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

Primary Purpose

Remnant Gastric Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic completion total gastrectomy with D2 lymphadenectomy
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Remnant Gastric Cancer focused on measuring Laparoscopic Completion Total Gastrectomy, Remnant gastric cancer, Feasibility, Prognosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age from 18 to 75 years
  • Carcinoma in the remnant stomach encompasses all carcinomas arising in the remnant stomach following a gastrectomy, irrespective of the histology of the primary lesion (benign or malignant) or its risk of recurrence, the extent of resection, or method of reconstruction.
  • cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  • American Society of Anesthesiology score (ASA) class I, II, or III
  • Written informed consent

Exclusion Criteria:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
  • Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  • History of other malignant disease within past five years
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of predicted values

Sites / Locations

  • Fujian Medical University Union Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laparoscopic Completion Total Gastrectomy Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

3-year disease free survival rate
3-year overall survival rate
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
Mortality
The early mortality are defined as the event observed within 30 days after surgery.
Rates of combined organ resection
Combined organ resection performing by severe injury or abdominal adhesions
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.
Number of retrieved lymph nodes
Number of retrieved lymph nodes
Operation time
From skin incision to skin closure
Postoperative recovery course
Including time to first flatus, time to initiation of solid food intake, time to removal of intra-abdominal drains, hospital stay
Intraoperative blood loss
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.
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.
Technical performance
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)
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.

Full Information

First Posted
May 26, 2016
Last Updated
September 19, 2023
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02792881
Brief Title
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer
Official Title
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer: A Prospective Trial (FUGES-004)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remnant Gastric Cancer
Keywords
Laparoscopic Completion Total Gastrectomy, Remnant gastric cancer, Feasibility, Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Completion Total Gastrectomy Group
Arm Type
Experimental
Arm Description
Patients who underwent laparoscopic completion total gastrectomy with D2 lymphadenectomy will be assigned to this group.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic completion total gastrectomy with D2 lymphadenectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morbidity
Description
The early postoperative complication are defined as the event observed within 30 days after surgery.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
3-year disease free survival rate
Time Frame
36 months
Title
3-year overall survival rate
Time Frame
36 months
Title
3-year recurrence pattern
Description
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Time Frame
36 months
Title
Mortality
Description
The early mortality are defined as the event observed within 30 days after surgery.
Time Frame
30days
Title
Rates of combined organ resection
Description
Combined organ resection performing by severe injury or abdominal adhesions
Time Frame
1 day
Title
Intraoperative morbidity rates
Description
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.
Time Frame
1 day
Title
Number of retrieved lymph nodes
Description
Number of retrieved lymph nodes
Time Frame
1 day
Title
Operation time
Description
From skin incision to skin closure
Time Frame
1 day
Title
Postoperative recovery course
Description
Including time to first flatus, time to initiation of solid food intake, time to removal of intra-abdominal drains, hospital stay
Time Frame
10 days
Title
Intraoperative blood loss
Time Frame
1 day
Title
Inflammatory and immune response and nutrional status
Description
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.
Time Frame
7 days
Title
Textbook Outcome
Description
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.
Time Frame
30 days
Title
Technical performance
Description
Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.
Time Frame
1 day
Title
The Surgery Task Load Index (SURG-TLX)
Description
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changming Huang, M.D.,Ph.D.
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China

12. IPD Sharing Statement

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

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