Laparoscopic Resection of Large Gastric Stromal Tumors

NCT02662478 | Completed DMC

• 1 other identifier: MK-006-ST
• Study Type: observational
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite laparoscopic surgical treatment has not been recommended in patients with gastric gastrointestinal stromal tumors (GIST) larger than 5 centimeter, but it continues to evolve rapidly to overcome the boundaries. Therefore the authors generated a morpho-anatomical classification system (MACS) adapted for primary gastric GISTs, by which they could plan to tailor the laparoscopic gastric resection appropriately. 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 MACS for the development a preoperative strategy and the extent to which this strategy overlaps with the reality.

Conditions

Gastrointestinal Stromal Tumors

Keywords

Laparoscopic gastric resection; gastrointestinal stromal tumor; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Success rate

  Laparoscopic surgery performed without conversion to open surgery with a negative surgical margin

  within the first 30 days after surgery

Secondary Outcomes (1)

• Accuracy of classification system

  within the first 3 months after completion of the patient recruitment

Study Arms (1)

primary gastric GIST

Consisted of all consecutive cases of primary gastric stromal tumors (PGST) that underwent laparoscopic surgery (LS).

Procedure: Laparoscopic Surgery

Interventions

Laparoscopic Surgery PROCEDURE

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.

primary gastric GIST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Using the Turkish national procedural classification code number for laparoscopic stomach surgeries, a search was made in the Medical Park Gaziantep Hospital database which identified 124 patients underwent laparoscopic gastric resection for tumor. Then an additional similar search was performed to obtain primary gastric GIST subgroup according to the histopathological results and a total of 23 patients in whom LRS were performed, were identified.

You may qualify if:

• All patients with gastric GIST underwent laparoscopic surgery

You may not qualify if:

• Patients with GIST of other than stomach
• Patients who refused laparoscopic surgery

Sponsors & Collaborators

• Medical Park Gaziantep Hospital: lead
• Bahçeşehir University: collaborator
• Muğla Sıtkı Koçman University: collaborator

Related Publications (4)

• 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.

  PMID: 26618334 BACKGROUND

• 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.

  PMID: 22153892 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.

  PMID: 20457867 BACKGROUND

• 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.

  PMID: 22273319 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

gastric resection material

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mehmet Kaplan, M.D.

  Bahçeşehir Üniversitesi Tıp Fakültesi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 25, 2016
• Study Start: June 1, 2008
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share