Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:39 AM
Study NCT ID:
NCT07411118
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT of EFTR Versus STER for GIST Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2033-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete R0 resection', 'timeFrame': '1 day', 'description': 'Complete R0 resection, defined as en-bloc complete endoscopic resection with intact tumor capsule and histological negative resection margins.\n\nMeasure unit: % of lesions.'}], 'secondaryOutcomes': [{'measure': 'Rate of Intra-procedural adverse events', 'timeFrame': '1 day', 'description': 'Intra-procedural adverse events (AE), including specific AE such as haemorrhage, tension capnoperitoneum, injury to adjacent peritoneal organs, unintentional mucosal injury / perforation, failed tumor retrieval, and general AE such as cardiovascular, pulmonary or other anaesthetic related events. All adverse events would be documented and graded based on the Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 and ASGE endoscopic adverse event Lexicon.\n\nMeasure unit: % of procedure.'}, {'measure': 'Rate of post-procedural adverse events', 'timeFrame': '30 days', 'description': 'Post-procedural adverse events within 30 days, including specific AE such as delayed haemorrhage, peritonitis, intra-abdominal abscess / collection, and general AE such as cardiovascular, pulmonary or other anaesthetic related events. All adverse events would be documented and graded based on the Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 and ASGE endoscopic adverse event Lexicon.\n\nMeasure unit: % of procedure.'}, {'measure': 'Procedure time', 'timeFrame': '1 day', 'description': 'Defined from beginning of mucosal incision until complete closure of the defect (full thickness defect or tunnel opening) after tumor resection.\n\nMeasure unit: Minutes.'}, {'measure': 'Crossover rate to EFTR in STER group', 'timeFrame': '30 days', 'description': 'Crossover rate to EFTR due to failure in STER group., defined as proportion of STER-assigned cases requiring crossover to EFTR (%).\n\nMeasure unit: % of patients.'}, {'measure': 'Conversion rate to major surgery', 'timeFrame': '30 days', 'description': 'Rate of conversion to major surgery as salvage for failure or adverse event, defined as proportion of cases requiring conversion to major surgery (%).\n\nMeasure unit: % of patients.'}, {'measure': 'Recurrence rate', 'timeFrame': '30 days', 'description': 'Recurrence rate on surveillance endoscopy and Computed Tomography. defined as proportion of patients with local or distant tumor recurrence (%).\n\nMeasure unit: % of patients.'}, {'measure': 'Patient-reported VAS scores', 'timeFrame': 'Day 1, 3, 7, and 14 after procedure', 'description': 'Patient reported outcomes on post-procedural pain at Day 1, 3, 7, 14 after procedure, using Visual Analogue Scale (VAS) (range: 1-10), where higher score means higher level of pain.\n\nMeasure unit: VAS score (0-10)'}, {'measure': 'Endoscopist-rated procedural difficulty', 'timeFrame': '1 day', 'description': 'Endoscopist rating of procedural difficulty, according to Likert scale of 1-5, where higher score indicates more perceived difficulty.\n\nMeasure unit: Likert score 1-5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EFTR', 'STER', 'GIST'], 'conditions': ['Small Size Gastrointestinal Stromal Tumors', 'GIST']}, 'referencesModule': {'references': [{'pmid': '20189503', 'type': 'BACKGROUND', 'citation': 'Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.'}, {'pmid': '36845271', 'type': 'BACKGROUND', 'citation': 'Chiu PWY, Yip HC, Chan SM, Ng SKK, Teoh AYB, Ng EKW. Endoscopic full-thickness resection (EFTR) compared to submucosal tunnel endoscopic resection (STER) for treatment of gastric gastrointestinal stromal tumors. Endosc Int Open. 2023 Feb 23;11(2):E179-E186. doi: 10.1055/a-1972-3409. eCollection 2023 Feb.'}, {'pmid': '41646066', 'type': 'BACKGROUND', 'citation': 'Tun KM, Dhindsa BS, Dossaji Z, Deliwala SS, Narra G, Haque L, Lo CH, Dhaliwal A, Chandan S, Ramai D, Singh S, Adler DG. Efficacy and safety of submucosal tunneling endoscopic resection for subepithelial tumors in the upper GI tract: a systematic review and meta-analysis of >2900 patients. IGIE. 2023 Aug 19;2(4):529-537.e2. doi: 10.1016/j.igie.2023.08.005. eCollection 2023 Dec.'