search
Back to results

Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm)

Primary Purpose

GIST

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ESD
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GIST focused on measuring GIST, ESD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female chinese patients of 18-70 years old.
  2. Patients with very small gastric GISTs (< 2 cm) with no high-risk EUS features.
  3. Patients voluntarily join this study with informed consents.

Exclusion Criteria:

  1. Patients with the tumors involving the serosa layer or grow outside the lumen obviously that are not eligible for endoscopic treatment.
  2. Patients with distant metastasis on computed tomography(CT)scan.
  3. patients with an extremely poor general condition or a very short life expectancy.
  4. Patients presenting with severe gastrointestinal tract bleeding that require immediate surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ESD group

    Follow-up group

    Arm Description

    Patient in this group undergo ESD for GIST, and regular follow-up are carried out for these patients on 72 ±3h,7±2d,14±2d,3 month,6 month,1 year,2 year,3 year,4 year,5 year after the treatment. The investigators record the success rate of operation,en bloc resection,operation time,complication rate,hospitalization days,hospitalization expenses,pathology results and tumor recurrence rate.

    Patient in this group are given no intervention,the investigators record the tumor size and EUS features of the first endoscopic examination.Regular follow-up are carried out for these patients on 3 month,6 month,1 year,2 year,3 year,4 year,5 year after this check.Then,tumor size and EUS features of each time are collected accurately.

    Outcomes

    Primary Outcome Measures

    progression-free survival
    It is the time that passes from a patient is enrolled in this clinical trial to the date on which disease "progresses" or the date on which the patient dies, from any cause.

    Secondary Outcome Measures

    tumor recurrence rate
    The proportion of the total number of patients with recurrence of each grop, which confirmed by endoscopic and other imaging data during follow-up.
    success rate of operations
    The proportion of the total number of patients with GISTs been successfully resected of each group.
    Tumor progression rates
    The proportion of the total number of patients with tumor continuing to increase of each group.
    Operation time
    It is the time that passes from ESD beginning to complete resection of the tumors.
    Peri-operative bleeding
    The amount of bleeding during operation.
    Complications rate
    Complications including bleeding and perforation.
    Duration of hospitalization and the total hospital costs
    length of hospital stay and all costs related to the operations and examinations and the period of hospitalization.
    Histological curative resection
    Histological curative resection is defined as complete tumor removal which confirmed by pathological assessment of resected tissue
    patient satisfaction scores
    We administer questionnaires to each patients,and invite them to score for this treatment or examination.

