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SegmentectomyNCT03192904

Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy

A study testing Energy Instruments and Stapling Device in people with Segmentectomy, run by Ruijin Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

According to published studies, there are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches, and there has been no definitive conclusion about which… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Segmentectomy
What is being tested?
Energy Instruments and Stapling Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
1 Jun 2017to 9 Jun 2018
Phase
Interventional
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age: 18 to 70 years old; 2. Pulmonary nodules or GGO found in chest CT examination, and conform with indications for segmentectomy mentioned in NCCN guidelines:
  • Poor pulmonary reserve or other major comorbidity that contraindicates lobectomy;
  • Peripheral nodule ≤2 cm with at least one of the following:
  • <!-- -->
  • Pure (Adenocarcinoma in situ) AIS histology;
  • Nodule has ≥50% ground-glass appearance on CT;
  • Radiologic surveillance confirms a long doubling time (≥400 days). 3. Normal in preoperative tests, such as blood routine examination, liver function, renal function, coagulation function, etc.
  • 4. ASA score: Grade I-III. 5. Patients who can coordinate the treatment and research and sign the informed consent.

Who cannot join

  • 1. Patients have history of malignant tumor, or have accepted neoadjuvant chemotherapy and(or) radiotherapy.
  • 2. Patients have comorbidities in cardiovascular, kidney, lung or hematopoietic system, who cannot tolerate the surgery.
  • 3. Psychiatric patients。 4. Patient have history of chest trauma or surgery on ipsilateral chest.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial

According to published studies, there are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches, and there has been no definitive conclusion about which method is better. So the investigators want to conduct a prospective study, trying to figure out this problem.

Read the detailed description

Lung cancer has been one of the most serious life-threatening diseases of human society. It has the highest morbidity and mortality worldwide among all the malignant tumors. Due to the popularization of low-dose CT and other means of examination, more and more patients with lung cancer are detected in the early phase of disease. Anatomical segmentectomy is one of the standard surgical procedures for these small pulmonary nodules or ground glass opacity (GGO), which are clinically highly suspected or puncture confirmed early lung cancer lesions. Dissection of the intersegmental plane in segmentectomy is a difficulty that have puzzled thoracic surgeons for decades because of the complicated anatomic relationship and variations, along with lack of boundary between pulmonary segments. There are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches in segmentectomy, not to mention in robot assisted segmentectomy, and there has been no definitive conclusion about which method is better. So the investigators want to conduct a prospective study, trying to figure out this problem.

The investigators set incidence rate of postoperative complications as their primary endpoint. According to their calculation, a total of 136 patients will be enrolled (each group has 68 patients).

Conditions
Segmentectomy
Being tested
Energy Instruments, Stapling Device
Keywords
Lung cancer, Segmentectomy, Postoperative Complication, Stapling Device, Energy Device
Medical subject headings
Lung Neoplasms, Postoperative Complications

What participants receive

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

  • Energy InstrumentsDevice

    Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.

  • Stapling DeviceDevice

    Stapling Device, including linear stapler and curved stapler.

Study groups in NCT03192904
Study groupRoleWhat they receive
Energy Instruments GroupExperimentalAll enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Receives: Device: Energy Instruments
Stapling Device GroupExperimentalAll enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Receives: Device: Stapling Device

What is being measured

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

  1. Incidence of Postoperative Complications

    The primary outcome was the incidence of postoperative complications, including air leakage (defined as a rate of air flow >50 mL/min lasting more than 3 days), atelectasis (visible on chest X-rays with complaints), hemorrhage (bloody drainage more than 200 mL for 3 consecutive hours), pulmonary infection (visible on chest X-rays with complaint), and pulmonary embolism (confirmed by CT scan).

    Measured: postoperative in-hospital stay up to 30 days

Secondary outcomes (14)

  1. Incidence Rates of Each Postoperative Complications

    Measured: postoperative in-hospital stay up to 30 days

  2. Preoperative Lung Function

    Measured: Baseline.

  3. Postoperative Lung Function at the 3rd Month After Surgery

    Measured: at the 3rd month after surgery

  4. Postoperative Hospital Stay

    Measured: up to 24 weeks

  5. Postoperative ICU Stay

    Measured: up to 24 weeks

  6. Duration of Drainage

    Measured: up to 4 weeks

  7. Mortality in 30 Days After Surgery

    Measured: postoperative in-hospital stay up to 30 days

  8. Drainage Volume of the First Day After Surgery

    The duration of chest drainage was different, so we analyzed the drainage volume the first day after surgery of each patient.

    Measured: First day after surgery

  9. Daily Air Leakage Volume

    Measured: During drainage time, up to 4 weeks

  10. Duration of Surgery

    Measured: During surgery

  11. Blood Loss During Surgery

    Measured: During surgery

  12. Number of Conversions

    Proportion of converting to thoracotomy。

    Measured: During surgery

  13. Participants With Malignant Tumors

    Measured: 2 weeks after surgery

  14. Medical Costs

    Measured: During hospital stay, up to 24 weeks

Timeline

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

  1. First posted20 Jun 2017
  2. Study start1 Jun 2017
  3. Primary completion9 Mar 2018
  4. Study completion9 Jun 2018

Why it stopped: One treatment policy showed an advantage at a very high significance level.

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
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03192904
Sponsor's protocol ID
RTS-004
Status last verified
Aug 2021
First submitted
12 Jun 2017
Last updated
31 Aug 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Energy Instruments and Stapling Device in people with Segmentectomy, run by Ruijin Hospital at 1 site in China.

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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 31 Aug 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 China. 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?

Yes. Results are posted in the registry (first posted 13 Jul 2020). 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?

Incidence of Postoperative Complications (time frame: postoperative in-hospital stay up to 30 days). 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 NCT03192904.

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 31 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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