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Gastric CancerPhase 3NCT03196791

Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient

A Phase 3 study testing Sugammadex Sodium in people with Gastric Cancer and Obesity, 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

This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Gastric Cancer, Obesity
What is being tested?
Sugammadex Sodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteSouth Korea
Study dates
10 Oct 2017to 9 Sep 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Gastric cancer patients with laparoscopic subtotal gastrectomy
  • 19-75 years
  • Body mass index(BMI) > 25kg/m2
  • American Society of Anesthesiologists I-III

Who cannot join

  • American Society of Anesthesiologists Class IV
  • End stage renal disease (ESRD) patient
  • Patients with allergy to muscle relaxants
  • Patients with diseases that may affect muscle relaxation

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 Double-blind, Randomized and Controlled Multicenter Prospective Trial to Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient

This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction.

The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons

  • Deep neuromuscular block group (98persons)
  • Moderate neuromuscular group (98persons)
Read the detailed description

This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. This is a randomized controlled trial comparing deep NMB with moderate NMB in laparoscopic subtotal gastrectomy in obese patients with gastric cancer. The design of the study is blinded (the surgical team and the research team are all blinded to the treatment); the attending anesthesiologist is not blinded. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction.

The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons

  • Deep neuromuscular block group (98persons)
  • Moderate neuromuscular group (98persons) The patients are assigned to the deep NMB group or the moderate NMB group. The clinical research coordinator (CRC) uses a computer randomization program to determine the degree of muscle relaxation of each patient. Stratified block randomization is used to guarantee even distribution, which means that all participating hospitals are assigned moderate or deep NMB randomly in a 1:1 ratio. The CRC notifies the anesthesiologist of the degree of muscle relaxation just before the operation. Surgeons are blinded to the degree of muscle relaxation: They can enter the operating room after the muscle relaxation has been performed. A train-of-four (TOF) monitor is placed out of the surgeon's visual field. The anesthesiologist injects sugammadex after confirming the absence of the surgeon. The ward staff members who evaluate patient outcomes are blinded to the degree of muscle relaxation.
Being tested
Sugammadex Sodium
Medical subject headings
Stomach Neoplasms, Obesity

What participants receive

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

  • Sugammadex SodiumDrug

    Also called Bridion®, MSD

    1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.
    2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
Study groups in NCT03196791
Study groupRoleWhat they receive
Deep neuromuscular block groupExperimentalSugammadex sodium 4mg/kg/IV after operation
Receives: Drug: Sugammadex Sodium
Moderate neuromuscular groupExperimentalSugammadex sodium 2mg/kg/IV after operation
Receives: Drug: Sugammadex Sodium

What is being measured

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

  1. Number of Retrieved Lymph Nodes Per Participant

    Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery

    Measured: within 14 days after operation

Secondary outcomes (3)

  1. Surgical Rating Score (SRS)

    Surgical rating score (SRS) at Four anatomical area during LN dissection

    During surgery, the surgeon reported the SRS based on the Leiden surgical rating scale (1=extremely poor, 2=poor, 3=acceptable, 4=good, 5=optimal) for each anatomical landmark (LN stations 4sb, 6, and 5 and the suprapancreatic area).

    Measured: immediately after the operation

  2. Number of Participants With at Least One Interruption Event

    Interrupted event by patient movement, coughing, muscle spasm during operation

    Measured: immediately after surgery

  3. Intraoperative Blood Loss Amount

    Amount of bleeding during operation

    Measured: immediately after the operation

Timeline

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

  1. First posted23 Jun 2017
  2. Study start10 Oct 2017
  3. Primary completion9 Aug 2020
  4. Study completion9 Sep 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03196791
Sponsor's protocol ID
Debloqs_GC
Status last verified
Jun 2021
First submitted
20 Jun 2017
Last updated
12 Jul 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park SH, Huh H, Choi SI, Kim JH, Jang YJ, Park JM, Kwon OK, Jung MR, Jeong O, Lee CM, Min JS, Kim JJ, An L, Yang KS, Park S, Lee IO; Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients (DEBLOQS_GC) Study Group. Impact of the Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients: A Randomized Clinical Trial. J Am Coll Surg. 2022 Mar 1;234(3):326-339. doi: 10.1097/XCS.0000000000000061.

    PubMed 35213496

  • Lee Y, Ha D, An L, Jang YJ, Huh H, Lee CM, Kim YH, Kim JH, Park SH, Mok YJ, Lee IO, Kwon OK, Kwak KH, Min JS, Kim EJ, Choi SI, Yi JW, Jeong O, Jung MR, Bae HB, Park JM, Jung YH, Kim JJ, Kim DA, Park S. Comparison of oncological benefits of deep neuromuscular block in obese patients with gastric cancer (DEBLOQS_GC study): A study protocol for a double-blind, randomized controlled trial. Medicine (Baltimore). 2018 Dec;97(49):e13424. doi: 10.1097/MD.0000000000013424.

    PubMed 30544421

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sugammadex Sodium in people with Gastric Cancer and Obesity, 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 4 inclusion and 4 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 12 Jul 2021. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Retrieved Lymph Nodes Per Participant (time frame: within 14 days after operation). 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 NCT03196791, which also lists 2 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 12 Jul 2021.

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