Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor

• ClinicalTrials.gov Identifier: NCT04751591
• Recruitment Status: Not yet recruiting
• First Posted: February 12, 2021
• Last Update Posted: November 30, 2021
• Sponsor: Shanghai Zhongshan Hospital
• Information provided by (Responsible Party): Shanghai Zhongshan Hospital

Tracking Information

• First Submitted Date: January 30, 2021
• First Posted Date: February 12, 2021
• Last Update Posted Date: November 30, 2021
• Estimated Study Start Date: December 15, 2021
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 11, 2021)

• Early operative morbidity rate [ Time Frame: 30 days ]
  The early operative morbidity is defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications.
• Early operative mortality rate [ Time Frame: 30 days ]
  The early operative mortality is defined as deaths observed within 30 days following surgery.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 14, 2021)

• Operation time [ Time Frame: intraoperative ]
  Operation time is documented as a composite outcome measure.
• Time to first ambulation [ Time Frame: 30 days ]
  Time to first ambulation is used to assess the postoperative recovery course, which is a composite outcome measure.
• Time to first flatus [ Time Frame: 30 days ]
  Time to first flatus is used to assess the postoperative recovery course, which is a composite outcome measure.
• Time to first liquid diet [ Time Frame: 30 days ]
  Time to first liquid diet is used to assess the postoperative recovery course, which is a composite outcome measure.
• Time to first soft diet [ Time Frame: 30 days ]
  Time to first soft diet is used to assess the postoperative recovery course, which is a composite outcome measure.
• Postoperative hospital stay [ Time Frame: 30 days ]
  The length of postoperative hospital stay will be recorded.
• En bloc resection rate [ Time Frame: 0, day of endoscopic surgery or laparoscopic surgery ]
  The rate of en bloc resection in all cases will be recorded.

Original Secondary Outcome Measures (submitted: February 11, 2021)

• Operation time [ Time Frame: intraoperative ]
  Operation time is documented as a composite outcome measure.
• Time to first ambulation [ Time Frame: 30 days ]
  Time to first ambulation is used to assess the postoperative recovery course, which is a composite outcome measure.
• Time to first flatus [ Time Frame: 30 days ]
  Time to first flatus is used to assess the postoperative recovery course, which is a composite outcome measure.
• Time to first liquid diet [ Time Frame: 30 days ]
  Time to first liquid diet is used to assess the postoperative recovery course, which is a composite outcome measure.
• Time to first soft diet [ Time Frame: 30 days ]
  Time to first soft diet is used to assess the postoperative recovery course, which is a composite outcome measure.
• Postoperative hospital stay [ Time Frame: 30 days ]
  The length of postoperative hospital stay will be recorded.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor
• Official Title: Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Endoscopic Resection And Laparoscopic Partial Gastrectomy In Patients With 2-5cm Gastric Gastrointestinal Stromal Tumor
• Brief Summary: This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric gastrointestinal stromal tumor. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric gastrointestinal stromal tumor. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Detailed Description

Gastrointestinal stromal tumors (GIST) originate from interstitial cells of Cajal (ICC) and are the most common tumors derived from mesenchymal tissues of the digestive tract. GISTs can occur in any part of the digestive tract, among which gastric stromal tumors are the most common, accounting for about 60%. The incidence of GIST has been increasing in recent years, partly due to the gradual popularity of gastrointestinal endoscopy. Many early GISTs with smaller tumors have also received early diagnosis and treatment intervention. Due to the potential malignancy of GISTs, complete resection of the tumor is the first and only radical treatment option currently.

Many studies have shown that laparoscopy is safe and effective approach in the treatment of gastric stromal tumors. In principle, as long as the tumor can be completely resected (neither residue macro nor microscopic) with intact tumor capsule and without tumor rupture, laparoscopic surgery is definite an option. Studies showed both short-term and long-term results of laparoscopic surgery were comparable to conventional open surgeries.