}, {'pmid': '34654680', 'type': 'BACKGROUND', 'citation': 'Granata A, Martino A, Ligresti D, Tuzzolino F, Lombardi G, Traina M. Exposed endoscopic full-thickness resection without laparoscopic assistance for gastric submucosal tumors: A systematic review and pooled analysis. Dig Liver Dis. 2022 Jun;54(6):729-736. doi: 10.1016/j.dld.2021.09.014. Epub 2021 Oct 13.'}, {'pmid': '31388606', 'type': 'BACKGROUND', 'citation': 'ASGE Technology Committee; Aslanian HR, Sethi A, Bhutani MS, Goodman AJ, Krishnan K, Lichtenstein DR, Melson J, Navaneethan U, Pannala R, Parsi MA, Schulman AR, Sullivan SA, Thosani N, Trikudanathan G, Trindade AJ, Watson RR, Maple JT. ASGE guideline for endoscopic full-thickness resection and submucosal tunnel endoscopic resection. VideoGIE. 2019 Jun 29;4(8):343-350. doi: 10.1016/j.vgie.2019.03.010. eCollection 2019 Aug.'}, {'pmid': '34695421', 'type': 'BACKGROUND', 'citation': 'Mahmoud T, Wong Kee Song LM, Stavropoulos SN, Alansari TH, Ramberan H, Fukami N, Marya NB, Rau P, Marshall C, Ghandour B, Bejjani M, Khashab MA, Haber GB, Aihara H, Antillon-Galdamez MR, Chandrasekhara V, Abu Dayyeh BK, Storm AC. Initial multicenter experience using a novel endoscopic tack and suture system for challenging GI defect closure and stent fixation (with video). Gastrointest Endosc. 2022 Feb;95(2):373-382. doi: 10.1016/j.gie.2021.10.018. Epub 2021 Oct 22.'}, {'pmid': '37076983', 'type': 'BACKGROUND', 'citation': 'Tani Y, Uedo N, Nomura T. Reopenable-clip over-the-line method for closure of gastric endoscopic full-thickness resection defect. Dig Endosc. 2023 Jul;35(5):e85-e86. doi: 10.1111/den.14562. Epub 2023 Apr 19. No abstract available.'}, {'pmid': '24442680', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Wang X, Xiong G, Qian Y, Wang H, Liu L, Miao L, Fan Z. Complete defect closure of gastric submucosal tumors with purse-string sutures. Surg Endosc. 2014 Jun;28(6):1844-51. doi: 10.1007/s00464-013-3404-7. Epub 2014 Jan 18.'}, {'pmid': '25701060', 'type': 'BACKGROUND', 'citation': 'Guo J, Liu Z, Sun S, Liu X, Wang S, Ge N, Wang G, Qi Y. Endoscopic full-thickness resection with defect closure using an over-the-scope clip for gastric subepithelial tumors originating from the muscularis propria. Surg Endosc. 2015 Nov;29(11):3356-62. doi: 10.1007/s00464-015-4076-2. Epub 2015 Feb 21.'}, {'pmid': '27569858', 'type': 'BACKGROUND', 'citation': 'Al-Bawardy B, Rajan E, Wong Kee Song LM. Over-the-scope clip-assisted endoscopic full-thickness resection of epithelial and subepithelial GI lesions. Gastrointest Endosc. 2017 May;85(5):1087-1092. doi: 10.1016/j.gie.2016.08.019. Epub 2016 Aug 26.'}, {'pmid': '30604266', 'type': 'BACKGROUND', 'citation': 'Chiu PWY, Yip HC, Teoh AYB, Wong VWY, Chan SM, Wong SKH, Ng EKW. Per oral endoscopic tumor (POET) resection for treatment of upper gastrointestinal subepithelial tumors. Surg Endosc. 2019 Apr;33(4):1326-1333. doi: 10.1007/s00464-018-06627-4. Epub 2019 Jan 2.'}, {'pmid': '24013472', 'type': 'BACKGROUND', 'citation': 'Ye LP, Zhang Y, Mao XL, Zhu LH, Zhou X, Chen JY. Submucosal tunneling endoscopic resection for small upper gastrointestinal subepithelial tumors originating from the muscularis propria layer. Surg Endosc. 2014 Feb;28(2):524-30. doi: 10.1007/s00464-013-3197-8. Epub 2013 Sep 7.'}, {'pmid': '28059965', 'type': 'BACKGROUND', 'citation': 'Chen T, Zhou PH, Chu Y, Zhang YQ, Chen WF, Ji Y, Yao LQ, Xu MD. Long-term Outcomes of Submucosal Tunneling Endoscopic Resection for Upper Gastrointestinal Submucosal Tumors. Ann Surg. 2017 Feb;265(2):363-369. doi: 10.1097/SLA.0000000000001650.'}, {'pmid': '26517846', 'type': 'BACKGROUND', 'citation': 'Chen T, Zhang C, Yao LQ, Zhou PH, Zhong YS, Zhang YQ, Chen WF, Li QL, Cai MY, Chu Y, Xu MD. Management of the complications of submucosal tunneling endoscopic resection for upper gastrointestinal submucosal tumors. Endoscopy. 2016 Feb;48(2):149-55. doi: 10.1055/s-0034-1393244. Epub 2015 Oct 30.'}, {'pmid': '22056087', 'type': 'BACKGROUND', 'citation': 'Xu MD, Cai MY, Zhou PH, Qin XY, Zhong YS, Chen WF, Hu JW, Zhang YQ, Ma LL, Qin WZ, Yao LQ. Submucosal tunneling endoscopic resection: a new technique for treating upper GI submucosal tumors originating from the muscularis propria layer (with videos). Gastrointest Endosc. 2012 Jan;75(1):195-9. doi: 10.1016/j.gie.2011.08.018. Epub 2011 Nov 5. No abstract available.'