Neoplasms

Digestive System Diseases

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Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

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

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.

Laparoscopic completion total gastrectomy with D2 lymphadenectomy

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

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

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.

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

The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer: A Prospective Trial (FUGES-004)

The early postoperative complication are defined as the event observed within 30 days after surgery.

Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type

The early mortality are defined as the event observed within 30 days after surgery.

Combined organ resection performing by severe injury or abdominal adhesions

With the number of patients undergoing surgery as the denominator, the number of patients with any of the following intraoperative complications is calculated as numerator.

Including time to first flatus, time to initiation of solid food intake, time to removal of intra-abdominal drains, hospital stay

the values of hemoglobin, prealbumin, albumin, C-reactive protein, and white blood cell count from peripheral blood before the operation and on postoperative day 1, 3, 5 are recorded.

Textbook outcome (TO) was defined based on review of existing TO metrics in the literature including outcomes such as complete-potentially curative status, no intraoperative complications, no eventful postoperative complications (Clavien-Dindo grade III or higher), 15 lymph nodes(LNs) examined, hospital stay \< 21days, no reintervention (surgical, endoscopic or radiological) within 30 days after surgery, no readmission to the intensive care unit (ICU) within 30 days after surgery, no postoperative mortality within 30 days after surgery, and no hospital readmission within 30 days after discharge. When all nine desired health outcomes were realized, TO was achieved.

Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.

Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer	NCT02792881	Remnant Gastric...	Laparoscopic co...	18 Years - 75 Years	Fujian Medical University
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer	NCT02792881	Remnant Gastric...	Laparoscopic co...	18 Years - 75 Years	Fujian Medical University
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer	NCT02792881	Remnant Gastric...	Laparoscopic co...	18 Years - 75 Years	Fujian Medical University
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer	NCT02792881	Remnant Gastric...	Laparoscopic co...	18 Years - 75 Years	Fujian Medical University

Spots Global Cancer Trial Database for laparoscopic completion total gastrectomy with d2 lymphadenectomy