Comparing the Quality of Life Between LADG and TLDG for Gastric Cancer_KLASS07 (CKLASS01)).

April 12, 2022 updated by: Sungsoo Park, Korea University Anam Hospital

A Multicenter Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopy-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric cancer_KLASS 07 (CKLASS01)(Korea-China Collaborated Study)

The present randomized study is designed to compare the quality of life between the patients undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy to laparoscopy-assisted distal gastrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary endpoint of this trial is the early postoperative morbidity, that is defined as complications that occur within 30 days after surgery.

Early postoperative morbidity is classified as follows:

(1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3) lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7) postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others: lymphorrhea, diarrhea, etc.

The secondary end point is the questionnaire score regarding QOL. This is assessed by the Korean versions of the EORTC QLQ-C30 (version 3.0) and STO22 questionnaires.

Study Type

Interventional

Enrollment (Actual)

443

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

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
  • Age between 20 and 80 years old
  • Eastern Cooperative Oncology Group performance statu of 0 or 1
  • Clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the American Joint Committee on Cancer system10 (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
  • Scheduled for laparoscopic distal gastrectomy with D1+ or D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2010 (ver.3).)
  • Patients who gave a consent and signed the formal paper permitted by Institutional Review Board (IRB) after hearing a full description of the study (purpose and contents) prior to the participation

Exclusion Criteria:

  • Patients who received stomach surgery (i.e. gastrectomy or gastrojejunostomy) in the past
  • Patients with intraabdominal adhesion due to previous intraperitoneal surgery
  • Patients who recently diagnosed with gastric cancer and received either anticancer treatment or radiation therapy
  • Patients who requires combined organ resection due to aggression of gastric cancer or other diseases
  • Patients who received surgeries due to primary cancer of other organs, or had anticancer treatment or radiation therapy in the last five years (patients whose skin basal cell carcinoma and insitu cervical cancer are completely cured are exceptions).
  • Vulnerable people who can't communicate or are pregnant (or planning to be pregnant)
  • Patients who are currently participating or participated in other clinical trials in the last six months.

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: TLDG arm

TLDG arm(Totally laparoscopic distal gastrectomy)

: After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy.
Procedure: TLDG arm
After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)
Experimental: LADG arm

LADG arm(Laparoscopy-assisted distal gastrectomy)

: After lymphadenectomy, gastrectomy and reconstruction procedure are performed through mini-laparotomy
Procedure: LADG arm
After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative 30-day morbidity rate
Time Frame: Postoperative 30-day

Check the morbidity rate

:Wound, seroma, hematoma, wound infection, wound dehiscence, wound evisceration, Fluid collection/Abscess, Intraabdominal bleeding, Intraluminal bleeding, Postoperative ileus, Anastomosis stenosis, Anastomosis leakage, Pancreatitis or pancreatic fistula, Complication(Pulmonary, Urinary, Renal, Hepatic, Cardiac, Endocrine) etc.
Postoperative 30-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QOL measurement : EORTC QLQ-C30/STO22
Time Frame: screening(pre op) / Postoperative 30-day,3-month,6-month,12-month
EORTC QLQ-C30/STO22
screening(pre op) / Postoperative 30-day,3-month,6-month,12-month

Collaborators and Investigators

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

Sponsor

Korea University Anam Hospital

Collaborators

Shanghai Medical College of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2018

Primary Completion (Actual)

August 18, 2021

Study Completion (Actual)

February 18, 2022

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLASS07(CKLASS01)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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