}, {'pmid': '35180797', 'type': 'BACKGROUND', 'citation': "Deprez PH, Moons LMG, O'Toole D, Gincul R, Seicean A, Pimentel-Nunes P, Fernandez-Esparrach G, Polkowski M, Vieth M, Borbath I, Moreels TG, Nieveen van Dijkum E, Blay JY, van Hooft JE. Endoscopic management of subepithelial lesions including neuroendocrine neoplasms: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Apr;54(4):412-429. doi: 10.1055/a-1751-5742. Epub 2022 Feb 18."}, {'pmid': '34560242', 'type': 'BACKGROUND', 'citation': 'Casali PG, Blay JY, Abecassis N, Bajpai J, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Boye K, Brodowicz T, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dufresne A, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Frezza AM, Gasperoni S, Gelderblom H, Gouin F, Grignani G, Haas R, Hassan AB, Hindi N, Hohenberger P, Joensuu H, Jones RL, Jungels C, Jutte P, Kasper B, Kawai A, Kopeckova K, Krakorova DA, Le Cesne A, Le Grange F, Legius E, Leithner A, Lopez-Pousa A, Martin-Broto J, Merimsky O, Messiou C, Miah AB, Mir O, Montemurro M, Morosi C, Palmerini E, Pantaleo MA, Piana R, Piperno-Neumann S, Reichardt P, Rutkowski P, Safwat AA, Sangalli C, Sbaraglia M, Scheipl S, Schoffski P, Sleijfer S, Strauss D, Strauss SJ, Hall KS, Trama A, Unk M, van de Sande MAJ, van der Graaf WTA, van Houdt WJ, Frebourg T, Gronchi A, Stacchiotti S; ESMO Guidelines Committee, EURACAN and GENTURIS. Electronic address: clinicalguidelines@esmo.org. Gastrointestinal stromal tumours: ESMO-EURACAN-GENTURIS Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2022 Jan;33(1):20-33. doi: 10.1016/j.annonc.2021.09.005. Epub 2021 Sep 21. No abstract available.'}, {'pmid': '31864827', 'type': 'BACKGROUND', 'citation': 'Wang C, Gao Z, Shen K, Cao J, Shen Z, Jiang K, Wang S, Ye Y. Safety and efficiency of endoscopic resection versus laparoscopic resection in gastric gastrointestinal stromal tumours: A systematic review and meta-analysis. Eur J Surg Oncol. 2020 Apr;46(4 Pt A):667-674. doi: 10.1016/j.ejso.2019.10.030. Epub 2019 Dec 13.'}, {'pmid': '31317459', 'type': 'BACKGROUND', 'citation': 'Xiong Z, Wan W, Zeng X, Liu W, Wang T, Zhang R, Li C, Yang W, Zhang P, Tao K. Laparoscopic Versus Open Surgery for Gastric Gastrointestinal Stromal Tumors: a Propensity Score Matching Analysis. J Gastrointest Surg. 2020 Aug;24(8):1785-1794. doi: 10.1007/s11605-019-04318-6. Epub 2019 Jul 16.'}, {'pmid': '35145127', 'type': 'BACKGROUND', 'citation': 'Park SH, Lee HJ, Kim MC, Yook JH, Sohn TS, Hyung WJ, Ryu SW, Kurokawa Y, Kim YW, Han SU, Kim HH, Park DJ, Kim W, Lee SI, Cho H, Cho GS, Kim JJ, Kim KH, Yoo MW, Yang HK. Early experience of laparoscopic resection and comparison with open surgery for gastric gastrointestinal stromal tumor: a multicenter retrospective study. Sci Rep. 2022 Feb 10;12(1):2290. doi: 10.1038/s41598-022-05044-x.'}, {'pmid': '27384163', 'type': 'BACKGROUND', 'citation': 'Koo DH, Ryu MH, Kim KM, Yang HK, Sawaki A, Hirota S, Zheng J, Zhang B, Tzen CY, Yeh CN, Nishida T, Shen L, Chen LT, Kang YK. Asian Consensus Guidelines for the Diagnosis and Management of Gastrointestinal Stromal Tumor. Cancer Res Treat. 2016 Oct;48(4):1155-1166. doi: 10.4143/crt.2016.187. Epub 2016 Jun 24.'}, {'pmid': '17197927', 'type': 'BACKGROUND', 'citation': 'Agaimy A, Wunsch PH, Hofstaedter F, Blaszyk H, Rummele P, Gaumann A, Dietmaier W, Hartmann A. Minute gastric sclerosing stromal tumors (GIST tumorlets) are common in adults and frequently show c-KIT mutations. Am J Surg Pathol. 2007 Jan;31(1):113-20. doi: 10.1097/01.pas.0000213307.05811.f0.'}, {'pmid': '26618334', 'type': 'BACKGROUND', 'citation': 'Soreide K, Sandvik OM, Soreide JA, Giljaca V, Jureckova A, Bulusu VR. Global epidemiology of gastrointestinal stromal tumours (GIST): A systematic review of population-based cohort studies. Cancer Epidemiol. 2016 Feb;40:39-46. doi: 10.1016/j.canep.2015.10.031. Epub 2015 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic resection has been increasing utilized as the treatment for small size gastrointestinal stromal tumors (GIST), of which the best resection method has not been identified. We aim to compare the outcomes of endoscopic full thickness resection (EFTR) versus submucosal tunnelling endoscopic resection (STER) for clinical small gastric GIST. We hypothesize that EFTR could achieve better complete margin negative resection than STER without increase in adverse event.