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Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DPLDG
LDG
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. patients within 18--75 years old;
  2. patients with a preoperative pathological diagnosis of gastric adenocarcinoma;
  3. patients with a clinical tumor stage of T1N1,T2N0 according to the preoperative examinations (gastroscopy, ultrasound gastroscopy and computed tomography);
  4. patients with a plan to undergo laparoscopic distal gastrectomy and obtain R0 surgical results;
  5. patients without severe heart, liver, lung, or kidney dysfunction;
  6. 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.

Exclusion Criteria:

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

Sites / Locations

  • Nanfang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DPLDG arm

LDG arm

Arm Description

Dual-port laparoscopic distal gastrectomy

Laparoscopic distal gastrectomy

Outcomes

Primary Outcome Measures

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.;

Secondary Outcome Measures

5 year overall survival rate
From date of randomization until the date of first documented date of death from any cause, assessed up to 5 years

Full Information

First Posted
July 10, 2022
Last Updated
November 2, 2022
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05494086
Brief Title
Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer
Official Title
Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer: A Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
As a novel minimally invasive technique,laparoscopic surgery has presently become widely accepted as an alternative treatment for malignant diseases. In the treatment of gastric cancers, it has been reported to be an optionalprocedure with the advantages of less invasiveness,less blood loss, faster postoperative recovery and shorter hospital stay, when compared to open surgery. In general, four or five trocars are required in conventional laparoscopic distal gastrectomy (CLDG), and each port results in abdominal injury, which may lead to port site complications, such as wound infection, dehiscence and small bowel herniation. Hence, it remains challenging to determine whether surgical wounds could be minimized during laparoscopic gastric surgery. The development of reduced-port laparoscopic techniques has been largely due to the appearance of multi-channel ports. A conventional trocar port can only be used for inserting a single instrument. With the advancement of laparoscopic devices, a variety of multi-channel ports have been introduced and used in laparoscopic surgeries. At present, multi-channel ports that have been reported include Uni-X devices (Pnavel Systems, Brooklyn, NY, USA), TriPort devices (Advanced Surgical Concepts,Wicklow, Ireland), SILS devices (Covidien, Norwalk, CT, USA), OctoPort devices (DalimSurgNet, Seoul, Korea) and self-made multichannel devices from medical centers globally. The number of ports located on these multichannel devices varies from two to four. Twoport and three-port devices are more commonly used at present in laparoscopic gastric cancer surgery. In recent years, the use of reduced-port laparoscopic gastrectomy has rapidly increased. Several studies have suggested that, in contrast to conventional laparoscopic gastrectomy (CLG), the reduced-port method has some apparent postoperative benefits in the treatment of gastric cancers, such as shorter hospital stay, less pain, less blood loss and better cosmetic results. Among these studies, most have been about distal gastrectomy. Hence, the application of this technique in total gastrectomy is at present relatively less. As a type of reduced-port technique, Kawamura et al. first used this technique in 2011 to treat early distal gastric cancers, and suggested that dual-port laparoscopic distal gastrectomy (DPLDG) is superior to conventional approaches from the cosmetic standpoint, and has the potential to become a technically acceptable procedure. However, due to the more limited operating space when compared to CLDG, it has been generally considered that DPLDG is more difficult to perform than CLDG. The difficulty of DPLDG is mainly due to insufficient intraoperative traction and exposure, which makes the principle of triangulation and counteraction in DPLDG less good when compared to those in CLDG. In addition, since merely one additional trocar is located at one side of the abdominal wall, it is difficult for the surgeon to change position with the assistant, when necessary. The application of DPLDG to distal gastric cancer remains controversial, and critical comments have been made regarding it.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
DPLDG group :Reduced Port Laparoscopic Distal Gastrectomy LDG group: Laparoscopic Distal Gastrectomy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DPLDG arm
Arm Type
Experimental
Arm Description
Dual-port laparoscopic distal gastrectomy
Arm Title
LDG arm
Arm Type
Active Comparator
Arm Description
Laparoscopic distal gastrectomy
Intervention Type
Procedure
Intervention Name(s)
DPLDG
Intervention Description
Dual-port laparoscopic distal gastrectomy
Intervention Type
Procedure
Intervention Name(s)
LDG
Intervention Description
Laparoscopic distal gastrectomy
Primary Outcome Measure Information:
Title
Early operative morbidity
Description
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.;
Time Frame
Within 30 days following surgery
Secondary Outcome Measure Information:
Title
5 year overall survival rate
Description
From date of randomization until the date of first documented date of death from any cause, assessed up to 5 years
Time Frame
5 years

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: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinhua Chen, Ph.D
Phone
8615626452302
Email
xinhuachen@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, Ph.D
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tian Lin, Ph.D
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tian Lin, Prof.
Phone
13560035029
Ext
86
Email
lintian108@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All
IPD Sharing Access Criteria
All

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Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer

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