Gastric CancerNCT04652986
Outcomes of Laparoscopic Gastrectomy
An observational study of Gastric Cancer and Laparoscopic Gastrectomy, run by Juan Carlos Martín del Olmo at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Laparoscopic Gastrectomy
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2004to Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed of gastric adenocarcinoma in the area care of Medina del Campo Hospital.
Who may be able to join
- Patients diagnosed of gastric adenocarcinoma fit for surgical treatment.
Who cannot join
- patients who were lost to follow-up
- patients unfit for surgery
- palliative surgery
- T4b lesions
- neoplasms other than adenocarcinoma
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Juan Carlos Martín del Olmo
Medina del Campo, Valladolid, 47400
Juan Carlos Martín del Olmo, MD,PhD, +34 629646199, jcmolmo@gmail.com
Juan Ramón Gómez López, MD,PhD
About this study
Official title: Mid- and Long-term Surgical and Oncological Outcomes of Total Laparoscopic Gastrectomy for Gastric Cancer: A Prospective Study
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.
Read the detailed 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.
- Conditions
- Gastric Cancer, Laparoscopic Gastrectomy
- Keywords
- Gastric cancer, Laparoscopy, Gastrectomy
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival at three years
Rate of patients who reach this condition
Measured: Three years.
Disease-free survival at five years
Rate of patients who reach this condition
Measured: Five years
Secondary outcomes (2)
Three years overall survival
Rate of patients who reach this condition
Measured: Three years.
Five years overall survival
Rate of patients who reach this condition
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study startJan 2004
- Primary completionNov 2020
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Carlos Martín del Olmo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Carlos Martín del Olmo, Hospital Medina del Campo
- Investigators
- Juan Carlos Martín del Olmo, MD,PhD, Study director, Hospital de Medina del Campo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652986
- Sponsor's protocol ID
- HMCampo
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27217695Best LM, Mughal M, Gurusamy KS. Laparoscopic versus open gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2016 Mar 31;3(3):CD011389. doi: 10.1002/14651858.CD011389.pub2.
PubMed 27030300GBD 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.
PubMed 28919117Li 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.
PubMed 30217300Sano 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. doi: 10.1200/JCO.2004.10.184. Epub 2004 Jun 15.
PubMed 15199090Hendriksen 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.
PubMed 31152343Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
PubMed 8180768Lin 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.
PubMed 31417655Maida 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. No abstract available.
PubMed 30646677Treitl 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.
PubMed 27184675Guideline 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. No abstract available.
PubMed 30944757Yamamoto 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.
PubMed 30030615Kim 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.
PubMed 26352529Shi 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.
PubMed 30772006Shimada 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.
PubMed 29602987
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid- and Long-term Surgical and Oncological Outcomes of Total Laparoscopic Gastrectomy for Gastric Cancer: A Prospective Study
- ClinicalTrials.gov ID
- NCT04652986
- Acronym / sponsor ID
- HMCampo
- Conditions
- Gastric Cancer, Laparoscopic Gastrectomy
- Keywords
- Gastric cancer, Laparoscopy, Gastrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Juan Carlos Martín del OlmoUniversity, hospital or other
- Study start
- Jan 2004 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Dec 2020 (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.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed of gastric adenocarcinoma in the area care of Medina del Campo Hospital.
Key inclusion criteria (1 listed)
- Patients diagnosed of gastric adenocarcinoma fit for surgical treatment.
Key exclusion criteria (5 listed)
- patients who were lost to follow-up
- patients unfit for surgery
- palliative surgery
- T4b lesions
- neoplasms other than adenocarcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-free survival at three years
Time frame: Three years.
Rate of patients who reach this condition
Disease-free survival at five years
Time frame: Five years
Rate of patients who reach this condition
2 secondary outcomes
Three years overall survival
Time frame: Three years.
Five years overall survival
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Background: PubMed 27217695Suda 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.
- Background: PubMed 27030300Best LM, Mughal M, Gurusamy KS. Laparoscopic versus open gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2016 Mar 31;3(3):CD011389. doi: 10.1002/14651858.CD011389.pub2.
- Background: PubMed 28919117GBD 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.
- Background: PubMed 30217300Li 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.
- Background: PubMed 15199090Sano 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. doi: 10.1200/JCO.2004.10.184. Epub 2004 Jun 15.
- Background: PubMed 31152343Hendriksen 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.
- Background: PubMed 8180768Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
- Background: PubMed 31417655Lin 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.
- Background: PubMed 30646677Maida 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. No abstract available.
- Background: PubMed 27184675Treitl 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.
- Background: PubMed 30944757Guideline 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. No abstract available.
- Background: PubMed 30030615Yamamoto 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.
- 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.
Juan Carlos Martín del Olmo, MD,PhD study director
Hospital de Medina del Campo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Laparoscopic Gastrectomy, run by Juan Carlos Martín del Olmo at 1 site in Spain.
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 1 inclusion and 5 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 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Juan Carlos Martín del Olmo, MD,PhD (+34 629646199, jcmolmo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival at three years (time frame: Three years.). 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 NCT04652986, which also lists 15 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 4 Dec 2020.