Endoscopic Ultrasound Radiofrequency Ablation for GISTs

NCT05453292 | Unknown

• 1 other identifier: IECED-05072022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays, for the selection of the treatment for gastrointestinal stromal tumors (GISTs), tumor size, prognosis, resectability and stage should be considered. Due to mutations in KIT and platelet-derived growth factor alpha (PDGFRA) in 90% of patients with this mesenchymal tumor, many tyrosine kinase inhibitors are used. On the other hand, a resectable tumor is approached by surgery, endoscopic and ablation therapy. Radiofrequency ablation (RFA) approach has been studied in hepatic GISTs, and hepatic metastases, but its evaluation in esophageal, gastric, and intestinal GISTs is scarce. This study aims to determine the feasibility, safety and efficacy of endoscopic ultrasound (EUS) guided RFA using the 19 G RFA probe developed by Taewong Medical for the treatment of GISTs.

Conditions

Gastrointestinal Stromal Tumor (GIST)

Keywords

Gastrointestinal stromal tumor; Radiofrequency; Endosonography

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  Incidence of adverse events of EUS guided RFA for GISTs' lesions and metastasis. Data will be summarized as frequencies and relative frequencies.

  up to 6 months

• Technical success of RFA of GISTs lesions and metastasis

  The technical success will be assessed by completion of ablation on EUS by the time of the procedure, indicated by replacement of the lesion by structural/appearance changes on DFI and CE-EUS Data will be summarized as frequencies.

  up to 2 hours

• Disease-free survival

  Will be assessed by measuring the proportion of patients demonstrating absence of residual tumor on follow-up. CT- scan and DFI at one, three and six months will be performed to evaluate tumor response to the treatment. Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% confidence intervals.

  up to 6 months

Secondary Outcomes (1)

• Re-treatment rate

  1-month

Study Arms (1)

EUS guided RFA

EXPERIMENTAL

This group is comprised by patients with diagnosis of resectable GISTs with/without liver metastasis. The patients included are naïve (without previous treatment) or patients with stable/progressive disease following systemic therapy with tyrosine kinase inhibitors.

Procedure: Endoscopic ultrasound guided radiofrequency ablation

Interventions

Endoscopic ultrasound guided radiofrequency ablation PROCEDURE

Patients will be first assessed by DFI-EUS and CE-EUS. Then. EUS guided RFA will be performed using the 19G electrode ablation needle connected to the Starmed radiofrequency generator (Taewong Medical, Seoul, South Korea). After EUS identification of the GIST, a place without interposing vessels will be found by the endosonographer. Puncture of the tumor will be performed directly with the ablation probe inserted through the working channel of the echoendoscope. Time - seconds will depend by the tumor dimension, localization, distance from vital structures (e.g., aorta) and EUS appearance (e.g., hyperechoic). Power will be set at no more than 30W. If the tumor is in contact with vital structures a 10mm safe margin will be kept from these to avoid thermal injury. Multiple applications can be performed in the same or separate session depending on the residual tumor tissue evaluated with DFI-EUSor CE-EUS immediately after procedure.

EUS guided RFA

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\> 18 years of age)
• Confirmed resectable GISTs lesions in esophagus, stomach, and intestine (between 2\<5 cm or 5-10cm and \<5mitotes/HPF)
• Non-amenable to surgery
• written informed consent
• No evidence of metastatic disease on imaging of the chest abdomen and pelvis contrast enhanced computed tomography (CE-CT) or limited liver metastatic disease (maximum 5 lesions \<= 3 cm)
• Adequate renal, hepatic, and hematological function

You may not qualify if:

• Pregnancy
• Rectal GISTs
• Altered renal, hepatic, or hematological function
• Inability to provide informed consent
• Patients with cardiac pacemakers or other implanted electronic devices and/or electrodes
• Patients that have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome or any condition that contraindicates the procedure
• Inability to tolerate general anesthesia.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Guayaquil, Guayas, 090505, Ecuador

RECRUITING

Related Publications (7)

• Farag S, Smith MJ, Fotiadis N, Constantinidou A, Jones RL. Revolutions in treatment options in gastrointestinal stromal tumours (GISTs): the latest updates. Curr Treat Options Oncol. 2020 May 27;21(7):55. doi: 10.1007/s11864-020-00754-8.

