Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05541783
• Collaborator: (none)
• Enrollment: 202
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Procedure: laparoscopy-assisted distal gastrectomy Group; Procedure: Totally laparoscopic distal gastrectomy	N/A

Detailed Description

Although totally laparoscopic distal gastrectomy (TLDG) and laparoscopic-assisted distal gastrectomy (LADG) are both minimally invasive surgeries for gastric cancer with the same surgical treatment principles, in the former, all surgical processes are performed intracorporeally, while, in the latter, extracorporeal gastro-enteric anastomosis is achieved. Whether the procedural differences between TLDG and LADG affect quality of life （QOL）is still under debate.To evaluate how each laparoscopic surgery affect QOL of patients with gastric cancer, it is necessary to compare the postoperative QOL (scoring by questionnaire) between the patients undergoing TLDG and LADG through a multi-center randomized controlled trial.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 202 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center Prospective Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopic-assisted Distal Gastrectomy (LADG) and Totally Laparoscopic Distal Gastrectomy (TLDG) for Gastric Cancer
• Anticipated Study Start Date: Sep 15, 2022
• Anticipated Primary Completion Date: Sep 15, 2024
• Anticipated Study Completion Date: Sep 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laparoscopy-assisted distal gastrectomy The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction.	Procedure: laparoscopy-assisted distal gastrectomy Group; LADG
Experimental: Totally laparoscopic distal gastrectomy The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy.	Procedure: Totally laparoscopic distal gastrectomy; TLDG

Outcome Measures

Primary Outcome Measures

1. Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire [1 months postoperative]

   Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 1 months postoperative

Secondary Outcome Measures

1. Scores on the other scales of EORTC QLQ-C30 questionnaire postoperative [1 months postoperative]

   Scores on the other scales of EORTC QLQ-C30 questionnaire at 1 months postoperative

2. Scores on EORTC QLQ-C30 questionnaire [7 day and 1 months postoperative]

   Scores on EORTC QLQ-C30 questionnaire at 7 day and 1 months postoperative

3. Usage of analgesics [1-7 day postoperative]

   Usage of analgesics postoperatively

4. Length of stay [1 months postoperative]

   Length of stay

5. Scores on the other scales of ST22 questionnaire postoperative [1 months postoperative]

   Scores on the other scales of ST22 questionnaire at 1 months postoperative

6. Scores on ST22 questionnaire [7 day and 1 months postoperative]

   Scores on ST22 questionnaire at 7 day and 1 months postoperative

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)

• age between 20 and 80 years old

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)

• scheduled for laparoscopic distal gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese

• written informed consent

• tumor size<5cm preoperatively

Exclusion Criteria:

• clinical stage T1-4N0-3M1 according to the 8th edition of the Americal Joint Committee on Cancer System

• history of chemotherapy, radiotherapy, immunotherapy or target therapy

• perigastric lymphnode≥3cm

• received gastric surgery (i.e. gastrectomy or gastrojejunostomy)

• multiple primary tumors

• suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.

• patients need emergency operation with complication of gastric cancer

• adhesion due to the previous intraabdominal surgery

• need for combined organ resection due to aggression of gastric cancer of other disease,

• vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)

• currently participating or participated in other clinical trials in the last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: Dazhi Xu, PHD, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dazhi Xu, PHD,MD, Fudan University
• ClinicalTrials.gov Identifier: NCT05541783
• Other Study ID Numbers: LATDG
• First Posted: Sep 15, 2022
• Last Update Posted: Sep 15, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dazhi Xu, PHD,MD, Fudan University: Gastric cancer，Laparoscopic distal gastrectomy
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Sep 15, 2022