Gastric CancerLE-RACUSNCT06105515
Laparoscopic and Endoscopic Collaborative Surgery as Rescue-treatment for Advanced Gastric Cancer
A study testing Laparoscopic and Endoscopic Collaborative Surgery (LECS) in people with Gastric Cancer, run by Region Stockholm at 1 site in Sweden.
Trial summary
The standard treatment for advanced gastric cancer without metastases is gastrectomy, where the whole stomach or a large proportion is removed surgically together with regional lymph nodes. Some patients cannot tolerate this invasive procedure because of old age or comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Laparoscopic and Endoscopic Collaborative Surgery (LECS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 17 Apr 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pT2-T4aN0M0 gastric carcinoma
- Borrmann type 1-2 < 5 cm or Borrmann type 3 < 2 cm
- Patient assessment by the multidisciplinary tumor board as not fit for gastrectomy
- Signed informed consent
Who cannot join
- Borrman type 4
- Location in the cardia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 14186
Ioannis Rouvelas, Dr, ioannis.rouvelas@ki.se
Henrik Maltzman, Dr, henrik.maltzman@regionstockholm.se
About this study
Official title: Laparoscopic and Endoscopic Collaborative Surgery as Rescue-treatment for Advanced Gastric Cancer in Patients Unfit for Surgery - the LE-RACUS Pilot Clinical Study
The standard treatment for advanced gastric cancer without metastases is gastrectomy, where the whole stomach or a large proportion is removed surgically together with regional lymph nodes. Some patients cannot tolerate this invasive procedure because of old age or comorbidities. A tumor left in place can cause local symptoms such as bleeding or outlet obstruction. In this study, the investigators want to test the safety and feasibility of Laparoscopic and Endoscopic Collaborative Surgery (LECS) as a less invasive treatment option to locally remove gastric tumors without requiring extensive surgery in these frail patients. LECS is a minimally invasive surgical technique where the tumor margin is first marked from the inside with a gastroscope, followed by surgical removal of the lesion under endoscopic guidance.
Read the detailed description
In patients with advanced gastric cancer (AGC), laparoscopic gastrectomy with lymph node dissection in combination with chemotherapy is the recommended treatment for cases with curative intent. However, some patients cannot tolerate such demanding treatment because of comorbidities or advanced age. If gastrectomy or palliative chemotherapy cannot be offered the only remaining alternative is best supportive care.
Patients with AGC that cannot receive definitive surgical or oncological treatment can develop complications such as bleeding from the primary tumor or gastric outlet obstruction. Such complications can be difficult to manage by endoscopic means, and significantly impact the patients' quality of life.
Laparoscopic and endoscopic collaborative surgery (LECS) was reported by Hiki et al in 2008 as a treatment for submucosal tumors. With this method, the endoscopist first performs mucosal incision around the tumor followed by laparoscopic removal of the tumor with endoscopic guidance.
In Japan, the current indication for LECS is gastrointestinal stromal cell tumors with a size of 2-5 cm. LECS has also been described in two case reports as palliative treatment for patients with AGC without being in a state to undergo gastrectomy. To the best of the investigators' knowledge, no prospective trial has studied LECS for this indication. Compared with gastrectomy, LECS is a very safe and much less invasive technique with few severe adverse events. If the tumor could be completely resected with LECS, the risk for bleeding and other tumor-related complications could be diminished which could significantly benefit the patients and improve their quality of life.
In this study, the investigators want to test the safety and feasibility of performing LECS for patients who are unfit for standard treatment with gastrectomy. The patients will be screened for inclusion through a multidisciplinary team meeting. If they meet the inclusion criteria they will be asked to participate in the study on an outpatient meeting with a member of the research team. If the patient agrees to participate and can sign an informed consent, they will be booked for a LECS procedure. After the operation is performed, the patient will meet the researcher again 4-6 weeks later and will be asked to fill in two QoL questionnaires.
- Conditions
- Gastric Cancer
- Being tested
- Laparoscopic and Endoscopic Collaborative Surgery (LECS)
- Keywords
- Laparoscopic and endoscopic collaborative surgery, Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic and Endoscopic Collaborative Surgery (LECS)Procedure or surgery
Minimal invasive surgery in collaboration between endoscopy and laparoscopic surgery, to locally remove the tumor
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | The group that will receive the active treatment Receives: Procedure: Laparoscopic and Endoscopic Collaborative Surgery (LECS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe complication
Clavien Dindo complication grade >/= III
Measured: Through study completion, an average of 2 years
Secondary outcomes (5)
Any complication
Clavien Dindo complication grade II-IV
Measured: Through study completion, an average of 2 years
Postoperative bleeding/leakage/postoperative abcess
Use of blood transfusion/abcess requiring drainage
Measured: Through study completion, an average of 2 years
Operation time/local radicality
Time of the surgical procedure/pathology report of radical resection
Measured: Through study completion, an average of 2 years
30-day mortality/in-hospital mortality/hospital-stay
Mortality within 30 days/mortality during the hospital stay/number of days admitted
Measured: Through study completion, an average of 2 years
Health-related quality of life
The QLQ-C30/OG25 HQL questionnaire
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start17 Apr 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 Region StockholmThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ioannis Rouvelas, Region Stockholm
- Investigators
- Ioannis Rouvelas, MD, PhD, Principal investigator, ME Övre buk, Karolinska Universitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105515
- Sponsor's protocol ID
- U1111-1298-9641
- Acronym
- LE-RACUS
- Status last verified
- Jul 2025
- First submitted
- 23 Oct 2023
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Yu F, Wu L, Ye F, Zhang L, Li Y. Survival after Gastrectomy in Node-Negative Gastric Cancer: A Review and Meta-Analysis of Prognostic Factors. Med Sci Monit. 2015 Jul 2;21:1911-9. doi: 10.12659/MSM.893856.