  PMID: 32462367 BACKGROUND

• Casali PG, Blay JY, Abecassis N, Bajpai J, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Boye K, Brodowicz T, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dufresne A, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Frezza AM, Gasperoni S, Gelderblom H, Gouin F, Grignani G, Haas R, Hassan AB, Hindi N, Hohenberger P, Joensuu H, Jones RL, Jungels C, Jutte P, Kasper B, Kawai A, Kopeckova K, Krakorova DA, Le Cesne A, Le Grange F, Legius E, Leithner A, Lopez-Pousa A, Martin-Broto J, Merimsky O, Messiou C, Miah AB, Mir O, Montemurro M, Morosi C, Palmerini E, Pantaleo MA, Piana R, Piperno-Neumann S, Reichardt P, Rutkowski P, Safwat AA, Sangalli C, Sbaraglia M, Scheipl S, Schoffski P, Sleijfer S, Strauss D, Strauss SJ, Hall KS, Trama A, Unk M, van de Sande MAJ, van der Graaf WTA, van Houdt WJ, Frebourg T, Gronchi A, Stacchiotti S; ESMO Guidelines Committee, EURACAN and GENTURIS. Electronic address: clinicalguidelines@esmo.org. Gastrointestinal stromal tumours: ESMO-EURACAN-GENTURIS Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2022 Jan;33(1):20-33. doi: 10.1016/j.annonc.2021.09.005. Epub 2021 Sep 21. No abstract available.

  PMID: 34560242 BACKGROUND

• Yamashita Y, Yoshikawa T, Kawaji Y, Tamura T, Hatamaru K, Itonaga M, Ida Y, Maekita T, Iguchi M, Murata SI, Kitano M. Novel endoscopic ultrasonography imaging technique for visualizing microcirculation without contrast enhancement in subepithelial lesions: Prospective study. Dig Endosc. 2021 Sep;33(6):955-961. doi: 10.1111/den.13889. Epub 2020 Dec 23.

  PMID: 33145842 BACKGROUND

• Yamashita Y, Yoshikawa T, Yamazaki H, Kawaji Y, Tamura T, Hatamaru K, Itonaga M, Ashida R, Ida Y, Maekita T, Iguchi M, Kitano M. A Novel Endoscopic Ultrasonography Imaging Technique for Depicting Microcirculation in Pancreatobiliary Lesions without the Need for Contrast-Enhancement: A Prospective Exploratory Study. Diagnostics (Basel). 2021 Oct 30;11(11):2018. doi: 10.3390/diagnostics11112018.

  PMID: 34829364 BACKGROUND

• Granata V, Grassi R, Fusco R, Setola SV, Palaia R, Belli A, Miele V, Brunese L, Grassi R, Petrillo A, Izzo F. Assessment of Ablation Therapy in Pancreatic Cancer: The Radiologist's Challenge. Front Oncol. 2020 Nov 27;10:560952. doi: 10.3389/fonc.2020.560952. eCollection 2020.

  PMID: 33330028 BACKGROUND

• Robles-Medranda C, Arevalo-Mora M, Oleas R, Alcivar-Vasquez J, Del Valle R. Novel EUS-guided microwave ablation of an unresectable pancreatic neuroendocrine tumor. VideoGIE. 2022 Jan 19;7(2):74-76. doi: 10.1016/j.vgie.2021.10.009. eCollection 2022 Feb.

  PMID: 35146230 BACKGROUND

• Yamanaka T, Takaki H, Nakatsuka A, Uraki J, Fujimori M, Hasegawa T, Sakuma H, Yamakado K. Radiofrequency ablation for liver metastasis from gastrointestinal stromal tumor. J Vasc Interv Radiol. 2013 Mar;24(3):341-6. doi: 10.1016/j.jvir.2012.11.021. Epub 2013 Jan 24.

  PMID: 23352855 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

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

Study Officials

• Carlos Robles-Medranda, MD FASGE

  Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Robles-Medranda, MD FASGE

CONTACT

+59342109180; carlosoakm@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Endoscopy Division

Model Details: A non-blinded, single center, non-randomized prospective feasibility trial.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 12, 2022
• Study Start: January 15, 2024
• Primary Completion: July 15, 2024
• Study Completion: September 15, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

EC (1)