Gastric CancerNCT05068635
Evaluation of the Efficacy of Distal Gastrectomy for the Treatment of Gastric Cancer (a Case Series)
An observational study of Gastric Cancer, run by Sylvestre KABURA.
Trial summary
Case series of a retrospective study of patients operated for distal adenocarcinoma of the stomach, either by total gastrectomy or distal gastrectomy at Ibn Rochd University Hospital in Casablanca, with the analysis of outcome of patients on a follow up periode of three years and eight months. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Aug 2021
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study concerns patients who have been treated in our service for gastric cancer from fifteen years to unlimited age
Inclusion Criteria: Patients bwith gastric cancer with histologic confirmation
Exclusion Criteria: Incomplete patients records
About this study
Case series of a retrospective study of patients operated for distal adenocarcinoma of the stomach, either by total gastrectomy or distal gastrectomy at Ibn Rochd University Hospital in Casablanca, with the analysis of outcome of patients on a follow up periode of three years and eight months.
Read the detailed description
Thirty (30) patients were treated for gastric cancer and were included in this study. The average age was 64 years, the sex ratio 1.5. Twenty eight patients underwent a distal gastrectomy and 2 patients underwent total gastrectomy. The median number of lymph nodes resected was 6 following distal gastrectomy versus 26 after total gastrectomy. Resection margins were clean except for three patients who underwent a distal gastrectomy. Postoperative complicationsoccured in 05 patients. They were mainly infectious, anastomotic leakage. Two 2 cases of postoperative mortality (<30 days) among patients with distal gastrectomy was noted. A progression to metastasis was found in 3 patients with subtotal gastrectomy, two of whom had insufficient lymph node clearance, compared to no cases of metastasis in patients with total gastrectomy.
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, gastric adenocarcinoma, total gastrectomy, subtotal gastrectomy, distal gastrectomy.
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who died for gastric cancer after distal gastrectomy
Mortality rate for patients who underwent distal gastrectomy for gastric cancer
Measured: Fourty four months
Number of patients who developped morbidity after subgastrectmy for gastric cancer
Mortality rate for patients who underwent distal gastrectomy for gastric cancer
Measured: Forty for months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Jan 2013
- Primary completion31 Dec 2017
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylvestre KABURA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sylvestre KABURA, Centre Hospitalier Universitaire Ibn Rochd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068635
- Sponsor's protocol ID
- SK2021
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Distal Gastrectomy for the Treatment of Gastric Cancer (a Case Series)
- ClinicalTrials.gov ID
- NCT05068635
- Acronym / sponsor ID
- SK2021
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, gastric adenocarcinoma, total gastrectomy, subtotal gastrectomy, distal gastrectomy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sylvestre KABURAUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 Oct 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.
Case series of a retrospective study of patients operated for distal adenocarcinoma of the stomach, either by total gastrectomy or distal gastrectomy at Ibn Rochd University Hospital in Casablanca, with the analysis of outcome of patients on a follow up periode of three years and eight months.
Detailed description
Thirty (30) patients were treated for gastric cancer and were included in this study. The average age was 64 years, the sex ratio 1.5. Twenty eight patients underwent a distal gastrectomy and 2 patients underwent total gastrectomy. The median number of lymph nodes resected was 6 following distal gastrectomy versus 26 after total gastrectomy. Resection margins were clean except for three patients who underwent a distal gastrectomy. Postoperative complicationsoccured in 05 patients. They were mainly infectious, anastomotic leakage. Two 2 cases of postoperative mortality (<30 days) among patients with distal gastrectomy was noted. A progression to metastasis was found in 3 patients with subtotal gastrectomy, two of whom had insufficient lymph node clearance, compared to no cases of metastasis in patients with total gastrectomy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study concerns patients who have been treated in our service for gastric cancer from fifteen years to unlimited age
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
Number of patients who died for gastric cancer after distal gastrectomy
Time frame: Fourty four months
Mortality rate for patients who underwent distal gastrectomy for gastric cancer
Number of patients who developped morbidity after subgastrectmy for gastric cancer
Time frame: Forty for months
Mortality rate for patients who underwent distal gastrectomy for gastric cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Sylvestre KABURA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 6 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who died for gastric cancer after distal gastrectomy (time frame: Fourty four months). 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?
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 6 Oct 2021.