A Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer

August 8, 2022 updated by: Xue Yingwei

A Single-center, Randomized, Controlled Clinical Study for Comparison of the Effects Between Gasless Laparoscopy-assisted and Conventional Laparoscopy-assisted Gastrectomy With D2 Lymphadenectomy for Distal Gastric Cancer

The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary end point was operative time for Gasless laparoscopy-assisted distal D2 radical gastrectomy and conventional laparoscopy-assisted distal D2 radical gastrectomy. The secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for D2 radical gastrectomy.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • Harbin University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age >18 and <75 years old;
  2. The gastric primary lesion is diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathologic techniques (papillary adenocarcinoma [pap], tubular adenocarcinoma [tub], mucinous adenocarcinoma [muc], signet ring cell carcinoma [sig], and poorly differentiated adenocarcinoma [por]);
  3. Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM);
  4. It is expected that R0 surgical results will be obtained by distal subtotal gastrectomy and D2 lymph node dissection (also applies to multiple primary tumors)
  5. Preoperative ECOG status score of 0/1;
  6. Preoperative ASA (American society of anesthesiology) class of I -III;
  7. Patients signed informed consent.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Serious mental illness;
  3. History of abdominal surgery (except for laparoscopic cholecystectomy);
  4. History of gastric surgery (including ESD/EMR for gastric cancer);
  5. Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm)
  6. Other malignant disease history within five (5) years;
  7. Patients who received or were recommended a new adjuvant therapy;
  8. History of unstable angina or myocardial infarction within six (6) months;
  9. History of cerebral infarction or cerebral hemorrhage within six (6) months;
  10. History of sustained systemic corticosteroid therapy within one (1) month;
  11. Patients requiring simultaneous surgical treatment of other diseases;
  12. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery;
  13. Pulmonary function test with FEV1 <50% of the expected value.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gasless Laparoscopy-assisted Gastrectomy
Patients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.
Device: Gasless Laparoscopy
A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY without Induced pneumoperitoneum.It mechanically elevates the abdominal wall and allows laparoscopic visualization through a single incision, providing diagnostic and therapeutic procedures.
Other Names:
  • Gasless Laparoscopic Surgery
Other: Conventional Laparoscopy-assisted Gastrectomy
Patients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.
Device: Conventional Laparoscopy
A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY using Induced pneumoperitoneum.
Other Names:
  • Laparoscopic Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: During procedure.
The primary end point was operative time for Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy and conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy.
During procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: Through study completion, an average of 2 year.
Intraoperative blood pressure
Through study completion, an average of 2 year.
End-tidal carbon dioxide
Time Frame: Through study completion, an average of 2 year.
Intraoperative end-tidal carbon dioxide
Through study completion, an average of 2 year.
Heart rate
Time Frame: Through study completion, an average of 2 year.
Intraoperative heart rate
Through study completion, an average of 2 year.
Estimated blood loss
Time Frame: Through study completion, an average of 2 year.
Intraoperative estimated blood loss
Through study completion, an average of 2 year.
Complications
Time Frame: Through study completion, an average of 2 year.
Intraoperative complications
Through study completion, an average of 2 year.
Death
Time Frame: Through study completion, an average of 2 year.
Intraoperative death
Through study completion, an average of 2 year.
Blood transfusion
Time Frame: Through study completion, an average of 2 year.
Intraoperative and postoperative blood transfusion
Through study completion, an average of 2 year.
Tumor size
Time Frame: Through study completion, an average of 2 year.
Tumor size
Through study completion, an average of 2 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xue Yingwei

Investigators

  • Study Director: Yingwei Xue, doctor, Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 23, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJS2021-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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