    Full Information

    First Posted
    March 1, 2017
    Last Updated
    May 14, 2017
    Sponsor
    Nanfang Hospital, Southern Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03082079
    Brief Title
    Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm)
    Official Title
    Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm) :a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2017 (Anticipated)
    Primary Completion Date
    August 1, 2021 (Anticipated)
    Study Completion Date
    September 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanfang Hospital, Southern Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Data are currently insufficient to guide the management of very small gastrointestinal stromal tumors（GISTs）（< 2 cm) discovered incidentally on endoscopy,this study is designed to collect the medical records of patients in different treatment group with long-term follow-up data,and attempts to evaluate the usefulness of regular endoscopic ultrasound（EUS）surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（ESD）for small GISTs,thus provide evidence for the revision of the guideline.
    Detailed Description
    OBJECTION:to evaluate the usefulness of regular endoscopic ultrasound（EUS） surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（ESD） for small GISTs(<2cm),thus providing evidences for the revision of the guideline. OUTLINE:This is a randomized controlled trial. Eligible patients are divided into 2 group with 45 in each.The experimental group undergo ESD for GISTs,while the investigators do no treatment to the control group.Then,the 2 groups will be follow up for 5 years.All data are analysed with the Statistical Product and Service Solutions（SPSS）statistical software.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    GIST
    Keywords
    GIST, ESD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESD group
    Arm Type
    Experimental
    Arm Description
    Patient in this group undergo ESD for GIST, and regular follow-up are carried out for these patients on 72 ±3h,7±2d,14±2d,3 month,6 month,1 year,2 year,3 year,4 year,5 year after the treatment. The investigators record the success rate of operation,en bloc resection,operation time,complication rate,hospitalization days,hospitalization expenses,pathology results and tumor recurrence rate.
    Arm Title
    Follow-up group
    Arm Type
    No Intervention
    Arm Description
    Patient in this group are given no intervention,the investigators record the tumor size and EUS features of the first endoscopic examination.Regular follow-up are carried out for these patients on 3 month,6 month,1 year,2 year,3 year,4 year,5 year after this check.Then,tumor size and EUS features of each time are collected accurately.
    Intervention Type
    Procedure
    Intervention Name(s)
    ESD
    Intervention Description
    Patient in ESD group undergo ESD for GIST, and regular follow-up are carried out for these patients on 72 ±3h,7±2d,14±2d,3 month,6 month,1 year,2 year,3 year,4 year,5 year after the treatment. The investigators record the success rate of operation,en bloc resection,operation time,complication rate,hospitalization days,hospitalization expenses,pathology results and tumor recurrence rate
    Primary Outcome Measure Information:
    Title
    progression-free survival
    Description
    It is the time that passes from a patient is enrolled in this clinical trial to the date on which disease "progresses" or the date on which the patient dies, from any cause.
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    tumor recurrence rate
    Description
    The proportion of the total number of patients with recurrence of each grop, which confirmed by endoscopic and other imaging data during follow-up.
    Time Frame
    5 years
    Title
    success rate of operations
    Description
    The proportion of the total number of patients with GISTs been successfully resected of each group.
    Time Frame
    At surgery
    Title
    Tumor progression rates
    Description
    The proportion of the total number of patients with tumor continuing to increase of each group.
    Time Frame
    5 years
    Title
    Operation time
    Description
    It is the time that passes from ESD beginning to complete resection of the tumors.
    Time Frame
    At surgery
    Title
    Peri-operative bleeding
    Description
    The amount of bleeding during operation.
    Time Frame
    At surgery
    Title
    Complications rate
    Description
    Complications including bleeding and perforation.
    Time Frame
    At surgery
    Title
    Duration of hospitalization and the total hospital costs
    Description
    length of hospital stay and all costs related to the operations and examinations and the period of hospitalization.
    Time Frame
    through the whole recovery, an average of 10 days
    Title
    Histological curative resection
    Description
    Histological curative resection is defined as complete tumor removal which confirmed by pathological assessment of resected tissue
    Time Frame
    At surgery
    Title
    patient satisfaction scores
    Description
    We administer questionnaires to each patients,and invite them to score for this treatment or examination.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female chinese patients of 18-70 years old. Patients with very small gastric GISTs (< 2 cm) with no high-risk EUS features. Patients voluntarily join this study with informed consents. Exclusion Criteria: Patients with the tumors involving the serosa layer or grow outside the lumen obviously that are not eligible for endoscopic treatment. Patients with distant metastasis on computed tomography(CT)scan. patients with an extremely poor general condition or a very short life expectancy. Patients presenting with severe gastrointestinal tract bleeding that require immediate surgery.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    yue li, Doctor
