A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

• ClinicalTrials.gov Identifier: NCT05938309
• Recruitment Status: Recruiting
• First Posted: July 10, 2023
• Last Update Posted: July 10, 2023
• Sponsor: Fujian Medical University
• Collaborators: Fujian Provincial Hospital; Fujian Cancer Hospital; First Affiliated Hospital of Fujian Medical University; 900 th Hospital of Joint Logistics Support Force; The First Affiliated Hospital of Xiamen University; The Second Affiliated Hospital of Fujian Medical University; The First Hospital of Putian City; The Affiliated Hospital(Group) of Putian University; Zhangzhou Municipal Hospital of Fujian Province; Longyan City First Hospital
• Information provided by (Responsible Party): Chang-Ming Huang, Prof., Fujian Medical University

Study Description

Brief Summary:

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

Condition or disease
Gastrointestinal Stromal Tumors

Detailed Description:

There is a lack of high-quality evidence on the efficacy and safety of laparoscopic resection of gastric GIST over 5cm. A multicenter, prospective cohort study was conducted to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors (GIST) compared to laparoscopic resection of GIST of less than 5cm. The primary evaluation parameter is overall postoperative morbidity.

Study Design

• Study Type: Observational
• Estimated Enrollment: 194 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Multicenter Cohort Study on the Efficacy and Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
• Actual Study Start Date: May 1, 2023
• Estimated Primary Completion Date: May 1, 2025
• Estimated Study Completion Date: May 1, 2028

Groups and Cohorts

Group/Cohort
large group; laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors
small group; laparoscopic resection of less than 5cm gastric gastrointestinal stromal tumors

Outcome Measures

Primary Outcome Measures :

1. Overall postoperative morbidity [ Time Frame: 30 days after surgery or the first discharge ( if over 30 days hospital stay) ]
   This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.

Secondary Outcome Measures :

1. intraoperative morbidity rates [ Time Frame: 1 day ]
   The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
2. Conversion to open surgery rate [ Time Frame: 1 day ]
   Conversion to open surgery rate is defined as the rate of open surgery whatever the reason
3. Positive surgical margin rate [ Time Frame: 1 day ]
   Positive surgical margin rate
4. The variation of white blood cell count [ Time Frame: Preoperative 7 days and postoperative 1, 3, and 5 days ]
   The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
5. The variation of hemoglobin [ Time Frame: Preoperative 7 days and postoperative 1, 3, and 5 days ]
   The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
6. The variation of C-reactive protein [ Time Frame: Preoperative 7 days and postoperative 1, 3, and 5 days ]
   The values of C-reactive protein in milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response
7. overall postoperative serious morbidity rates [ Time Frame: 30 days after surgery or the first discharge ( if over 30 days hospital stay) ]
   According to the Clavien-Dindo complication scoring system, grade IIIA and above is a serious complication, and when multiple complications occur at the same time, the complication with the highest grade will prevail.
8. Time to first ambulation [ Time Frame: 30 days ]
   Time to first ambulation in days is used to assess the postoperative recovery course.
9. Time to first flatus [ Time Frame: 30 days ]
   Time to first flatus in days is used to assess the postoperative recovery course.
10. Time to first liquid diet [ Time Frame: 30 days ]
    Time to first liquid diet in days is used to assess the postoperative recovery course.
11. Time to first soft diet [ Time Frame: 30 days ]
    Time to first soft diet in days is used to assess the postoperative recovery course.
12. Duration of postoperative hospital stay [ Time Frame: 30 days ]
    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
13. 3-year overall survival rate [ Time Frame: 36 months ]
    3-year overall survival rate
14. 3-year disease free survival rate [ Time Frame: 36 months ]
    3-year disease free survival rate
15. 3-year recurrence pattern [ Time Frame: 36 months ]
    Recurrence patterns are classified into four categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, and mixed type

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

1. 18 years < age < 75 years
2. 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
3. Patient informed consent and willingness to undergo laparoscopic resection
4. Expected laparoscopic outcome of R0 resection
5. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Ping Li, MD，PhD; +8613365918502; Pingli811002@163.com

Contact: Linghua Wei; +8613512556021; weilinghua12345@163.com

Locations

China, Fujian

Department of Gastric Surgery， Fujian Medical University Union Hospital; Recruiting

Fuzhou, Fujian, China

Contact: Changming Huang, MD +8613805069676 hcmlr2002@163.com

Sponsors and Collaborators

Fujian Medical University

Fujian Provincial Hospital

Fujian Cancer Hospital

First Affiliated Hospital of Fujian Medical University

900 th Hospital of Joint Logistics Support Force

The First Affiliated Hospital of Xiamen University

The Second Affiliated Hospital of Fujian Medical University

The First Hospital of Putian City

The Affiliated Hospital(Group) of Putian University

Zhangzhou Municipal Hospital of Fujian Province

Longyan City First Hospital

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Chang-Ming Huang, Prof., Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor, Fujian Medical University
• ClinicalTrials.gov Identifier: NCT05938309
• Other Study ID Numbers: FUGES-029
• First Posted: July 10, 2023
• Last Update Posted: July 10, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Chang-Ming Huang, Prof., Fujian Medical University:

Gastrectomy; Laparoscopic; gastrointestinal stromal tumor

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases