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Trial Title:
Laparoscopic and Endoscopic Collaborative Surgery as Rescue-treatment for Advanced Gastric Cancer
NCT ID:
NCT06105515
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Laparoscopic and endoscopic collaborative surgery
Gastric cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic and Endoscopic Collaborative Surgery (LECS)
Description:
Minimal invasive surgery in collaboration between endoscopy and laparoscopic surgery, to
locally remove the tumor
Arm group label:
Interventional arm
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Borrman type 4
- Location in the cardia
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Zip:
14186
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Ioannis Rouvelas, Dr
Email:
ioannis.rouvelas@ki.se
Contact backup:
Last name:
Henrik Maltzman, Dr
Email:
henrik.maltzman@regionstockholm.se
Start date:
April 17, 2024
Completion date:
February 1, 2027
Lead sponsor:
Agency:
Region Stockholm
Agency class:
Other
Source:
Region Stockholm
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06105515
