Gastric GISTNCT04751591
Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor
A study testing Endoscopic resection and Laparoscopic partial gastrectomy in people with Gastric GIST, run by Shanghai Zhongshan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric GIST
- What is being tested?
- Endoscopic resection and Laparoscopic partial gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Gastric GIST
- Being tested
- Endoscopic resection, Laparoscopic partial gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic resectionProcedure or surgery
Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs
Laparoscopic partial gastrectomyProcedure or surgery
Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic resection | Experimental | The endoscopist will perform endoscopic resection for patients enrolled in this group. Receives: Procedure: Endoscopic resection |
| Laparoscopic partial gastrectomy | Other | The endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group. Receives: Procedure: Laparoscopic partial gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early operative morbidity rate
The early operative morbidity is defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications.
Measured: 30 days
Early operative mortality rate
The early operative mortality is defined as deaths observed within 30 days following surgery.
Measured: 30 days
Secondary outcomes (7)
Operation time
Operation time is documented as a composite outcome measure.
Measured: intraoperative
Time to first ambulation
Time to first ambulation is used to assess the postoperative recovery course, which is a composite outcome measure.
Measured: 30 days
Time to first flatus
Time to first flatus is used to assess the postoperative recovery course, which is a composite outcome measure.
Measured: 30 days
Time to first liquid diet
Time to first liquid diet is used to assess the postoperative recovery course, which is a composite outcome measure.
Measured: 30 days
Time to first soft diet
Time to first soft diet is used to assess the postoperative recovery course, which is a composite outcome measure.
Measured: 30 days
Postoperative hospital stay
The length of postoperative hospital stay will be recorded.
Measured: 30 days
En bloc resection rate
The rate of en bloc resection in all cases will be recorded.
Measured: 0, day of endoscopic surgery or laparoscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start15 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Gastric GISTStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pinghong Zhou, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751591
- Sponsor's protocol ID
- SK2020-032
- Status last verified
- Nov 2021
- First submitted
- 30 Jan 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19032955Heinrich 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.
PubMed 12094373Bamboat 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.
PubMed 22365521Steigen 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.
PubMed 16643186Demetri 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.
PubMed 20457867Pucci 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.
PubMed 22684977Ohtani 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.
PubMed 24222147He 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.
PubMed 23190047Zhou 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.
PubMed 21424195Chen 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.
PubMed 28059965ASGE 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.
PubMed 31388606Wang 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.
PubMed 31864827Wang 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.
PubMed 26497947Yin 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.
PubMed 29083255Wu 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.
PubMed 26021500
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04751591
- Acronym / sponsor ID
- SK2020-032
- Conditions
- Gastric GIST
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic resection | Experimental | Procedure: Endoscopic resectionThe endoscopist will perform endoscopic resection for patients enrolled in this group. |
| Laparoscopic partial gastrectomy | Other | Procedure: Laparoscopic partial gastrectomyThe endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic resectionEndoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs | Procedure or surgery | Endoscopic resection |
| Laparoscopic partial gastrectomyLaparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs | Procedure or surgery | Laparoscopic partial gastrectomy |
Primary outcome
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.
7 secondary outcomes
Operation time
Time frame: intraoperative
Time to first ambulation
Time frame: 30 days
Time to first flatus
Time frame: 30 days
Time to first liquid diet
Time frame: 30 days
Time to first soft diet
Time frame: 30 days
Postoperative hospital stay
Time frame: 30 days
En bloc resection rate
Time frame: 0, day of endoscopic surgery or laparoscopic surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Background: PubMed 19032955Kwon 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.
- Background: PubMed 12094373Heinrich 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.
- Background: PubMed 22365521Bamboat 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.
- Background: PubMed 16643186Steigen 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.
- Background: PubMed 20457867Demetri 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.
- Background: PubMed 22684977Pucci 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.
- Background: PubMed 24222147Ohtani 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.
- Background: PubMed 23190047He 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.
- Background: PubMed 21424195Zhou 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.
- Background: PubMed 28059965Chen 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.
- Background: PubMed 31388606ASGE 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.
- Background: PubMed 31864827Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinghong Zhou principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic resection and Laparoscopic partial gastrectomy in people with Gastric GIST, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianyin Chen (+862164041990, chen_tianyin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early operative morbidity rate (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751591, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.