Laparoscopic Gastric Function Preserving Surgery Combined With Resection of the Anterior Lymphatic Drainage Area

NCT ID: NCT05160753

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 580 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2024-12-31

Brief Summary

Nowadays, while pursuing the eradication of tumor, how to maximize the preservation of normal anatomy and physiological functions of the stomach, reduce the surgical trauma caused by excessive debridement, and improve the quality of life of patients after surgery has become a more important concern in the treatment of early gastric cancer. This prospective multicenter randomized controlled clinical trial was designed to elucidate the oncologic safety of laparoscopic gastric preservation surgery compared to standard laparoscopic gastrectomy. The oncologic safety of laparoscopic gastric preservation surgery with anterior basal dissection (SBD) compared to standard laparoscopic gastrectomy. This trial is an investigator-initiated, multicenter, prospective, randomized, open, parallel-controlled with a non-inferiority design. Patients diagnosed as distal gastric cancer with clinical stage T1N0M0, with a lesion diameter of 3 cm or less were eligible to participate in this study. Patients will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival.

Conditions

Gastric Cancer Stage I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

gastric function preserving surgery combined with resection of the anterior lymphatic drainage area.

1. Steps of sentinel lymph node dissection Indocyanine green (ICG) tracing of anterior lymph nodes. ICG injection: A 4mL volume of double tracer is injected into the submucosa of the four quadrants of the primary tumor by intraoperative gastroscopic method. 0.5 mL was injected at each site, and 15 minutes after gastroscopic tracer injection, the green anterior lymph nodes were carefully dissected and removed from the surgical area and evaluated for lymph node metastasis by parallel intraoperative freezing.

2. Intraoperative and postoperative pathological examination Intraoperative histological examination of lymph nodes collected from the anterior lymph node pool was performed, If all collected anterior lymph nodes are negative, laparoscopic gastric function preserving surgery will be performed. After surgery, anterior lymph nodes that proved to be tumor-free on intraoperative frozen section examination were reevaluated.

Group Type: EXPERIMENTAL

Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area

Intervention Type: PROCEDURE

A 4mL volume of double tracer is injected into the submucosa of the four quadrants of the primary tumor by intraoperative gastroscopic method., and 15 minutes after gastroscopic tracer injection, the green anterior lymph nodes were carefully dissected and removed from the surgical area and evaluated for lymph node metastasis by parallel intraoperative freezing.If all collected anterior lymph nodes are negative, laparoscopic gastric function preserving surgery will be performed.

Patients in the control group will undergo standard laparoscopic gastrectomy

Patients in the control group will undergo standard laparoscopic gastrectomy (laparoscopic distal gastrectomy with simultaneous D1+ lymph node dissection).

Group Type: ACTIVE_COMPARATOR

Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area

Intervention Type: PROCEDURE

A 4mL volume of double tracer is injected into the submucosa of the four quadrants of the primary tumor by intraoperative gastroscopic method., and 15 minutes after gastroscopic tracer injection, the green anterior lymph nodes were carefully dissected and removed from the surgical area and evaluated for lymph node metastasis by parallel intraoperative freezing.If all collected anterior lymph nodes are negative, laparoscopic gastric function preserving surgery will be performed.

Interventions

Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area

A 4mL volume of double tracer is injected into the submucosa of the four quadrants of the primary tumor by intraoperative gastroscopic method., and 15 minutes after gastroscopic tracer injection, the green anterior lymph nodes were carefully dissected and removed from the surgical area and evaluated for lymph node metastasis by parallel intraoperative freezing.If all collected anterior lymph nodes are negative, laparoscopic gastric function preserving surgery will be performed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. single lesion detected by gastroscopy and clearly diagnosed histologically as gastric adenocarcinoma.

2. patients with gastric cancer with clinical stage T1N0M0 (based on the TNM stage of the 8th edition of AJCC) (T-stage assessed by ultrasound gastroscopy and N-stage and M-stage assessed by enhanced CT).

3. tumor length diameter less than 3 cm.

4. the lesion is located in the gastric sinus.

5. patient age greater than 20 years and less than 80 years.

6. ECOG score of 0 or 1.

7. The patient voluntarily participated in this clinical study.

Exclusion Criteria

1. Patients with gastric cancer suitable for endoscopic treatment (differentiated gastric cancer with tumor length diameter less than 2 cm and located within the mucosa).

2. cardiopulmonary dysfunction that cannot tolerate laparotomy.

3. pyloric duct gastric cancer.

4. Previously undergone upper abdominal surgery.

5. other malignant tumors diagnosed within the previous five years.

6. Pregnant women.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongzhou District Hospital

UNKNOWN

Sponsor Role: collaborator

Haimen People's Hospital

UNKNOWN

Sponsor Role: collaborator

Dongtai People's Hospital

UNKNOWN

Sponsor Role: collaborator

Qidong City People's Hospital

UNKNOWN

Sponsor Role: collaborator

Rudong County Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Qinsheng Mao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Affiliated Hospital of Nantong University

Nantong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

QinSheng Mao

Role: CONTACT

ntfymqs@163.com

008651381161122

References

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Reference Type: BACKGROUND

PMID: 12555293 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24019550 (View on PubMed)

Lips DJ, Schutte HW, van der Linden RL, Dassen AE, Voogd AC, Bosscha K. Sentinel lymph node biopsy to direct treatment in gastric cancer. A systematic review of the literature. Eur J Surg Oncol. 2011 Aug;37(8):655-61. doi: 10.1016/j.ejso.2011.05.001. Epub 2011 Jun 1.

Reference Type: BACKGROUND

PMID: 21636243 (View on PubMed)

Takahashi N, Nimura H, Fujita T, Mitsumori N, Shiraishi N, Kitano S, Satodate H, Yanaga K. Laparoscopic sentinel node navigation surgery for early gastric cancer: a prospective multicenter trial. Langenbecks Arch Surg. 2017 Feb;402(1):27-32. doi: 10.1007/s00423-016-1540-y. Epub 2016 Dec 20.

Reference Type: BACKGROUND

PMID: 27999935 (View on PubMed)

Other Identifiers

LGFPS

Identifier Type: -

Identifier Source: org_study_id