Clinical trial · Interventional

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

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

NCT03082079CI-TRIAL-00027585unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
GIST	Gastrointestinal Stromal Tumor	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
ESD	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
ESD group
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.
interventionNames
1. Procedure: ESD
type
NO_INTERVENTION
label
Follow-up group
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.

Primary outcomes (1)

measure
progression-free survival

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

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.

References

Publications (17)

BACKGROUNDDavila RE, Faigel DO. GI stromal tumors. Gastrointest Endosc. 2003 Jul;58(1):80-8. doi: 10.1067/mge.2003.317. No abstract available. PMID 12838226
BACKGROUNDSiow 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. PMID 26922628
BACKGROUNDReichardt P. [Soft tissue sarcomas and gastrointestinal stromal tumors]. Internist (Berl). 2016 Mar;57(3):245-56. doi: 10.1007/s00108-016-0021-2. German. PMID 26907871
BACKGROUNDUcar 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. PMID 26897944
BACKGROUNDSornmayura P. Gastrointestinal stromal tumors (GISTs): a pathology view point. J Med Assoc Thai. 2009 Jan;92(1):124-35. PMID 19260254
BACKGROUNDESMO/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. PMID 25210085
BACKGROUNDMaghrebi 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. PMID 26895119
BACKGROUNDNovitsky 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.