Comparison Partial Versus Total Omentectomy in Minimal Invasive Distal Gastrectomy for cT3/4a Gastric Cancer (KLASS-10)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-85
SponsorGangnam Severance Hospital

About this trial

For advanced gastric cancer, surgical resection is the only curable therapeutic strategy. According to minimally invasive approach is adopted in various field of oncologic surgery, laparoscopic gastrectomy with lymph node dissection is becoming a standard not only for early gastric cancer but also for advanced gastric cancer.

The greater omentum is an organ is known to play a role in removing bacteria in the abdominal cavity as a primary defense. Complete resection of the greater omentum has been considered essential to ensure the elimination of micrometastasis during surgery for advanced gastric cancer. However, the oncological effect of total omentectomy is still lack of evidence. Especially in minimal invasive gastrectomy, total omentectomy procedure is known to increases the operating time, increase the risk of bleeding, colonic injury, and postoperative complications such as intra-abdominal abscess, ascites, anastomotic leakage, ileus and wound infections. Therefore, in the case of minimal invasive surgery in early gastric cancer, omentectomy is omitted usually or routinely. Partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Advanced energy devices facilitate partial omentectomy during laparoscopic gastrectomy.

According to the Japanese Gastric Cancer Treatment Guidelines, partial omentectomy (omentum preservation) is feasible for T1 or T2 tumors, and total omentectomy is recommended for clinical T3 or deeper tumors. However, the National Comprehensive Cancer Network(NCCN) guideline suggests total omentectomy and the European Society for Medical Oncology(ESMO) guideline does not mentioned about it.

It is still controversial whether total omentectomy should be performed in advanced gastric cancer. Therefore, we aimed to verify the non-inferiority of partial omentectomy, oncologic safety compared with total omentectomy via multicenter randomized clinical trial.

Eligibility criteria

Qualifiers

Histologically proven adenocarcinoma of the stomach

Age between 20 to 85 years old

ECOG PS 0-1, ASA class I-III

Endoscopically Borrmann type I, II, III

Disqualifiers

Confirmed distant metastasis in preoperative examinations

Confirmed metastasis in abdominal cavity or distant organs during surgery

Confirmed no infiltration of the serosa layer or unable to confirm the tumor location during surgery (sT1-2)

Confirmed invasion of surrounding organs (sT4b)

Trial design

Treatments tested in this trial

  • Arm I (Total omentectomy),
  • Arm II (Partial omentectomy)

Treatment groups

440 Participants
are divided into 2 treatment groups

Sponsors and collaborators