On the other hand, endoscopic resection showed promising results in recent years. Endoscopic submucosal dissection endoscopic full-thickness resection are both reported with promising results in terms of safety and short-term efficacy.

Though endoscopic resection has been suggested as one of the treatment options for gastric GISTs, No randomized controlled trial for endoscopic resection versus laparoscopic partial gastrectomy exists at this moment. This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric GISTs. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric GISTs. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric GIST

Intervention

• Procedure: Endoscopic resection
  Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs
• Procedure: Laparoscopic partial gastrectomy
  Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs

Study Arms

• Experimental: Endoscopic resection
  The endoscopist will perform endoscopic resection for patients enrolled in this group.
  Intervention: Procedure: Endoscopic resection
• Laparoscopic partial gastrectomy
  The endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group.
  Intervention: Procedure: Laparoscopic partial gastrectomy

Publications *

• Kwon JG, Hwang SJ, Hennig GW, Bayguinov Y, McCann C, Chen H, Rossi F, Besmer P, Sanders KM, Ward SM. Changes in the structure and function of ICC networks in ICC hyperplasia and gastrointestinal stromal tumors. Gastroenterology. 2009 Feb;136(2):630-9. doi: 10.1053/j.gastro.2008.10.031. Epub 2008 Nov 1.
• Heinrich MC, Rubin BP, Longley BJ, Fletcher JA. Biology and genetic aspects of gastrointestinal stromal tumors: KIT activation and cytogenetic alterations. Hum Pathol. 2002 May;33(5):484-95. doi: 10.1053/hupa.2002.124124.
• Bamboat ZM, Dematteo RP. Updates on the management of gastrointestinal stromal tumors. Surg Oncol Clin N Am. 2012 Apr;21(2):301-16. doi: 10.1016/j.soc.2011.12.004.
• Steigen SE, Eide TJ. Trends in incidence and survival of mesenchymal neoplasm of the digestive tract within a defined population of northern Norway. APMIS. 2006 Mar;114(3):192-200. doi: 10.1111/j.1600-0463.2006.apm_261.x.
• 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.
• Pucci MJ, Berger AC, Lim PW, Chojnacki KA, Rosato EL, Palazzo F. Laparoscopic approaches to gastric gastrointestinal stromal tumors: an institutional review of 57 cases. Surg Endosc. 2012 Dec;26(12):3509-14. doi: 10.1007/s00464-012-2374-5. Epub 2012 Jun 9.
• Ohtani H, Maeda K, Noda E, Nagahara H, Shibutani M, Ohira M, Muguruma K, Tanaka H, Kubo N, Toyokawa T, Sakurai K, Yamashita Y, Yamamoto A, Hirakawa K. Meta-analysis of laparoscopic and open surgery for gastric gastrointestinal stromal tumor. Anticancer Res. 2013 Nov;33(11):5031-41.
• He Z, Sun C, Zheng Z, Yu Q, Wang T, Chen X, Cao H, Liu W, Wang B. Endoscopic submucosal dissection of large gastrointestinal stromal tumors in the esophagus and stomach. J Gastroenterol Hepatol. 2013 Feb;28(2):262-7. doi: 10.1111/jgh.12056.
• Zhou PH, Yao LQ, Qin XY, Cai MY, Xu MD, Zhong YS, Chen WF, Zhang YQ, Qin WZ, Hu JW, Liu JZ. Endoscopic full-thickness resection without laparoscopic assistance for gastric submucosal tumors originated from the muscularis propria. Surg Endosc. 2011 Sep;25(9):2926-31. doi: 10.1007/s00464-011-1644-y. Epub 2011 Mar 18.
• 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.
• 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.
• 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.
• Wang H, Feng X, Ye S, Wang J, Liang J, Mai S, Lai M, Feng H, Wang G, Zhou Y. A comparison of the efficacy and safety of endoscopic full-thickness resection and laparoscopic-assisted surgery for small gastrointestinal stromal tumors. Surg Endosc. 2016 Aug;30(8):3357-61. doi: 10.1007/s00464-015-4612-0. Epub 2015 Oct 23.