\n\nThis is an international multi-center double blinded randomized controlled trial involving four high volume centers from Hong Kong, mainland China, India and Japan. Adult patients with clinical 1.0-3.Scm gastric GIST undergoing endoscopic resection would be recruited.\n\nPatients would be randomized to undergo EFTR (intervention) or STER (Control) by expert endoscopists under general anaesthesia according to well published methods.', 'detailedDescription': 'Gastrointestinal stromal tumor (GIST) is the most common mesenchymal tumors in the GI tract, often located in the stomach. Based on the latest World Health Organization (WHO) classification, all GISTs are now considered as malignant tumors. Large size overtly aggressive GISTs are relatively rare, occurring only in up to 8 per million population. However, smaller sizes GIST in the stomach are relatively common, and was found in up to 20% of patients based on autopsy series.\n\nConventionally, localized GISTs are treated by surgical resection. Several guidelines recommended resection of all histologically confirmed GIST, while some suggested surveillance if the lesion is small \\<2cm in size. The principle of surgery for GIST is for en-bloc margin negative complete resection, while lymph node dissection is not required. As such, laparoscopic resection of gastric GIST has been advocated when technically feasible, demonstrating short term benefits in recovery than open surgery, with similar oncological outcomes.\n\nWith the technological advances of endoscopic surgery including endoscopic submucosal dissection (ESD) for early epithelial cancers and per-oral endoscopic myotomy (POEM), there was a rapid expansion in the indication of endoscopic surgery, in particular resection of subepithelial tumors (SET) in the gastrointestinal tract, in which a significant proportion are GISTs. Systematic review revealed a shorter procedure time and improved short-term recovery by endoscopic resection versus laparoscopic resection, without significant difference in complication and survival. With the favourable outcomes consistently reported in the literature regarding endoscopic resection of upper gastrointestinal GISTs, several endoscopy and oncology society guidelines are now recommending endoscopic resection as an option for smaller size GISTs in institutions with expertise on therapeutic endoscopy.\n\nSubmucosal tunneling endoscopic resection (STER) was first reported by Xu, et al in 2012. The concept of the procedure is to create a submucosal tunnel away from the tumor that arose from the musclaris propria layer while protecting the mucosa directly overlying the lesion, so that only mucosal closure of the tunnel entrance would be required after resection. The technique was first used on esophageal SET, where majority of them are benign leiomyoma. STER was then subsequently applied to other upper gastrointestinal tract lesions including the stomach. The merit of the technique mainly lies in the simplicity of closure of the mucosal incision, which only requires simple through-the-scope (TTS) clips. A schematic diagram of the STER procedure is shown in Figure 1.\n\nDevelopment of various techniques that allowed secure endoscopic water-tight closure of full thickness wall defect has led to increasing application of endoscopic full thickness resection (EFTR). As opposed to the STER procedure, the tumor would be directly resected without creation of a submucosal tunnel. This would create a full thickness defect that required complete closure to avoid gastrointestinal leakage and peritonitis. Various methods have been reported for closure, ranging from simple TTS clip closure, over-the-scope clip closure, clip endo-loop purse string technique, re-openable clip over-the-line method (ROLM), endoscopic suturing etc. With appropriate selection of closure method based on the morphology of the defect, secure closure could be achieved with minimal post-procedural morbidity.\n\nAmerican Society of Gastrointestinal Endoscopy (ASGE) has recently published a guideline on endoscopic full thickness resection, where STER procedure would be classified as exposed tunneled type EFTR. The EFTR procedure mentioned in previous paragraph would be classified as exposed non-tunneled type EFTR. Due to the complexity of the nomenclature, EFTR and STER will be used in the subsequent text for easier understanding of the technique described.