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

NCT05495217 | Unknown

• 1 other identifier: XJS2021-13
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Gastrectomy; Laparoscopy

Keywords

Laparoscopy-assisted Gastrectomy; Gastric cancer

Outcome Measures

Primary Outcomes (1)

• Operative time

  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 Outcomes (8)

• Blood pressure

  Through study completion, an average of 2 year.

• End-tidal carbon dioxide

  Through study completion, an average of 2 year.

• Heart rate

  Through study completion, an average of 2 year.

• Estimated blood loss

  Through study completion, an average of 2 year.

• Complications

  Through study completion, an average of 2 year.

Study Arms (2)

Gasless Laparoscopy-assisted Gastrectomy

EXPERIMENTAL

Patients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.

Device: Gasless Laparoscopy

Conventional Laparoscopy-assisted Gastrectomy

OTHER

Patients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.

Device: Conventional Laparoscopy

Interventions

Conventional Laparoscopy DEVICE

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.

Also known as: Laparoscopic Surgery

Conventional Laparoscopy-assisted Gastrectomy

Gasless Laparoscopy DEVICE

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.

Also known as: Gasless Laparoscopic Surgery

Gasless Laparoscopy-assisted Gastrectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 and \<75 years old;
• 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 \[por\]);
• Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM);
• 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)
• Preoperative ECOG status score of 0/1;
• Preoperative ASA (American society of anesthesiology) class of I -III;
• Patients signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Xue Yingwei: lead

Study Sites (1)

Harbin University Cancer Hospital

Harbin, Heilongjiang, 150086, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yingwei Xue, doctor

  Harbin Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Gastrointestinal surgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: August 10, 2022
• Study Start: December 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

CN (1)