• Yin X, Yin Y, Chen H, Shen C, Tang S, Cai Z, Zhang B, Chen Z. Comparison Analysis of Three Different Types of Minimally Invasive Procedures for Gastrointestinal Stromal Tumors </=5 cm. J Laparoendosc Adv Surg Tech A. 2018 Jan;28(1):58-64. doi: 10.1089/lap.2017.0305. Epub 2017 Oct 30.
• Wu CR, Huang LY, Guo J, Zhang B, Cui J, Sun CM, Jiang LX, Wang ZH, Ju AH. Clinical Control Study of Endoscopic Full-thickness Resection and Laparoscopic Surgery in the Treatment of Gastric Tumors Arising from the Muscularis Propria. Chin Med J (Engl). 2015 Jun 5;128(11):1455-9. doi: 10.4103/0366-6999.157651.
• Huang LY, Cui J, Wu CR, Zhang B, Jiang LX, Xian XS, Lin SJ, Xu N, Cao XL, Wang ZH. Endoscopic full-thickness resection and laparoscopic surgery for treatment of gastric stromal tumors. World J Gastroenterol. 2014 Jul 7;20(25):8253-9. doi: 10.3748/wjg.v20.i25.8253.
• Chen L, Zhang Q, Li FY, Yang L, Zhang DC, Wang LJ, Wang WZ, Li Z, Xu JH, He ZY, Xu KJ, Chen M, Xu H, Xu ZK. Comparison of treatment outcomes between laparoscopic and endoscopic surgeries for relatively small gastric gastrointestinal stromal tumors. Surg Oncol. 2018 Dec;27(4):737-742. doi: 10.1016/j.suronc.2018.10.002. Epub 2018 Oct 2.
• Zhao Y, Pang T, Zhang B, Wang L, Lv Y, Ling T, Zhang X, Huang Q, Xu G, Zou X. Retrospective Comparison of Endoscopic Full-Thickness Versus Laparoscopic or Surgical Resection of Small (</= 5 cm) Gastric Gastrointestinal Stromal Tumors. J Gastrointest Surg. 2020 Dec;24(12):2714-2721. doi: 10.1007/s11605-019-04493-6. Epub 2019 Dec 10.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 14, 2021): 260
• Original Estimated Enrollment (submitted: February 11, 2021): 240
• Estimated Study Completion Date: June 30, 2024
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients diagnosed with gastric GISTs in imaging examinations including contrast-enhanced abdominal and pelvic CT, EGD examination and endoscopic ultrasound examination
• The maximum diameter of the tumor is > 2cm and ≤ 5cm
• No history of upper abdominal surgery (except for laparoscopic cholecystectomy)
• No history of neoadjuvant therapy or targeted therapy
• Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
• Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
• Sufficient organ functions
• Written informed consent

Exclusion Criteria:

• Gastric GISTs with completely extra-luminal growth pattern
• Metastases found in preopreative examinations
• History of simultaneous malignancies or heterochronous malignancies within 5 years
• Women during pregnancy or breast-feeding
• Severe heart and lung disease, severe renal insufficiency, unable to perform laparoscopic surgery
• Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
• Severe mental disease
• Severe respiratory disease
• Severe hepatic and renal dysfunction
• Unstable angina pectoris or history of myocardial infarction within 6 months
• History of cerebral infarction or cerebral hemorrhage within 6 months
• Patients with other diseases who can be surgically intervened at the same time
• Continuous systemic steroid therapy within 1 month (except for topical use)
• Patients are participating or have participated in another clinical trial (within 6 months)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tianyin Chen; +862164041990; chen_tianyin@126.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04751591
• Other Study ID Numbers: SK2020-032
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Shanghai Zhongshan Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Shanghai Zhongshan Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pinghong Zhou; Fudan University

• PRS Account: Shanghai Zhongshan Hospital
• Verification Date: November 2021