The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer

NCT ID: NCT02792881

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2023-09-30

Brief Summary

This study aims to investigate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.

Detailed Description

In 2005, since Yamada reported the first case of laparoscopic completion total gastrectomy (LCTG) for RGC, laparoscopic technology was widely used in the treatment of RGC. However, due to the low incidence and rapid aggravation of RGC, adhesion, anatomic changes, and more complex lymphatic pathways caused by the previous operation, the popularity of LCTG is limited. Therefore, higher level evidence is warranted to further confirm the safety, feasibility, and oncological outcomes of LCTG in patients with RGC. This prospective single-arm study is designed to evaluate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.

Conditions

Remnant Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic Completion Total Gastrectomy Group

Patients who underwent laparoscopic completion total gastrectomy with D2 lymphadenectomy will be assigned to this group.

Group Type: EXPERIMENTAL

Laparoscopic completion total gastrectomy with D2 lymphadenectomy

Intervention Type: PROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic completion total gastrectomy with D2 lymphadenectomy will be performed with curative treated intent. For carcinomas arising in the remnant stomach with a gastrojejunostomy, jejunal lymph nodes adjacent to the anastomosis are included as regional lymph nodes. The type of reconstruction will be selected according to the surgeon's experience and the anastomotic procedure will be performed extracorporeally through an auxiliary incision.

Interventions

Laparoscopic completion total gastrectomy with D2 lymphadenectomy

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic completion total gastrectomy with D2 lymphadenectomy will be performed with curative treated intent. For carcinomas arising in the remnant stomach with a gastrojejunostomy, jejunal lymph nodes adjacent to the anastomosis are included as regional lymph nodes. The type of reconstruction will be selected according to the surgeon's experience and the anastomotic procedure will be performed extracorporeally through an auxiliary incision.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Age between 18 and 75 years; Carcinomas arise in the remnant stomach following gastrectomy, irrespective of the histology of the primary lesion (benign or malignant) or its risk of recurrence, the extent of resection, or the method of reconstruction; cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 7th Edition; Performance status of 0 or 1 on ECOG scale; ASA class I, II, or III; Written informed consent.

Exclusion Criteria

Distant metastasis in the preoperative examinations; Previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection); Other malignant diseases (except gastric cancer) within the past 5 years; Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes; Women during breast-feeding or pregnancy; Severe mental disorder; Unstable myocardial infarction, angina, or cerebrovascular accident within the past 6 months; History of continuous systematic administration of corticosteroids within one month; FEV1<50% of predicted values; Requirement of simultaneous surgery for other disease; Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chang-Ming Huang, Prof.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Changming Huang, M.D.,Ph.D.

Role: STUDY_CHAIR

Fujian Medical University Union Hospital

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Countries

China

References

Wu D, Zhong Q, Zhang ZQ, Liu SQ, Qiu TY, Chen JY, Jiang YM, Lin GT, Liu ZY, Shang-Guan ZX, Sun YQ, Zheng CH, Li P, Xie JW, Lin JX, Chen QY, Huang CM. Comprehensive comparison of technical performance, surgical outcomes, and oncologic prognosis between remnant gastric cancer and primary upper-third gastric cancer in the era of minimally invasive surgery: A pooled analysis of 3 prospective trials. Surgery. 2025 Jul;183:109395. doi: 10.1016/j.surg.2025.109395. Epub 2025 May 8.

Reference Type: DERIVED

PMID: 40344992 (View on PubMed)

Zhong Q, Wu D, Jiang YM, He QL, Dang XY, Xu DB, Sun YQ, Su GQ, Guo KQ, Cai LS, Zhang HX, Ye W, Lin GT, Li P, Xie JW, Chen QY, Zheng CH, Lu J, Huang CM, Lin JX. The safety, feasibility, and oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer: a prospective study with 3-year follow-up (FUGES-004 study). Int J Surg. 2024 Jun 1;110(6):3382-3391. doi: 10.1097/JS9.0000000000001388.

Reference Type: DERIVED

PMID: 38597388 (View on PubMed)

Other Identifiers

FUGES-004

Identifier Type: -

Identifier Source: org_study_id