Early Gastric Cancer
Conditions
Keywords
sentinel node-resection, minimal invasive surgery
Brief summary
For patients with non-curative resection after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC), complementary surgery is generally recommended. However, about 2/3 of patients have no remaining tumor in the stomach or regional lymph nodes. In this trial, Indocyanine Green (ICG)-guided lymphadenectomy with or without laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive alternative in such cases. For patients with a primary radically resected EGC, ICG-guided lymphadenectomy alone will be performed. For patients with deep-margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed, in order to ensure both local tumor control in the stomach and in regional nodes.
Detailed description
Endoscopic submucosal dissection (ESD) is the recommended treatment for early gastric cancer (EGC) who are fullfillling the criteria based on international guidelines. After ESD, some resections are classified as non-curative because of factors such as non radicality (especially when the deep margin is positive for cancer), lymphovascular invasion or deep submucosal invasion Sm\>1. In such cases, guidelines recommend complementary gastrectomy and lymphadenectomy. Gastrectomy is known to carry a risk for severe complications in about 9-22 % of cases. Furthermore, up to 2/3 of patients are found to have no remaining tumor in the stomach or regional nodes after surgery. In this trial, Indocyanine Green (ICG)-guided lymphadenectomy including sentinel node resection, with or without complementary laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive treatment option. For patients with radically resected EGC, ICG-guided lymphadenectomy alone will be performed. In patients with deep margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed. ICG-guided lymphadenectomy is performed by first injecting 100 times diluted ICG in four quadrants in the submucosa around the tumor scar with gastroscopy. After 15 minutes, the draining nodes will be visualized with laparoscopy, and locally resected. LECS is performed by endoscopic marking of the scar followed circumferential mucosal cutting, trimming, and perforation of the stomach followed by full-thickness resection of the scar with laparoscopy. After resection, the resected specimen will be taken out and the stomach defect sutured laparoscopically. After the procedure, the patient will be presented at a multidisciplinary tumor board. If only clinical follow-up is recommended, the patient will be followed closely with gastroscopy and computer tomography (CT) scan every 3 months for the first year.
Interventions
PROCEDUREICG-guided lymphadenectomy
Submucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes
PROCEDURELaparoscopic and endoscopic cooperative surgery (LECS)
Endoscopic marking and submucosal cutting around the scar after ESD, followed by perforation of the gastric wall and laparoscopic full thickness resection of the area under endoscopic guidance.
Sponsors
Region Stockholm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* EGC previously treated with ESD according to current guidelines (differentiated adenocarcinoma, not ulcerative, of any size, differentiated adenocarcinoma ulcerative \</=3cm, undifferentiated adenocarcinoma not ulcerative \</=2cm) * Non curative resection * Lymphovascular invasion * Non-radical resection vertical margin * deep submucosal invasion * Signed informed consent
Exclusion criteria
* Location within 2 cm from cardia or pylorus * Non-curative resection with only non-radicality horizontal margin * Inoperative because of severe comorbidities * Previous radiotherapy to the upper abdomen * Pregnancy * Allergy to ICG * Inability to provide informed consent due to cognitive impairment, language barrier, or other reasons impairing understanding and autonomous decision-making.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe complications defined as Clavien-Dindo >/= III | Periprocedural | Safety of the procedure, defined as Clavien-Dindo complication grade \>/= III |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative bleeding | Periprocedural | Postoperative bleeding requiring blood transfusion |
| Leakage | Periprocedural | Leakage/postoperative abscess requiring drainage |
| Operation time | Periprocedural | Time of the surgical procedure |
| Pathological tumor (T)-stage | Up to 2 months post procedure | Depth of tumor invasion into the gastric wall (for LECS cases) |
| Tumor-free resection margins | Up to 2 months post procedure | The rate of horizontal and vertical margins free of tumor cells (for LECS cases). |
| Number of lymph nodes | Periprocedural | Number of lymph nodes harvested during the procedure |
| Any complications | Periprocedural | Any complication during the procedure (Clavien-Dindo II-IV) |
| Hospital-stay | From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure | Number of days from the procedure until discharge |
| Health-related quality of life (HQL) score QLQ-30 | Preoperatively, after 30 days and 1 year | Pre and postoperative HQL, tested with the validated score QLQ-C30 (The EORTC QLG Core Questionnaire for cancer patients) |
| Health-related quality of life (HQL) score OG25 | Preoperatively, after 30 days and 1 year | Pre and postoperative HQL, tested with the validated score OG25 (The EORTC QLG Module Questionnaire specifically for esophago-gastric patients) |
| 30-day mortality | From procedure to maximum 30 days postoperatively | 30-day mortality |
| In-hospital mortality | From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure | In-hospital mortality |
| 1-year disease-free survival | Until 1 year after the procedure | 1-year disease-free survival |
| Number of positive lymph nodes | Up to 2 months post procedure | Number of lymph nodes positive for cancer |
Countries
Sweden
Contacts
Primary ContactIoannis Rouvelas, MD, PhD
Backup ContactHenrik Maltzman, MD
Outcome results
None listed