Health TrialsbyHealthPanel

Sentinel Node Resection With or Without LECS After Noncurative ESD for EGC

ConditionEarly Gastric Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • ICG-guided lymphadenectomy

    Procedure/Surgery

    Submucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes

  • Laparoscopic and endoscopic cooperative surgery (LECS)

    Procedure/Surgery

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: ICG-guided lymphadenectomy +/- LECSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Severe complications defined as Clavien-Dindo >/= III

Safety of the procedure, defined as Clavien-Dindo complication grade \>/= III

Time frame
Periprocedural

Secondary outcomes

1

Any complications

Any complication during the procedure (Clavien-Dindo II-IV)

Time frame
Periprocedural
2

Postoperative bleeding

Postoperative bleeding requiring blood transfusion

Time frame
Periprocedural
3

Leakage

Leakage/postoperative abscess requiring drainage

Time frame
Periprocedural
4

Operation time

Time of the surgical procedure

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: