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

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

Detailed Description
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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.

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

Conditions
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Remnant Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopic completion total gastrectomy with D2 lymphadenectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Completion Total Gastrectomy Group<br>Patients who underwent laparoscopic completion total gastrectomy with D2 lymphadenectomy will be assigned to this group. | Procedure: Laparoscopic completion total gastrectomy with D2 lymphadenectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | The early postoperative complication are defined as the event observed within 30 days after surgery. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate |  | 36 months | 
| 3-year overall survival rate |  | 36 months | 
| 3-year recurrence pattern | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type | 36 months | 
| Mortality | The early mortality are defined as the event observed within 30 days after surgery. | 30days | 
| Rates of combined organ resection | Combined organ resection performing by severe injury or abdominal adhesions | 1 day | 
| Intraoperative morbidity rates | 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. | 1 day | 
| Number of retrieved lymph nodes | Number of retrieved lymph nodes | 1 day | 
| Operation time | From skin incision to skin closure | 1 day | 
| Postoperative recovery course | Including time to first flatus, time to initiation of solid food intake, time to removal of intra-abdominal drains, hospital stay | 10 days | 
| Intraoperative blood loss |  | 1 day | 
| Inflammatory and immune response and nutrional status | 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. | 7 days | 
| Textbook Outcome | 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. | 30 days | 
| Technical performance | Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool. | 1 day | 
| The Surgery Task Load Index (SURG-TLX) | Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Completion Total Gastrectomy, Remnant gastric cancer, Feasibility, Prognosis