- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02662478
Laparoscopic Resection of Large Gastric Stromal Tumors
Accuracy and Feasibility of a Morpho-anatomical Classification Oriented Laparoscopic Resection of Gastric Stromal Tumors in Advanced Laparoscopic Surgery Center: a Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Incidence rate of gastrointestinal stromal tumors (GIST) is 10-15 per million per year. Although very rare, it is the most common mesenchymal tumor of the gastrointestinal tract, and the stomach is the most common affected organ with up to 55.6%. Despite recent drug discoveries have greatly impacted the treatment, complete surgical resection with adequate safety margin is still the only potentially curative treatment for primary gastric GIST with no evidence of metastasis. As sarcomas in general, most GISTs also metastasize hematogenously to the liver, disseminate peritoneally, and rarely show lymph node metastasis, therefore systematic or prophylactic lymph node dissection is usually unnecessary; a pick-up sampling is considered sufficient when a perilesional lymph node enlargement is found. In addition to that, these tumors tend to be soft and friable. Therefore pseudocapsule may be tearing spontaneously or inadvertently during surgery and tumor cells can be disseminating intraperitoneally which results in increased risk for recurrence and decreased survival.
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients with gastric GIST underwent laparoscopic surgery
Exclusion Criteria:
- Patients with GIST of other than stomach
- Patients who refused laparoscopic surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
primary gastric GIST
Consisted of all consecutive cases of primary gastric stromal tumors (PGST) that underwent laparoscopic surgery (LS).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate
Time Frame: within the first 30 days after surgery
|
Laparoscopic surgery performed without conversion to open surgery with a negative surgical margin
|
within the first 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of classification system
Time Frame: within the first 3 months after completion of the patient recruitment
|
the rate of overlapping preoperative strategy with the postoperative reality
|
within the first 3 months after completion of the patient recruitment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MK-006-ST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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