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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESD | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| success rate of operations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yue li, Doctor | Contact | 15975537291 | liyue_1989919@126.com |
| Name | Affiliation | Role |
|---|---|---|
| yue li, Doctor | Nanfang Hospital, Southern Medical University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12838226 | Background | Davila RE, Faigel DO. GI stromal tumors. Gastrointest Endosc. 2003 Jul;58(1):80-8. doi: 10.1067/mge.2003.317. No abstract available. | |
| 26922628 | Background | 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. |
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The proportion of the total number of patients with GISTs been successfully resected of each group.
| At surgery |
| Tumor progression rates | The proportion of the total number of patients with tumor continuing to increase of each group. | 5 years |
| Operation time | It is the time that passes from ESD beginning to complete resection of the tumors. | At surgery |
| Peri-operative bleeding | The amount of bleeding during operation. | At surgery |
| Complications rate | Complications including bleeding and perforation. | 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. | 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 | At surgery |
| patient satisfaction scores | We administer questionnaires to each patients,and invite them to score for this treatment or examination. | 5 years |
| 26907871 | Background | 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. |
| 26897944 | Background | 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. |
| 19260254 | Background | Sornmayura P. Gastrointestinal stromal tumors (GISTs): a pathology view point. J Med Assoc Thai. 2009 Jan;92(1):124-35. |
| 25210085 | Background | 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. |
| 26895119 | Background | 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. |
| 16772777 | Background | 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. |
| 18466871 | Background | 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. |
| 24719942 | Background | 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. |
| 20457867 | 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. |
| 22057760 | Background | 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. |
| 24679229 | Background | 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. |
| 26490768 | Background | 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. |
| 26898597 | Background | 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. |
| 26898512 | Background | 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. |
| 26874075 | Background | 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. |