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

GIST Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03082079
• Other study ID #: LC2016YM002
• Status: Not yet recruiting
• Phase: N/A
• First received: March 1, 2017
• Last updated: May 14, 2017
• Start date: June 1, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: yue li, Doctor
• Phone: 15975537291
• Email: liyue_1989919[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 30, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• GIST

Intervention

Procedure:
• ESD
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

References & Publications (17)

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. — View 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. Review. — View Citation

Davila RE, Faigel DO. GI stromal tumors. Gastrointest Endosc. 2003 Jul;58(1):80-8. Review. — View 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:S1-41; quiz S42-4. — View 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. Review. — View 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. Erratum in: Ann Oncol. 2015 Sep;26 Suppl 5:v174-7. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. 2016 Feb 24. pii: S1015-9584(16)00002-6. doi: 10.1016/j.asjsur.2015.12.001. [Epub ahead of print] — View Citation

Sornmayura P. Gastrointestinal stromal tumors (GISTs): a pathology view point. J Med Assoc Thai. 2009 Jan;92(1):124-35. Review. — View Citation

Uçar 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. — View 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

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