Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer

NCT05494086 | Recruiting DMC

• 1 other identifier: NFEC-2022-266
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Dual-port laparoscopic gastrectomy (DPLG) has been widely performed in recent years for treating gastric cancers. The present study explore the safety and effect of dual-port laparoscopic distal gastrectomy (DPLDG).

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Early operative morbidity

  Including wound complications (infection, effusion, dehiscence,poor healing), intra-abdominal active bleeding,digestive tract active bleeding, anastomotic leakage, anastomotic stenosis, intestinal fistula, pancreatic fistula, chylous fistula, intra-abdominal abscess formation, gastroparesis, intestinal paralysis, intestinal obstruction, cholecystitis, pancreatitis, pneumonia, pleural effusion, pulmonary embolism, cardiocerebrovascular complications, deep venous thrombosis, urinary tract complications, catheter-related complications, condition of pain,etc.;

  Within 30 days following surgery

Secondary Outcomes (1)

• 5 year overall survival rate

  5 years

Study Arms (2)

DPLDG arm

EXPERIMENTAL

Dual-port laparoscopic distal gastrectomy

Procedure: DPLDG

LDG arm

ACTIVE COMPARATOR

Laparoscopic distal gastrectomy

Procedure: LDG

Interventions

DPLDG PROCEDURE

Dual-port laparoscopic distal gastrectomy

DPLDG arm

LDG PROCEDURE

Laparoscopic distal gastrectomy

LDG arm

Eligibility Criteria

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

You may qualify if:

• patients within 18--75 years old;
• patients with a preoperative pathological diagnosis of gastric adenocarcinoma;
• patients with a clinical tumor stage of T1N1,T2N0 according to the preoperative examinations (gastroscopy, ultrasound gastroscopy and computed tomography);
• patients with a plan to undergo laparoscopic distal gastrectomy and obtain R0 surgical results;
• patients without severe heart, liver, lung, or kidney dysfunction;
• patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1; and (7) patients with American Society of Anesthesiologists (ASA) I-II.

You may not qualify if:

• patients with a history of upperabdominal surgery;
• patients who presentedas an emergency case;
• patients with other histories of malignant diseases within 5 years;
• patients with prior neoadjuvant chemotherapy or radiation therapy; and (5)patients who need simultaneous surgical treatment for other malignant diseases.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Guoxin Li, Ph.D

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

• Tian Lin, Ph.D

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinhua Chen, Ph.D

CONTACT

8615626452302; xinhuachen@163.com

Tian Lin, Ph.D

CONTACT

8613560035029

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: DPLDG group :Reduced Port Laparoscopic Distal Gastrectomy LDG group: Laparoscopic Distal Gastrectomy

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: August 9, 2022
• Study Start: August 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: All

Locations

CN (1)