bordoni A, Magnusson MK, Linke Z, Sufliarsky J, Federico M, Jonasson JG, Dei Tos AP, Rutkowski P. Risk of recurrence of gastrointestinal stromal tumour after surgery: an analysis of pooled population-based cohorts. Lancet Oncol. 2012 Mar;13(3):265-74. doi: 10.1016/S1470-2045(11)70299-6. Epub 2011 Dec 6.
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.
Han D, Deneve J, Gonzalez RJ. Recurrence risk after resection of gastrointestinal stromal tumors: size is not all that matters... The consequences of tumor rupture. Am Surg. 2012 Jan;78(1):74-9.
Other Identifiers
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MK-006-ST
Identifier Type: -
Identifier Source: org_study_id
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