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

NCT06608381 | Recruiting Phase 3

• 1 other identifier: 3-2023-0385
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year relapse free survival

  Verify the non-inferiority of partial omentectomy(omentum preservation) in 3-year relapse free survival(RFS). Kaplan-Meier and log-rank tests will be used.

  3 year after surgery

Secondary Outcomes (5)

• 3-year overall survival

  3 year after surgery

• Estimated blood loss

  during surgery

• Operation time

  during surgery

• Post-operative complications (Early, and delayed complication)

  1 month after surgery & 3 year after surgery ( Evaluate 2 times to analyze early complication, and delayed complication respectively)

• Post-operative mortality

  3 months after surgery

Study Arms (2)

Total omentectomy group

ACTIVE COMPARATOR

During minimally invasive radical gastrectomy and D2 lymph node dissection, total omentectomy will be performed.

Procedure: Arm I (Total omentectomy),

Partial omentectomy group

EXPERIMENTAL

During minimally invasive radical gastrectomy and D2 lymph node dissection, partial omentectomy will be performed.

Procedure: Arm II (Partial omentectomy)

Interventions

Arm I (Total omentectomy), PROCEDURE

The surgery is performed with minimal invasive surgery, and the range of the surgery is radical gastrectomy and D2 lymph node dissection. Depending on the random assignment, total omentectomy and partial omentectomy (omentum preservation) will be performed for the control group and the experimental group, respectively. Total omentectomy removes whole greater omentum, while partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Other surgical procedures are the same as usual in both groups.

Total omentectomy group

Arm II (Partial omentectomy) PROCEDURE

The surgery is performed with minimal invasive surgery, and the range of the surgery is radical gastrectomy and D2 lymph node dissection. Depending on the random assignment, total omentectomy and partial omentectomy (omentum preservation) will be performed for the control group and the experimental group, respectively. Total omentectomy removes whole greater omentum, while partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Other surgical procedures are the same as usual in both groups.

Partial omentectomy group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Clinical T3 and T4a tumors with or without regional lymph node metastases (cT3N0M0\~T4aN3M0)
• Capable of minimal invasive radical subtotal gastrectomy with R0 resection in preoperative examinations
• Patients who signed an written consent form approved by the Institutional Review Board(IRB) after receiving sufficient explanations of the contents of the clinical trial
• Domestic patients who are able to follow up for 3 years after surgery

You may not qualify if:

• 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)
• History of previous gastrectomy or greater omentum related surgery
• Patients who underwent preoperative treatment (chemotherapy, radiotherapy, or endoscopic submucosal dissection) for recently diagnosed gastric cancer
• Synchronous or metachronous malignancies, which underwent surgery, chemotherapy or radiotherapy within 5 years
• Patients judged to be inappropriate for the study by the physician. (ex. Pregnancy)
• Patients refused to participate after random assignment
• Surgery is not performed until 30 days after consenting to participate
• Patients who has participated in another on-going clinical trial, which is related surgical procedures and survival.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Random group assignment during operation * Control group : Total omentectomy * Experimental group : Partial omentectomy Other surgical procedures are the same as usual in both groups.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)