PubMed 26134762Hiki N, Yamamoto Y, Fukunaga T, Yamaguchi T, Nunobe S, Tokunaga M, Miki A, Ohyama S, Seto Y. Laparoscopic and endoscopic cooperative surgery for gastrointestinal stromal tumor dissection. Surg Endosc. 2008 Jul;22(7):1729-35. doi: 10.1007/s00464-007-9696-8. Epub 2007 Dec 12.
PubMed 18074180Takechi H, Fujikuni N, Takemoto Y, Tanabe K, Amano H, Noriyuki T, Nakahara M. Palliative surgery for advanced gastric cancer: Partial gastrectomy using the inverted laparoscopic and endoscopic cooperative surgery method. Int J Surg Case Rep. 2018;50:42-45. doi: 10.1016/j.ijscr.2018.06.042. Epub 2018 Jul 21.
PubMed 30077165Washio M, Hiki N, Hosoda K, Niihara M, Chuman M, Sakuraya M, Wada T, Harada H, Sato T, Tanaka K, Naitoh T, Kumamoto Y, Sangai T, Tanabe S, Yamashita K. Laparoscopic and endoscopic cooperative surgery for advanced gastric cancer as palliative surgery in elderly patients: a case report. Surg Case Rep. 2021 Nov 15;7(1):241. doi: 10.1186/s40792-021-01325-1.
PubMed 34779942de Brito SO, Libanio D, Pinto CMM, de Araujo Teixeira JPPO, de Araujo Teixeira JPM. Efficacy and Safety of Laparoscopic Endoscopic Cooperative Surgery in Upper Gastrointestinal Lesions: A Systematic Review and Meta-Analysis. GE Port J Gastroenterol. 2022 Nov 7;30(1):4-19. doi: 10.1159/000526644. eCollection 2023 Jan.
PubMed 36743984Maltzman H, Omae M, Klevebro F, Baldaque-Silva F, Rouvelas I. Laparoscopic and Endoscopic cooperative surgery as Rescue-treatment for Advanced gastric Cancer in patients Unfit for Surgery (LE-RACUS): protocol for a feasibility study. Pilot Feasibility Stud. 2025 Jan 3;11(1):1. doi: 10.1186/s40814-024-01584-3.
PubMed 39754254
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic and Endoscopic Collaborative Surgery as Rescue-treatment for Advanced Gastric Cancer in Patients Unfit for Surgery - the LE-RACUS Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT06105515
- Acronym / sponsor ID
- LE-RACUS / U1111-1298-9641
- Conditions
- Gastric Cancer
- Keywords
- Laparoscopic and endoscopic collaborative surgery, Gastric cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 27 Oct 2023 (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.
The standard treatment for advanced gastric cancer without metastases is gastrectomy, where the whole stomach or a large proportion is removed surgically together with regional lymph nodes. Some patients cannot tolerate this invasive procedure because of old age or comorbidities. A tumor left in place can cause local symptoms such as bleeding or outlet obstruction. In this study, the investigators want to test the safety and feasibility of Laparoscopic and Endoscopic Collaborative Surgery (LECS) as a less invasive treatment option to locally remove gastric tumors without requiring extensive surgery in these frail patients. LECS is a minimally invasive surgical technique where the tumor margin is first marked from the inside with a gastroscope, followed by surgical removal of the lesion under endoscopic guidance.
Detailed description
In patients with advanced gastric cancer (AGC), laparoscopic gastrectomy with lymph node dissection in combination with chemotherapy is the recommended treatment for cases with curative intent. However, some patients cannot tolerate such demanding treatment because of comorbidities or advanced age. If gastrectomy or palliative chemotherapy cannot be offered the only remaining alternative is best supportive care.
Patients with AGC that cannot receive definitive surgical or oncological treatment can develop complications such as bleeding from the primary tumor or gastric outlet obstruction. Such complications can be difficult to manage by endoscopic means, and significantly impact the patients' quality of life.
Laparoscopic and endoscopic collaborative surgery (LECS) was reported by Hiki et al in 2008 as a treatment for submucosal tumors. With this method, the endoscopist first performs mucosal incision around the tumor followed by laparoscopic removal of the tumor with endoscopic guidance.
In Japan, the current indication for LECS is gastrointestinal stromal cell tumors with a size of 2-5 cm. LECS has also been described in two case reports as palliative treatment for patients with AGC without being in a state to undergo gastrectomy. To the best of the investigators' knowledge, no prospective trial has studied LECS for this indication. Compared with gastrectomy, LECS is a very safe and much less invasive technique with few severe adverse events. If the tumor could be completely resected with LECS, the risk for bleeding and other tumor-related complications could be diminished which could significantly benefit the patients and improve their quality of life.
In this study, the investigators want to test the safety and feasibility of performing LECS for patients who are unfit for standard treatment with gastrectomy. The patients will be screened for inclusion through a multidisciplinary team meeting. If they meet the inclusion criteria they will be asked to participate in the study on an outpatient meeting with a member of the research team. If the patient agrees to participate and can sign an informed consent, they will be booked for a LECS procedure. After the operation is performed, the patient will meet the researcher again 4-6 weeks later and will be asked to fill in two QoL questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Procedure: Laparoscopic and Endoscopic Collaborative Surgery (LECS)The group that will receive the active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pT2-T4aN0M0 gastric carcinoma
- Borrmann type 1-2 < 5 cm or Borrmann type 3 < 2 cm
- Patient assessment by the multidisciplinary tumor board as not fit for gastrectomy
- Signed informed consent
Key exclusion criteria (2 listed)
- Borrman type 4
- Location in the cardia
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 |
|---|---|---|
| Laparoscopic and Endoscopic Collaborative Surgery (LECS)Minimal invasive surgery in collaboration between endoscopy and laparoscopic surgery, to locally remove the tumor | Procedure or surgery | Interventional arm |
Primary outcome
Severe complication
Time frame: Through study completion, an average of 2 years
Clavien Dindo complication grade >/= III
5 secondary outcomes
Any complication
Time frame: Through study completion, an average of 2 years
Postoperative bleeding/leakage/postoperative abcess
Time frame: Through study completion, an average of 2 years
Operation time/local radicality
Time frame: Through study completion, an average of 2 years
30-day mortality/in-hospital mortality/hospital-stay
Time frame: Through study completion, an average of 2 years
Health-related quality of life
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 26134762Zhou Y, Yu F, Wu L, Ye F, Zhang L, Li Y. Survival after Gastrectomy in Node-Negative Gastric Cancer: A Review and Meta-Analysis of Prognostic Factors. Med Sci Monit. 2015 Jul 2;21:1911-9. doi: 10.12659/MSM.893856.
- Background: PubMed 18074180Hiki N, Yamamoto Y, Fukunaga T, Yamaguchi T, Nunobe S, Tokunaga M, Miki A, Ohyama S, Seto Y. Laparoscopic and endoscopic cooperative surgery for gastrointestinal stromal tumor dissection. Surg Endosc. 2008 Jul;22(7):1729-35. doi: 10.1007/s00464-007-9696-8. Epub 2007 Dec 12.
- Background: PubMed 30077165Takechi H, Fujikuni N, Takemoto Y, Tanabe K, Amano H, Noriyuki T, Nakahara M. Palliative surgery for advanced gastric cancer: Partial gastrectomy using the inverted laparoscopic and endoscopic cooperative surgery method. Int J Surg Case Rep. 2018;50:42-45. doi: 10.1016/j.ijscr.2018.06.042. Epub 2018 Jul 21.
- Background: PubMed 34779942Washio M, Hiki N, Hosoda K, Niihara M, Chuman M, Sakuraya M, Wada T, Harada H, Sato T, Tanaka K, Naitoh T, Kumamoto Y, Sangai T, Tanabe S, Yamashita K. Laparoscopic and endoscopic cooperative surgery for advanced gastric cancer as palliative surgery in elderly patients: a case report. Surg Case Rep. 2021 Nov 15;7(1):241. doi: 10.1186/s40792-021-01325-1.
- Background: PubMed 36743984de Brito SO, Libanio D, Pinto CMM, de Araujo Teixeira JPPO, de Araujo Teixeira JPM. Efficacy and Safety of Laparoscopic Endoscopic Cooperative Surgery in Upper Gastrointestinal Lesions: A Systematic Review and Meta-Analysis. GE Port J Gastroenterol. 2022 Nov 7;30(1):4-19. doi: 10.1159/000526644. eCollection 2023 Jan.
- Derived from this study: PubMed 39754254Maltzman H, Omae M, Klevebro F, Baldaque-Silva F, Rouvelas I. Laparoscopic and Endoscopic cooperative surgery as Rescue-treatment for Advanced gastric Cancer in patients Unfit for Surgery (LE-RACUS): protocol for a feasibility study. Pilot Feasibility Stud. 2025 Jan 3;11(1):1. doi: 10.1186/s40814-024-01584-3.
- 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.
Ioannis Rouvelas, MD, PhD principal investigator
ME Övre buk, Karolinska Universitetssjukhuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic and Endoscopic Collaborative Surgery (LECS) in people with Gastric Cancer, run by Region Stockholm at 1 site in Sweden.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Jul 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ioannis Rouvelas, MD, PhD (+46707976814, ioannis.rouvals@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe complication (time frame: Through study completion, an average of 2 years). 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 NCT06105515, which also lists 6 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 22 Jul 2025.