Remnant Gastric Cancer
Conditions
Keywords
Laparoscopic Completion Total Gastrectomy, Remnant gastric cancer, Feasibility, Prognosis
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.
Interventions
PROCEDURELaparoscopic 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.
Sponsors
Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 30 days | The early postoperative complication are defined as the event observed within 30 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate | 36 months | — |
| 3-year overall survival rate | 36 months | — |
| 3-year recurrence pattern | 36 months | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type |
| Mortality | 30days | The early mortality are defined as the event observed within 30 days after surgery. |
| Rates of combined organ resection | 1 day | Combined organ resection performing by severe injury or abdominal adhesions |
| Intraoperative morbidity rates | 1 day | 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. |
| Postoperative recovery course | 10 days | Including time to first flatus, time to initiation of solid food intake, time to removal of intra-abdominal drains, hospital stay |
| Operation time | 1 day | From skin incision to skin closure |
| Intraoperative blood loss | 1 day | — |
| Inflammatory and immune response and nutrional status | 7 days | 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 | 30 days | 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 | 1 day | Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool. |
| The Surgery Task Load Index (SURG-TLX) | 1 day | Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure. |
| Number of retrieved lymph nodes | 1 day | Number of retrieved lymph nodes |
Countries
China
Outcome results
None listed