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Quality of LifeNCT03393182

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

A study testing TLDG arm and LADG arm in people with Quality of Life and Gastric Cancer, run by Korea University Anam Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Quality of Life, Gastric Cancer, Surgery
What is being tested?
TLDG arm and LADG arm
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
443 participants
Where
1 siteSouth Korea
Study dates
1 Mar 2018to 18 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Anam Hospital

    Seoul, 02841

Other trials in South Korea

About this study

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)

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.

Read the 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.

Being tested
TLDG arm, LADG arm
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TLDG armProcedure or surgery

    After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)

  • LADG armProcedure or surgery

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

Study groups in NCT03393182
Study groupRoleWhat they receive
TLDG armExperimentalTLDG arm(Totally laparoscopic distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy.
Receives: Procedure: TLDG arm
LADG armExperimentalLADG arm(Laparoscopy-assisted distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed through mini-laparotomy
Receives: Procedure: LADG arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Postoperative 30-day

Secondary outcomes (1)

  1. QOL measurement : EORTC QLQ-C30/STO22

    EORTC QLQ-C30/STO22

    Measured: screening(pre op) / Postoperative 30-day,3-month,6-month,12-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2018
  2. Study start1 Mar 2018
  3. Primary completion18 Aug 2021
  4. Study completion18 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
443 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03393182
Sponsor's protocol ID
KLASS07(CKLASS01)
Status last verified
Apr 2022
First submitted
2 Jan 2018
Last updated
13 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhang Y, Li Z, Tian Y, Yu J, Wang J, Lee C, Wang K, He X, Qiao Q, Ji G, Xu Z, Yang L, Xu H, Du X, Su X, Xing J, Niu Z, Zhu L, Yan S, Li Y, Wang J, Li Z, Zhao Y, You J, Jing C, Fan L, Du Y, Zhao G, Song W, Xuan Y, Zang M, Chen J, Park S, Huang H; China-Korea Laparoscopic Gastrointestinal Surgery Study (CKLASS) Cooperative Group. Morbidity and quality of life of totally laparoscopic versus laparoscopy-assisted distal gastrectomy for early gastric cancer: a multi-center prospective randomized controlled trial (CKLASS01). Gastric Cancer. 2025 Jan;28(1):131-144. doi: 10.1007/s10120-024-01561-y. Epub 2024 Nov 5.

    PubMed 39499377

  • Lee HH, Lee CM, Lee MS, Jeong IH, Son MW, Kim CH, Yoo MW, Oh SJ, Son YG, Choi SI, Jung MR, Seo SH, Park SH, Hwang SH, Min JS, Park S. Morbidity and Mortality After Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy to Treat Gastric Cancer: An Interim Report: A Phase III Multicenter, Prospective, Randomized Trial (The KLASS-07 Trial). J Gastric Cancer. 2024 Jul;24(3):257-266. doi: 10.5230/jgc.2024.24.e22.

    PubMed 38960885

  • Park SH, Lee CM, Hur H, Min JS, Ryu SW, Son YG, Chae HD, Jeong O, Jung MR, Choi CI, Song KY, Lee HH, Kim HG, Jee YS, Hwang SH, Lee MS, Kim KH, Seo SH, Jeong IH, Son MW, Kim CH, Yoo MW, Oh SJ, Kim JG, Hwang SH, Choi SI, Yang KS, Huang H, Park S. Totally laparoscopic versus laparoscopy-assisted distal gastrectomy: the KLASS-07: a randomized controlled trial. Int J Surg. 2024 Aug 1;110(8):4810-4820. doi: 10.1097/JS9.0000000000001543.

    PubMed 38716987

  • 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.

    PubMed 30845995

Questions about this trial

What is this clinical trial studying?

A study testing TLDG arm and LADG arm in people with Quality of Life and Gastric Cancer, run by Korea University Anam Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative 30-day morbidity rate (time frame: Postoperative 30-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03393182, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.

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