    Phone
    15975537291
    Email
    liyue_1989919@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    yue li, Doctor
    Organizational Affiliation
    Nanfang Hospital, Southern Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    12838226
    Citation
    Davila RE, Faigel DO. GI stromal tumors. Gastrointest Endosc. 2003 Jul;58(1):80-8. doi: 10.1067/mge.2003.317. No abstract available.
    Results Reference
    background
    PubMed Identifier
    26922628
    Citation
    Siow SL, Mahendran HA, Wong CM. Laparoscopic transgastric resection for intraluminal gastric gastrointestinal stromal tumors located at the posterior wall and near the gastroesophageal junction. Asian J Surg. 2017 Sep;40(5):407-414. doi: 10.1016/j.asjsur.2015.12.001. Epub 2016 Feb 24.
    Results Reference
    background
    PubMed Identifier
    26907871
    Citation
    Reichardt P. [Soft tissue sarcomas and gastrointestinal stromal tumors]. Internist (Berl). 2016 Mar;57(3):245-56. doi: 10.1007/s00108-016-0021-2. German.
    Results Reference
    background
    PubMed Identifier
    26897944
    Citation
    Ucar AD, Oymaci E, Carti EB, Yakan S, Vardar E, Erkan N, Mehmet Y. Characteristics of Emergency Gastrointestinal Stromal Tumor (GIST). Hepatogastroenterology. 2015 May;62(139):635-40.
    Results Reference
    background
    PubMed Identifier
    19260254
    Citation
    Sornmayura P. Gastrointestinal stromal tumors (GISTs): a pathology view point. J Med Assoc Thai. 2009 Jan;92(1):124-35.
    Results Reference
    background
    PubMed Identifier
    25210085
    Citation
    ESMO/European Sarcoma Network Working Group. Gastrointestinal stromal tumours: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii21-6. doi: 10.1093/annonc/mdu255. No abstract available. Erratum In: Ann Oncol. 2015 Sep;26 Suppl 5:v174-7.
    Results Reference
    background
    PubMed Identifier
    26895119
    Citation
    Maghrebi H, Chebbi F, Makni A, Haddad A, Daghfous A, Fteriche F, Rebai W, Ksantini R, Jouini M, Kacem M, Ben Safta Z. Laparoscopic resection of gastric stromal tumors. Tunis Med. 2015 Oct;93(10):594-7.
    Results Reference
    background
    PubMed Identifier
    16772777
    Citation
    Novitsky YW, Kercher KW, Sing RF, Heniford BT. Long-term outcomes of laparoscopic resection of gastric gastrointestinal stromal tumors. Ann Surg. 2006 Jun;243(6):738-45; discussion 745-7. doi: 10.1097/01.sla.0000219739.11758.27.
    Results Reference
    background
    PubMed Identifier
    18466871
    Citation
    Nakamori M, Iwahashi M, Nakamura M, Tabuse K, Mori K, Taniguchi K, Aoki Y, Yamaue H. Laparoscopic resection for gastrointestinal stromal tumors of the stomach. Am J Surg. 2008 Sep;196(3):425-9. doi: 10.1016/j.amjsurg.2007.10.012. Epub 2008 May 7.
    Results Reference
    background
    PubMed Identifier
    24719942
    Citation
    Matsuhashi N, Osada S, Yamaguchi K, Okumura N, Tanaka Y, Imai H, Sasaki Y, Nonaka K, Takahashi T, Futamura M, Yoshida K. Long-term outcomes of treatment of gastric gastrointestinal stromal tumor by laparoscopic surgery: review of the literature and our experience. Hepatogastroenterology. 2013 Nov-Dec;60(128):2011-5.
    Results Reference
    background
    PubMed Identifier
    20457867
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22057760
    Citation
    Deprez PH. Endoscopic diagnosis and treatment of upper gastrointestinal tumors. Endoscopy. 2011 Nov;43(11):966-70. doi: 10.1055/s-0031-1291427. Epub 2011 Nov 4.
    Results Reference
    background
    PubMed Identifier
    24679229
    Citation
    Goto O, Uraoka T, Horii J, Yahagi N. Expanding indications for ESD: submucosal disease (SMT/carcinoid tumors). Gastrointest Endosc Clin N Am. 2014 Apr;24(2):169-81. doi: 10.1016/j.giec.2013.11.006. Epub 2014 Jan 25.
    Results Reference
    background
    PubMed Identifier
    26490768
    Citation
    Meng Y, Cao C, Song S, Li Y, Liu S. Endoscopic band ligation versus endoscopic submucosal dissection and laparoscopic resection for small gastric stromal tumors. Surg Endosc. 2016 Jul;30(7):2873-8. doi: 10.1007/s00464-015-4571-5. Epub 2015 Oct 21.
    Results Reference
    background
    PubMed Identifier
    26898597
    Citation
    Bang CS, Baik GH, Shin IS, Suk KT, Yoon JH, Kim DJ. Endoscopic submucosal dissection of gastric subepithelial tumors: a systematic review and meta-analysis. Korean J Intern Med. 2016 Sep;31(5):860-71. doi: 10.3904/kjim.2015.093. Epub 2016 Feb 22.
    Results Reference
    background
    PubMed Identifier
    26898512
    Citation
    Cho JW; Korean ESD Study Group. Current Guidelines in the Management of Upper Gastrointestinal Subepithelial Tumors. Clin Endosc. 2016 May;49(3):235-40. doi: 10.5946/ce.2015.096. Epub 2016 Feb 22.
    Results Reference
    background
    PubMed Identifier
    26874075
    Citation
    Zhang Q, Li Y, Meng Y, Bai Y, Cai JQ, Han ZL, Wang Z, Zhi FC, Liu SD. Should the Integrity of Mucosa Be Considered in Endoscopic Resection of Gastric Submucosal Tumors? Gastroenterology. 2016 Apr;150(4):822-4.e9. doi: 10.1053/j.gastro.2016.01.040. Epub 2016 Feb 11. No abstract available.
    Results Reference
    background

    Learn more about this trial

    Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm)

    We'll reach out to this number within 24 hrs