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

Primary Purpose

Quality of Life, Gastric Cancer, Surgery

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TLDG arm
LADG arm
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TLDG arm

LADG arm

Arm Description

TLDG arm(Totally laparoscopic distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy.

LADG arm(Laparoscopy-assisted distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed through mini-laparotomy

Outcomes

Primary Outcome Measures

Postoperative 30-day morbidity rate
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.

Secondary Outcome Measures

QOL measurement : EORTC QLQ-C30/STO22
EORTC QLQ-C30/STO22

Full Information

First Posted
January 2, 2018
Last Updated
April 12, 2022
Sponsor
Korea University Anam Hospital
Collaborators
Shanghai Medical College of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03393182
Brief Title
Comparing the Quality of Life Between LADG and TLDG for Gastric Cancer_KLASS07 (CKLASS01)).
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
August 18, 2021 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital
Collaborators
Shanghai Medical College of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Gastric Cancer, Surgery, Surgical Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, multi-center trial that comparing surgical complications and Quality of Life between "Totally laparoscopic distal gastrectomy" and "Laparoscopy-assisted distal gastrectomy" in Korea.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TLDG arm
Arm Type
Experimental
Arm Description
TLDG arm(Totally laparoscopic distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy.
Arm Title
LADG arm
Arm Type
Experimental
Arm Description
LADG arm(Laparoscopy-assisted distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed through mini-laparotomy
Intervention Type
Procedure
Intervention Name(s)
TLDG arm
Intervention Description
After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)
Intervention Type
Procedure
Intervention Name(s)
LADG arm
Intervention Description
After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)
Primary Outcome Measure Information:
Title
Postoperative 30-day morbidity rate
Description
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.
Time Frame
Postoperative 30-day
Secondary Outcome Measure Information:
Title
QOL measurement : EORTC QLQ-C30/STO22
Description
EORTC QLQ-C30/STO22
Time Frame
screening(pre op) / Postoperative 30-day,3-month,6-month,12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30845995
Citation
Lee CM, Park JH, In Choi C, Lee HH, Min JS, Jee YS, Jeong O, Chae H, Choi SI, Huang H, Park S. A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol). BMC Cancer. 2019 Mar 7;19(1):206. doi: 10.1186/s12885-019-5396-8.
Results Reference
derived

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

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