GISTNCT03082079

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

A study testing ESD in people with GIST, run by Nanfang Hospital, Southern Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: GIST
What is being tested?: ESD
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: No sites listed yet
Study dates: 1 Jun 2017to 30 Sep 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

No sites are listed yet.

yue li, Doctor contact

15975537291

liyue_1989919@126.com

About this study

Official title: Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm) :a Randomized Controlled Trial

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.

Read the 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.

Conditions: GIST
Being tested: ESD
Keywords: GIST, ESD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ESDProcedure or surgery
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

Study groups in NCT03082079
Study group	Role	What they receive
ESD group	Experimental	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. Receives: Procedure: ESD
Follow-up group	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 years

Secondary outcomes (9)

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.
Measured: 5 years
success rate of operations
The proportion of the total number of patients with GISTs been successfully resected of each group.
Measured: At surgery
Tumor progression rates
The proportion of the total number of patients with tumor continuing to increase of each group.
Measured: 5 years
Operation time
It is the time that passes from ESD beginning to complete resection of the tumors.
Measured: At surgery
Peri-operative bleeding
The amount of bleeding during operation.
Measured: At surgery
Complications rate
Complications including bleeding and perforation.
Measured: At surgery
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.
Measured: through the whole recovery, an average of 10 days
Histological curative resection
Histological curative resection is defined as complete tumor removal which confirmed by pathological assessment of resected tissue
Measured: At surgery
patient satisfaction scores
We administer questionnaires to each patients,and invite them to score for this treatment or examination.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201730 Sep 2021

First posted17 Mar 2017
Study start1 Jun 2017 (estimated)
Primary completion1 Aug 2021 (estimated)
Study completion30 Sep 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for GISTStudies of the same condition, open and under way.
More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03082079
Sponsor's protocol ID: LC2016YM002
Status last verified: Feb 2017
First submitted: 1 Mar 2017
Last updated: 16 May 2017
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Davila RE, Faigel DO. GI stromal tumors. Gastrointest Endosc. 2003 Jul;58(1):80-8. doi: 10.1067/mge.2003.317. No abstract available.
PubMed 12838226
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.
PubMed 26922628
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.
PubMed 26907871
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.
PubMed 26897944
Sornmayura P. Gastrointestinal stromal tumors (GISTs): a pathology view point. J Med Assoc Thai. 2009 Jan;92(1):124-35.
PubMed 19260254
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.
PubMed 25210085
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.
PubMed 26895119
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.
PubMed 16772777
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.
PubMed 18466871
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.
PubMed 24719942
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.
PubMed 20457867
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.
PubMed 22057760
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.
PubMed 24679229
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.
PubMed 26490768
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.
PubMed 26898597

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm) :a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03082079
Acronym / sponsor ID: LC2016YM002
Conditions: GIST
Keywords: GIST, ESD
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 90 participants (estimated)
Lead sponsor: Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
Study start: 1 Jun 2017 (estimated)
Primary completion: 1 Aug 2021 (estimated)
Study completion: 30 Sep 2021 (estimated)
First posted: 17 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ESD group	Experimental	Procedure: ESDPatient 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.
Follow-up group	No intervention	–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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ESDPatient 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	Procedure or surgery	ESD group

Primary outcome

progression-free survival
Time frame: 5 years
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.

9 secondary outcomes

tumor recurrence rate
Time frame: 5 years
success rate of operations
Time frame: At surgery
Tumor progression rates
Time frame: 5 years
Operation time
Time frame: At surgery
Peri-operative bleeding
Time frame: At surgery
Complications rate
Time frame: At surgery
Duration of hospitalization and the total hospital costs
Time frame: through the whole recovery, an average of 10 days
Histological curative resection
Time frame: At surgery
patient satisfaction scores
Time frame: 5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
Background: PubMed 12838226Davila RE, Faigel DO. GI stromal tumors. Gastrointest Endosc. 2003 Jul;58(1):80-8. doi: 10.1067/mge.2003.317. No abstract available.
Background: PubMed 26922628Siow 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.
Background: PubMed 26907871Reichardt P. [Soft tissue sarcomas and gastrointestinal stromal tumors]. Internist (Berl). 2016 Mar;57(3):245-56. doi: 10.1007/s00108-016-0021-2. German.
Background: PubMed 26897944Ucar 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.
Background: PubMed 19260254Sornmayura P. Gastrointestinal stromal tumors (GISTs): a pathology view point. J Med Assoc Thai. 2009 Jan;92(1):124-35.
Background: PubMed 25210085ESMO/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.
Background: PubMed 26895119Maghrebi 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.
Background: PubMed 16772777Novitsky 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.
Background: PubMed 18466871Nakamori 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.
Background: PubMed 24719942Matsuhashi 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.
Background: PubMed 20457867Demetri 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.
Background: PubMed 22057760Deprez 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

yue li, Doctor contact

15975537291

liyue_1989919@126.com

yue li, Doctor study chair

Nanfang Hospital, Southern Medical University

Questions about this trial

What is this clinical trial studying?

A study testing ESD in people with GIST, run by Nanfang Hospital, Southern Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yue li, Doctor (15975537291, liyue_1989919@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03082079, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.