Gastric CancerNCT04429841
D2 Versus D1 Gastrectomy of Operable Gastric Cancer
An observational study of Gastric Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Radical gastrectomy with D1 lymphadenectomy and Radical gastrectomy with D2 lymphadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2010to Jun 2020
- 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II).
Who may be able to join
- Patients younger than 80 years with a histologically confirmed operable adenocarcinoma of the stomach with complete follow up after surgery for average 5 years
Who cannot join
- Complicated gastric cancer (obstructed or perforated)
- Irresectable or metastatic disease
- Previous or coexisting cancer
- Prior gastric surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer
Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.
Read the detailed description
This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.
- Conditions
- Gastric Cancer
- Being tested
- Radical gastrectomy with D1 lymphadenectomy, Radical gastrectomy with D2 lymphadenectomy
- Keywords
- Operable Gastric Cancer, D2 Gastrectomy, D1 Gastrectomy, Operative Mortality & Morbidity, Oncological Outcomes
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical gastrectomy with D1 lymphadenectomyProcedure or surgery
Radical gastrectomy with D2 lymphadenectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| D1 Gastrectomy | Patients are managed by radical gastrectomy with D1 lymphadenectomy Receives: Procedure: Radical gastrectomy with D1 lymphadenectomy | |
| D2 Gastrectomy | Patients are managed by radical gastrectomy with D2 lymphadenectomy Receives: Procedure: Radical gastrectomy with D2 lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity rate
Frequency of early postoperative complications
Measured: 30 days after surgery
Operative mortality rate
Frequency of early postoperative mortality
Measured: 30 days after surgery
Secondary outcomes (4)
5 years Recurrence rate
Frequency of tumor recurrence within 5 years after curative surgery
Measured: 5 years after surgery
5 years Cancer specific mortality rate
Frequency of Cancer specific mortality within 5 years after curative surgery
Measured: 5 years after surgery
5 years Disease free survival rate
Percentage of patients survived for 5 years after surgery without tumor recurrence
Measured: 5 years after surgery
5 years Overall survival rate
Percentage of patients survived for 5 years after surgery with/without tumor recurrence
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study startJan 2010
- Primary completionJan 2016
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Other
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El Messiry, Alexandria University
- Investigators
- Mohamed Elmessiry, MD, Principal investigator, Assistant Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429841
- Sponsor's protocol ID
- 302764
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tamura S, Takeno A, Miki H. Lymph node dissection in curative gastrectomy for advanced gastric cancer. Int J Surg Oncol. 2011;2011:748745. doi: 10.1155/2011/748745. Epub 2011 Jun 14.
PubMed 22312521Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.
PubMed 15082726
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer
- ClinicalTrials.gov ID
- NCT04429841
- Acronym / sponsor ID
- 302764
- Conditions
- Gastric Cancer
- Keywords
- Operable Gastric Cancer, D2 Gastrectomy, D1 Gastrectomy, Operative Mortality & Morbidity, Oncological Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 12 Jun 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.
Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.
Detailed description
This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D1 Gastrectomy | – | Procedure: Radical gastrectomy with D1 lymphadenectomyPatients are managed by radical gastrectomy with D1 lymphadenectomy |
| D2 Gastrectomy | – | Procedure: Radical gastrectomy with D2 lymphadenectomyPatients are managed by radical gastrectomy with D2 lymphadenectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II).
Key inclusion criteria (1 listed)
- Patients younger than 80 years with a histologically confirmed operable adenocarcinoma of the stomach with complete follow up after surgery for average 5 years
Key exclusion criteria (4 listed)
- Complicated gastric cancer (obstructed or perforated)
- Irresectable or metastatic disease
- Previous or coexisting cancer
- Prior gastric surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical gastrectomy with D1 lymphadenectomy | Procedure or surgery | D1 Gastrectomy |
| Radical gastrectomy with D2 lymphadenectomy | Procedure or surgery | D2 Gastrectomy |
Primary outcome
Postoperative morbidity rate
Time frame: 30 days after surgery
Frequency of early postoperative complications
Operative mortality rate
Time frame: 30 days after surgery
Frequency of early postoperative mortality
4 secondary outcomes
5 years Recurrence rate
Time frame: 5 years after surgery
5 years Cancer specific mortality rate
Time frame: 5 years after surgery
5 years Disease free survival rate
Time frame: 5 years after surgery
5 years Overall survival rate
Time frame: 5 years after surgery
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 12 Jun 2020.
- Background: PubMed 22312521Tamura S, Takeno A, Miki H. Lymph node dissection in curative gastrectomy for advanced gastric cancer. Int J Surg Oncol. 2011;2011:748745. doi: 10.1155/2011/748745. Epub 2011 Jun 14.
- Background: PubMed 15082726Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.
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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.
Mohamed Elmessiry, MD principal investigator
Assistant Professor of Surgery
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, run by Alexandria University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 12 Jun 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 Egypt. 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?
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?
Postoperative morbidity rate (time frame: 30 days after surgery). 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 NCT04429841, which also lists 2 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 12 Jun 2020.