Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04652986
Other study ID # HMCampo
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2004
Est. completion date December 2022

Study information

Verified date November 2020
Source Hospital Medina del Campo
Contact Juan Carlos Martín del Olmo, MD,PhD
Phone +34 629646199
Email jcmolmo@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective study of the results of laparoscopic approach of gastric carcinoma in western patients is designed. The working hypothesis proposes obtaining similar results to those obtained in the series reported by eastern hospitals (Japan and Korea) and, at least, equivalent to those recorded in conventional surgery.


Description:

This is a single-center prospective study. All gastric adenocarcinoma patients operated on between January 2004 and December 2022 who underwent laparoscopic resection with D1-D2 lymphadenectomy were considered. The exclusion criteria were patients who were lost to follow-up, were unfit for surgery, underwent palliative surgery or had T4b lesions or gastric neoplasms other than adenocarcinoma. The preoperative evaluation included laboratory tests, upper digestive endoscopy with biopsy, computed tomography scans (chest, abdomen, and pelvis), and endoscopic ultrasound in selected cases. The tumor node, metastasis (TNM) protocol of the College of American Pathologists was used for staging In the preoperative workup, the patients were classified according to the American Anesthesiology Association (ASA). Perioperative and postoperative complications will be classified according to the Clavien-Dindo system. Length of hospital stay, age, sex, comorbidities, extent of surgery, pTNM stage, and disease-free survival (DFS) will be analyzed. The followed-up it is planned at one, three and six months after surgery and every 6 months later until the fifth year, then once a year. Statistical analyses were performed using SPSS, ver. 25.0 (SPSS Inc., Chicago IL, USA). The demographics, perioperative data, operation details, length of hospital stay, morbidity, mortality and pathologic and oncological outcomes are expressed as numbers and percentages for qualitative variables and medians and interquartile ranges (IQRs) for quantitative variables. Factors associated with recurrence risk at 12, 36 and 60 months will be evaluated using univariate and multivariate Cox regression analyses. Variables with P < 0.1 in the univariate analysis were further introduced into the multivariate analysis using the Wald selection method. TNM stage will be analyzed for its impact on DFS using the Kaplan-Meier method and the log-rank test at 12, 36 and 60 months. To determine the risk factors for the development of serious morbidity (Clavien-Dindo ≥III), we first performed univariate and multivariate logistic regression analyses. Variables with P<0.1 in the univariate analysis will be further introduced into the multivariate analysis with the Wald selection method. P values < 0.05 were considered statistically significant. This study involved the use of data from clinical records. To guarantee the proper handling of the information, the data were treated confidentially and anonymously according to the provisions of the Spanish Organic Law 15/1999, of 13 December 1999, on Personal Data Protection (LOPD). All methods were performed in accordance with the guidelines and regulations established by the Declaration of Helsinki (1964, revised in 1983) on biomedical research in humans, the Spanish Royal Decree 1090/2015, of December 4, which regulates clinical trials with drugs, the Research Ethics Committees with drugs and the Spanish Registry of Clinical Studies. Ethical approval from the Clinical Trials and Ethics Committee of Valladolid University was granted.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2022
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients diagnosed of gastric adenocarcinoma fit for surgical treatment. Exclusion Criteria: - patients who were lost to follow-up - patients unfit for surgery - palliative surgery - T4b lesions - neoplasms other than adenocarcinoma

Study Design


Locations

Country Name City State
Spain Juan Carlos Martín del Olmo Medina Del Campo Valladolid

Sponsors (1)

Lead Sponsor Collaborator
Juan Carlos Martín del Olmo

Country where clinical trial is conducted

Spain, 

References & Publications (15)

Best LM, Mughal M, Gurusamy KS. Laparoscopic versus open gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2016 Mar 31;3:CD011389. doi: 10.1002/14651858.CD011389.pub2. Review. — View Citation

GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2. Erratum in: Lancet. 2017 Oct 28;390(10106):e38. — View Citation

Guideline Committee of the Korean Gastric Cancer Association (KGCA), Development Working Group & Review Panel. Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach. J Gastric Cancer. 2019 Mar;19(1):1-48. doi: 10.5230/jgc.2019.19.e8. Epub 2019 Mar 19. Review. Erratum in: J Gastric Cancer. 2019 Sep;19(3):372-373. — View Citation

Hendriksen BS, Brooks AJ, Hollenbeak CS, Taylor MD, Reed MF, Soybel DI. The Impact of Minimally Invasive Gastrectomy on Survival in the USA. J Gastrointest Surg. 2020 May;24(5):1000-1009. doi: 10.1007/s11605-019-04263-4. Epub 2019 May 31. — View Citation

Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346. — View Citation

Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. Erratum in: Surg Laparosc Endosc. 2013 Oct;23(5):480. — View Citation

Li Z, Li B, Bai B, Yu P, Lian B, Zhao Q. Long-term outcomes of laparoscopic versus open D2 gastrectomy for advanced gastric cancer. Surg Oncol. 2018 Sep;27(3):441-448. doi: 10.1016/j.suronc.2018.05.022. Epub 2018 May 26. — View Citation

Lin JX, Lin JP, Desiderio J, Xie JW, Gemini A, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu R, Zheng CH, Li P, Parisi A, Huang CM. Difference in the short-term outcomes of laparoscopic gastrectomy for gastric carcinoma between the east and west: a retrospective study from the IMIGASTRIC trial. J Cancer. 2019 Jul 10;10(17):4106-4113. doi: 10.7150/jca.31192. eCollection 2019. — View Citation

Maida P, Marte G, Spedicato GA, Ferronetti A, Mauriello C, Canfora A, Ciorra G, Barra L, Di Maio V. Laparoscopic versus open gastrectomy with extended lymph node dissection for gastric carcinoma in a Western series: a Propensity Score Matching analysis. Minerva Chir. 2019 Feb;74(1):107-111. doi: 10.23736/S0026-4733.18.07562-4. — View Citation

Sano T, Sasako M, Yamamoto S, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K. Gastric cancer surgery: morbidity and mortality results from a prospective randomized controlled trial comparing D2 and extended para-aortic lymphadenectomy--Japan Clinical Oncology Group study 9501. J Clin Oncol. 2004 Jul 15;22(14):2767-73. Epub 2004 Jun 15. — View Citation

Shi Y, Xu X, Zhao Y, Qian F, Tang B, Hao Y, Luo H, Chen J, Yu P. Long-term oncologic outcomes of a randomized controlled trial comparing laparoscopic versus open gastrectomy with D2 lymph node dissection for advanced gastric cancer. Surgery. 2019 Jun;165(6):1211-1216. doi: 10.1016/j.surg.2019.01.003. Epub 2019 Feb 14. — View Citation

Shimada S, Sawada N, Oae S, Seki J, Takano Y, Ishiyama Y, Nakahara K, Maeda C, Hidaka E, Ishida F, Kudo SE. Safety and curability of laparoscopic gastrectomy in elderly patients with gastric cancer. Surg Endosc. 2018 Oct;32(10):4277-4283. doi: 10.1007/s00464-018-6177-1. Epub 2018 Mar 30. — View Citation

Suda K, Nakauchi M, Inaba K, Ishida Y, Uyama I. Minimally invasive surgery for upper gastrointestinal cancer: Our experience and review of the literature. World J Gastroenterol. 2016 May 21;22(19):4626-37. doi: 10.3748/wjg.v22.i19.4626. Review. — View Citation

Treitl D, Hochwald SN, Bao PQ, Unger JM, Ben-David K. Laparoscopic Total Gastrectomy with D2 Lymphadenectomy and Side-to-Side Stapled Esophagojejunostomy. J Gastrointest Surg. 2016 Aug;20(8):1523-9. doi: 10.1007/s11605-016-3162-7. Epub 2016 May 16. — View Citation

Yamamoto M, Shimokawa M, Kawano H, Ohta M, Yoshida D, Minami K, Ikebe M, Morita M, Toh Y. Benefits of laparoscopic surgery compared to open standard surgery for gastric carcinoma in elderly patients: propensity score-matching analysis. Surg Endosc. 2019 Feb;33(2):510-519. doi: 10.1007/s00464-018-6325-7. Epub 2018 Jul 20. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Operative mortality Rate of patients died in the first thirty days One month
Other Operative morbidity Rate of operative complications One month
Primary Disease-free survival at three years Rate of patients who reach this condition Three years.
Primary Disease-free survival at five years Rate of patients who reach this condition Five years
Secondary Three years overall survival Rate of patients who reach this condition Three years.
Secondary Five years overall survival Rate of patients who reach this condition Five years
See also
  Status Clinical Trial Phase
Recruiting NCT05551416 - The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Completed NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT05536102 - The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Active, not recruiting NCT04082364 - Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer Phase 2/Phase 3
Withdrawn NCT03766607 - Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT01924533 - Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. Phase 3
Terminated NCT01641939 - A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT04908813 - Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer Phase 2
Active, not recruiting NCT04249739 - Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive Phase 2
Recruiting NCT05514158 - To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) Phase 1
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2