Gastric CancerNCT06281379
Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer:
A study testing Total mesogastrectomy in people with Gastric Cancer and Gastric Neoplasm, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population. Study design:Randomised-controlled study Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Gastric Neoplasm, Gastric Cancer Stage
- What is being tested?
- Total mesogastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Jan 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients with histopathologically confirmed gastric adenocancer without evidence of distal metastasis and resectable tumors which have been treated with open total gastrectomy.
Who cannot join
- Patients with prior upper gastrointestinal system surgery
- Patients with neoadjuvant therapy
- Patients with peripheral organ involvement and/or distant metastasis
- Patients who underwent subtotal gastrectomy
- Patients who underwent laparoscopic and robotic operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Results of a Randomized Controlled Trial and Review of the Literature Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer: Short-term Results of a Randomized Controlled Trial and Review of the Literature
Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.
Study design:Randomised-controlled study
Read more
Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.
Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.
Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization.
Read the detailed description
The curative treatment of gastrointestinal tumors is surgery referring to an en block resection of the primary tumor along with its lymphovascular drainage.Unfortunately, despite of these radical resections, published literature shows that recurrences occur in up to 38% of patients in 5 years. Morover, these rates may reach to 60% in patients with locally advanced tumor following radical surgery. However, this mesentery-based surgery is harder to apply in gastric cancer due to differences in embriyological development. In our prospective study and a review of the literature, following the descripiton of mesogastrium concept, we aimed to search and analyse former techniques and viewpoints about mesogastric excision by different surgical approaches from various countries. Later, we aimed to show our technique of mesogastrectomy, compared our short term results with limited publications from the literature.
- Conditions
- Gastric Cancer, Gastric Neoplasm, Gastric Cancer Stage
- Being tested
- Total mesogastrectomy
- Keywords
- Gastric cancer, D2 lymph node dissection, Mesogastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total mesogastrectomyProcedure or surgery
More extended resection type with better oncological outcomes when compared to standard technique
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Total gastrectomy+mesogastrectomy Receives: Procedure: Total mesogastrectomy |
| Group 2 | Other | Total gastrectomy with concentional D2 lymphadenectomy Receives: Procedure: Total mesogastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative outcome
Complications
Measured: Postoperative 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Apr 2023
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study group participants: total gastrectomy+mesogastrectomy Control group: Standard total gastrectomy + D2 lymph node dissection
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281379
- Sponsor's protocol ID
- Basaksehir City Hospital
- Status last verified
- Feb 2024
- First submitted
- 17 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Xie D, Gao C, Lu A, Liu L, Yu C, Hu J, Gong J. Proximal segmentation of the dorsal mesogastrium reveals new anatomical implications for laparoscopic surgery. Sci Rep. 2015 Nov 6;5:16287. doi: 10.1038/srep16287.
PubMed 26542081Girnyi S, Ekman M, Marano L, Roviello F, Polom K. Complete Mesogastric Excisions Involving Anatomically Based Concepts and Embryological-Based Surgeries: Current Knowledge and Future Challenges. Curr Oncol. 2021 Nov 22;28(6):4929-4937. doi: 10.3390/curroncol28060413.
PubMed 34898586Shinohara H, Kurahashi Y, Haruta S, Ishida Y, Sasako M. Universalization of the operative strategy by systematic mesogastric excision for stomach cancer with that for total mesorectal excision and complete mesocolic excision colorectal counterparts. Ann Gastroenterol Surg. 2017 Oct 23;2(1):28-36. doi: 10.1002/ags3.12048. eCollection 2018 Jan.
PubMed 29863126Xie D, Osaiweran H, Liu L, Wang X, Yu C, Tong Y, Hu J, Gong J. Mesogastrium: a fifth route of metastasis in gastric cancer? Med Hypotheses. 2013 Apr;80(4):498-500. doi: 10.1016/j.mehy.2012.12.020. Epub 2013 Feb 10.