\n\nBoth EFTR and STER has been increasingly utilized in resecting gastric subepithelial tumors including GISTs. In a recent systematic review of 952 gastric EFTR procedures including 523 GISTs, en-bloc margin negative resection was achieved in 99.3%, with surgical conversion rate of 0.09%. Pooled estimate of major adverse event was only 0.29%. On the other hand, systematic review of 2941 STER procedure reported margin negative resection rate of 92.4% with major adverse event of 1.2%. Of note, when only gastric lesion or lesion arising from muscularis propria layer were considered, the margin negative resection rate dropped to 90.6% and 88.3% respectively. While both procedures remained safe and feasible, margin negative resection appeared to be better achieved with EFTR. In the aforementioned studies, recurrence was observed on 0% and 2.3% of patients after EFTR and STER respectively.\n\nThe investigators have recently reported a retrospective analysis comparing EFTR and STER for gastric GISTs. In line with the current literature, complete margin negative resection was achieved in a significantly higher proportion with EFTR than STER (100% versus 80%, p=0.029), while no difference was found in the incidence of post-procedural adverse event. It is believed that EFTR is superior to STER in obtaining clear surgical margin, as dissection within the submucosal tunnel is challenging in achieving a wide margin without breaching tumor capsule, especially when tumor size is larger than 2cm. The concern for inadequate defect closure has also recently been overcome by numerous new developments of full thickness closure methods as described above. In the study, local recurrence was observed in 1 patient after STER, while no recurrence was found in the EFTR group. The event rate of recurrence was both low for both STER and EFTR, thus statistically significant difference could not be detected without a huge sample size. Nonetheless, it is however anticipated that with better margin negative resection, EFTR could achieve a lower recurrence rate for malignant GIST than STER, and margin negative complete resection should be a reasonable surrogate outcome for oncological clearance.\n\nTo date there has not been any prospective comparative study comparing EFTR and STER for small size gastric GISTs. The investigators have therefore designed the current international prospective randomized controlled trial aiming to demonstrate the superiority of EFTR in achieving better margin negative resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Consecutive adult patients age \\>=18 and \\<=75 with a clinical diagnosis of gastric GIST who opted for endoscopic resection would be screened for eligibility.\n\nInclusion Criteria:\n\n* Presence of gastric subepithelial tumor on diagnostic upper endoscopy, and\n* Diagnostic EUS and CT scan with intravenous contrast suspicious of GIST arising from muscularis propria layer, size with maximum diameter \\>=1.0cm and \\<= 3.5cm, and\n* Absence of high risk features, including irregular margins, invasion to surrounding organs, lesion hypervascularity, and\n* Endoscopic morphology and location deemed feasible with both EFTR and STER by an expert endoscopist, or\n* Histological confirmation of GIST through EUS guided fine needle biopsy (Optional, based on recommendation from guidelines)\n\nExclusion Criteria:\n\n* Patients with tumors deemed not suitable for endoscopic resection (Either EFTR or STER), due to unfavourable location, high risk morphology, or any other reasons.\n* Patients with multiple tumors.\n* Patients unable or unwilling to provide consent.\n* Previous esophageal or gastric surgery.\n* Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above.\n* Pregnant women or those planning pregnancy or breastfeeding women.\n* Uncorrectable coagulopathy defined by international normalized ratio (INR) \\> 1.5 or platelet count \\< 50000/µl.