NCT05938309

Brief Summary

The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
May 2023May 2028

Study Start

First participant enrolled

May 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Expected
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

June 19, 2023

Last Update Submit

July 3, 2023

Conditions

Gastrointestinal Stromal Tumors

Keywords

GastrectomyLaparoscopicgastrointestinal stromal tumor

Outcome Measures

Primary Outcomes (1)

  • Overall postoperative morbidity

    This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.

    30 days after surgery or the first discharge ( if over 30 days hospital stay)

Secondary Outcomes (15)

  • intraoperative morbidity rates

    1 day

  • Conversion to open surgery rate

    1 day

  • Positive surgical margin rate

    1 day

  • The variation of white blood cell count

    Preoperative 7 days and postoperative 1, 3, and 5 days

  • The variation of hemoglobin

    Preoperative 7 days and postoperative 1, 3, and 5 days

  • +10 more secondary outcomes

Study Arms (2)

large group

laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors

small group

laparoscopic resection of less than 5cm gastric gastrointestinal stromal tumors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are assigned to undergo gastrectomy for gastric gastrointestinal stromal tumors are included.

You may qualify if:

  • years \< age \< 75 years
  • Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or MR, and confirmed as primary gastric GIST by postoperative pathology
  • Patient informed consent and willingness to undergo laparoscopic resection
  • Expected laparoscopic outcome of R0 resection
  • Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III

You may not qualify if:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)
  • History of gastric surgery (except ESD/EMR for gastric cancer)
  • History of other malignant diseases within the past five years
  • History of unstable angina or myocardial infarction within the past six months
  • History of a cerebrovascular accident within the past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other diseases
  • Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastric Surgery， Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Related Publications (10)

  • Joensuu H, Hohenberger P, Corless CL. Gastrointestinal stromal tumour. Lancet. 2013 Sep 14;382(9896):973-83. doi: 10.1016/S0140-6736(13)60106-3. Epub 2013 Apr 24.

    PMID: 23623056BACKGROUND

  • Dematteo RP, Gold JS, Saran L, Gonen M, Liau KH, Maki RG, Singer S, Besmer P, Brennan MF, Antonescu CR. Tumor mitotic rate, size, and location independently predict recurrence after resection of primary gastrointestinal stromal tumor (GIST). Cancer. 2008 Feb 1;112(3):608-15. doi: 10.1002/cncr.23199.

    PMID: 18076015BACKGROUND

  • Bischof DA, Kim Y, Dodson R, Carolina Jimenez M, Behman R, Cocieru A, Blazer DG 3rd, Fisher SB, Squires MH 3rd, Kooby DA, Maithel SK, Groeschl RT, Clark Gamblin T, Bauer TW, Karanicolas PJ, Law C, Quereshy FA, Pawlik TM. Open versus minimally invasive resection of gastric GIST: a multi-institutional analysis of short- and long-term outcomes. Ann Surg Oncol. 2014 Sep;21(9):2941-8. doi: 10.1245/s10434-014-3733-3. Epub 2014 Apr 24.

    PMID: 24763984BACKGROUND

  • De Vogelaere K, Hoorens A, Haentjens P, Delvaux G. Laparoscopic versus open resection of gastrointestinal stromal tumors of the stomach. Surg Endosc. 2013 May;27(5):1546-54. doi: 10.1007/s00464-012-2622-8. Epub 2012 Dec 12.

    PMID: 23233005BACKGROUND

  • Goh BK, Goh YC, Eng AK, Chan WH, Chow PK, Chung YF, Ong HS, Wong WK. Outcome after laparoscopic versus open wedge resection for suspected gastric gastrointestinal stromal tumors: A matched-pair case-control study. Eur J Surg Oncol. 2015 Jul;41(7):905-10. doi: 10.1016/j.ejso.2015.04.001. Epub 2015 Apr 15.

    PMID: 25913060BACKGROUND

  • von Mehren M, Randall RL, Benjamin RS, Boles S, Bui MM, Casper ES, Conrad EU 3rd, DeLaney TF, Ganjoo KN, George S, Gonzalez RJ, Heslin MJ, Kane JM 3rd, Mayerson J, McGarry SV, Meyer C, O'Donnell RJ, Pappo AS, Paz IB, Pfeifer JD, Riedel RF, Schuetze S, Schupak KD, Schwartz HS, Van Tine BA, Wayne JD, Bergman MA, Sundar H. Gastrointestinal stromal tumors, version 2.2014. J Natl Compr Canc Netw. 2014 Jun;12(6):853-62. doi: 10.6004/jnccn.2014.0080.

    PMID: 24925196BACKGROUND

  • Goh BK, Chow PK, Chok AY, Chan WH, Chung YF, Ong HS, Wong WK. Impact of the introduction of laparoscopic wedge resection as a surgical option for suspected small/medium-sized gastrointestinal stromal tumors of the stomach on perioperative and oncologic outcomes. World J Surg. 2010 Aug;34(8):1847-52. doi: 10.1007/s00268-010-0590-5.

    PMID: 20407770BACKGROUND

  • Piessen G, Lefevre JH, Cabau M, Duhamel A, Behal H, Perniceni T, Mabrut JY, Regimbeau JM, Bonvalot S, Tiberio GA, Mathonnet M, Regenet N, Guillaud A, Glehen O, Mariani P, Denost Q, Maggiori L, Benhaim L, Manceau G, Mutter D, Bail JP, Meunier B, Porcheron J, Mariette C, Brigand C; AFC and the FREGAT working group. Laparoscopic Versus Open Surgery for Gastric Gastrointestinal Stromal Tumors: What Is the Impact on Postoperative Outcome and Oncologic Results? Ann Surg. 2015 Nov;262(5):831-9; discussion 829-40. doi: 10.1097/SLA.0000000000001488.

    PMID: 26583673BACKGROUND

  • Khoo CY, Goh BKP, Eng AKH, Chan WH, Teo MCC, Chung AYF, Ong HS, Wong WK. Laparoscopic wedge resection for suspected large (>/=5 cm) gastric gastrointestinal stromal tumors. Surg Endosc. 2017 May;31(5):2271-2279. doi: 10.1007/s00464-016-5229-7. Epub 2016 Sep 8.

    PMID: 27631317BACKGROUND

  • 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: 35145127BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

Ping Li, MD，PhD

CONTACT

+8613365918502Pingli811002@163.com

Linghua Wei

CONTACT

+8613512556021weilinghua12345@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

June 19, 2023

First Posted

July 10, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2025

Study Completion (Estimated)

May 1, 2028

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)