PubMed 23403142
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Results of a Randomized Controlled Trial and Review of the Literature Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer: Short-term Results of a Randomized Controlled Trial and Review of the Literature
- ClinicalTrials.gov ID
- NCT06281379
- Acronym / sponsor ID
- Basaksehir City Hospital
- Conditions
- Gastric Cancer, Gastric Neoplasm, Gastric Cancer Stage
- Keywords
- Gastric cancer, D2 lymph node dissection, Mesogastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 28 Feb 2024 (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.
Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.
Study design:Randomised-controlled study
Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.
Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.
Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization.
Detailed description
The curative treatment of gastrointestinal tumors is surgery referring to an en block resection of the primary tumor along with its lymphovascular drainage.Unfortunately, despite of these radical resections, published literature shows that recurrences occur in up to 38% of patients in 5 years. Morover, these rates may reach to 60% in patients with locally advanced tumor following radical surgery. However, this mesentery-based surgery is harder to apply in gastric cancer due to differences in embriyological development. In our prospective study and a review of the literature, following the descripiton of mesogastrium concept, we aimed to search and analyse former techniques and viewpoints about mesogastric excision by different surgical approaches from various countries. Later, we aimed to show our technique of mesogastrectomy, compared our short term results with limited publications from the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study group participants: total gastrectomy+mesogastrectomy Control group: Standard total gastrectomy + D2 lymph node dissection
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Total mesogastrectomyTotal gastrectomy+mesogastrectomy |
| Group 2 | Other | Procedure: Total mesogastrectomyTotal gastrectomy with concentional D2 lymphadenectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with histopathologically confirmed gastric adenocancer without evidence of distal metastasis and resectable tumors which have been treated with open total gastrectomy.
Key exclusion criteria (5 listed)
- Patients with prior upper gastrointestinal system surgery
- Patients with neoadjuvant therapy
- Patients with peripheral organ involvement and/or distant metastasis
- Patients who underwent subtotal gastrectomy
- Patients who underwent laparoscopic and robotic operations
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 |
|---|---|---|
| Total mesogastrectomyMore extended resection type with better oncological outcomes when compared to standard technique | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Postoperative outcome
Time frame: Postoperative 1 week
Complications
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 28 Feb 2024.
- Background: PubMed 26542081Xie D, Gao C, Lu A, Liu L, Yu C, Hu J, Gong J. Proximal segmentation of the dorsal mesogastrium reveals new anatomical implications for laparoscopic surgery. Sci Rep. 2015 Nov 6;5:16287. doi: 10.1038/srep16287.
- Background: PubMed 34898586Girnyi S, Ekman M, Marano L, Roviello F, Polom K. Complete Mesogastric Excisions Involving Anatomically Based Concepts and Embryological-Based Surgeries: Current Knowledge and Future Challenges. Curr Oncol. 2021 Nov 22;28(6):4929-4937. doi: 10.3390/curroncol28060413.
- Background: PubMed 29863126Shinohara H, Kurahashi Y, Haruta S, Ishida Y, Sasako M. Universalization of the operative strategy by systematic mesogastric excision for stomach cancer with that for total mesorectal excision and complete mesocolic excision colorectal counterparts. Ann Gastroenterol Surg. 2017 Oct 23;2(1):28-36. doi: 10.1002/ags3.12048. eCollection 2018 Jan.
- Results publication: PubMed 23403142Xie D, Osaiweran H, Liu L, Wang X, Yu C, Tong Y, Hu J, Gong J. Mesogastrium: a fifth route of metastasis in gastric cancer? Med Hypotheses. 2013 Apr;80(4):498-500. doi: 10.1016/j.mehy.2012.12.020. Epub 2013 Feb 10.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total mesogastrectomy in people with Gastric Cancer and Gastric Neoplasm, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Turkey (Türkiye). 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 outcome (time frame: Postoperative 1 week). 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 NCT06281379, which also lists 4 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 28 Feb 2024.