\n* Patients on double anti-platelet agents or anti-coagulation (Warfarin, heparin or other direct oral anticoagulants)'}, 'identificationModule': {'nctId': 'NCT07411118', 'briefTitle': 'RCT of EFTR Versus STER for GIST Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Exposed Endoscopic Full Thickness Resection (EFTR) Versus Submucosal Tunnelling Endoscopic Resection (STER) for Small Gastric Gastrointestinal Stromal Tumor (GIST) - an International Double Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CRE-2024.509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoscopic full thickness resection (EFTR) Group', 'description': 'Patients would be randomized to undergo EFTR by expert endoscopists under general anaesthesia according to well published methods.', 'interventionNames': ['Procedure: Endoscopic full thickness resection (EFTR) / Exposed non-tunneling EFTR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Submucosal Tunneling Endoscopic Resection (STER) Group', 'description': 'Patients would be randomized to undergo STER by expert endoscopists under general anaesthesia according to well published methods.', 'interventionNames': ['Procedure: Submucosal Tunneling Endoscopic Resection (STER) / Exposed tunneling EFTR']}], 'interventions': [{'name': 'Endoscopic full thickness resection (EFTR) / Exposed non-tunneling EFTR', 'type': 'PROCEDURE', 'description': "The procedure would be performed in similar way as reported in the literature. A therapeutic endoscope would be used and the target lesion identified. After submucosal injection of solution around the lesion, mucosal incision would be performed with dedicated dissection knife, followed by submucosal dissection. After adequate submucosal dissection to expose the muscularis propria layer around the tumor, the muscle layer would be dissected to achieve full thickness resection. Care would be taken to avoid breaching of the tumor capsule during the procedure and to aim for en-bloc tumor resection. During the procedure, countertraction technique could be utilized according to the discretion of the endoscopists. Clip or snare related traction methods such as clip-line traction are allowed depending on the endoscopists' preference. In case of development of significant pneumoperitoneum, decompression could be performed by transcutaneous needle.", 'armGroupLabels': ['Endoscopic full thickness resection (EFTR) Group']}, {'name': 'Submucosal Tunneling Endoscopic Resection (STER) / Exposed tunneling EFTR', 'type': 'PROCEDURE', 'description': 'As with exposed EFTR, the STER procedure would also be performed in similar way as reported in literature. After identification of the tumor location, a mucosal incision would be made at 3-4cm proximal to it after submucosal injection of saline mixture. Submucosal tunnel would then be created until identification of the tumor within the tunnel. Circumferential dissection would then be performed around the tumor until complete resection is achieved. During the procedure, the dissection plane would aim to avoid breaching tumor capsule in similar manner with EFTR group. The resected specimen would then be retrieved through the tunnel opening. After confirming adequate haemostasis within the submucosal tunnel, the mucosal incision would be closed with TTS clips. In case of failure of STER, cross-over to EFTR would be allowed in order to achieve tumor resection.', 'armGroupLabels': ['Submucosal Tunneling Endoscopic Resection (STER) Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Department of Gastroenterology, Zhongshan Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Hon Chi Yip, MBChB, FRCSEd (General)', 'role': 'CONTACT', 'email': 'hcyip@surgery.cuhk.edu.hk', 'phone': '+852 3505 2956'}], 'facility': 'Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hyderabad', 'status': 'NOT_YET_RECRUITING', 'country': 'India', 'contacts': [{'name': 'Mohan Ramchandani', 'role': 'CONTACT', 'email': 'ramchandanimohan@gmail.com'}], 'facility': 'Asian Institute of Gastroenterology', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Osaka', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Noriya Uedo', 'role': 'CONTACT', 'email': 'uedou-no@mc.pref.osaka.jp'}], 'facility': 'Osaka International Cancer Institute', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'centralContacts': [{'name': 'Hon Chi Yip', 'role': 'CONTACT', 'email': 'hcyip@surgery.cuhk.edu.hk', 'phone': '+852 3505 2956'}], 'overallOfficials': [{'name': 'Hon Chi Yip', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Osaka International Cancer Institute', 'class': 'UNKNOWN'}, {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hon Chi Yip', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}