Lung DiseasesNCT05269784
Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol Compared With That With Partially Tubeless Protocol
A study testing Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol and Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol in people with Lung Diseases and ERAS, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
Previous studies have shown the feasibility of ERAS on minimally invasive lung surgery, but it is unknown whether completely tubeless protocol is safe and better. This study aimed to determine whether completely tubeless protocol is feasible and beneficial for minimally invasive lung surgery, compared with partially… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Diseases, ERAS, Surgery
- What is being tested?
- Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol and Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Jul 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wedge resection or sub-lobar resection or lobectomy is considered as the primary surgical strategy. The operation ideally should not exceed 2 hours; (II) No absolute age limit; (III) Patients with Eastern Cooperative Oncology Group (ECOG) physical performance score of ≤2 points; (IV) P a t i e n t s w i t h a n A m e r i c a n S o c i e t y o f Anesthesiologists Standard (ASA) grade of ≤ III; (V) Body mass index (BMI) <30 kg/m2; (VI) Patients with no clinically significant cardiac history, such as ischaemic heart disease, valvular heart disease, rhythm disturbances such as frequent atrial fibrillation or premature ventricular contractions (PVCs). Patients with significant cardiac history should be optimized according the relevant guidelines before surgery is considered; (VII) Normal cardiopulmonary function [predicted forced expiratory volume in the first second (FEV1%) >50% and ejection fraction (EF) >50% of predicted value]. Resting blood gas analysis showing arterial partial pressure of oxygen (PaO2)≥75 mmHg and arterial partial pressure of carbon dioxide (PaCO2) <45 mmHg; (VIII) Normal renal function and no history of urological problems.
Who cannot join
- Patient-related factors: (i) Patients who refuse surgery and/or the anesthesia protocols; (ii) Coagulopathy, hypoxemia (PaO2 <60 mmHg), hypercapnia [arterial carbon dioxide tension (PaCO2) >50 mmHg], or elevated risk of regurgitation (<6 hours of fasting) preoperatively or combined with gastroesophageal reflux disease; neurological disorders; (iii) Severe acute pulmonary infection or tuberculosis; (iv) Relative contraindications: upper airway secretions or persistent cough, spinal deformity, or brain edema (if thoracic epidural anesthesia is to be used); (v) History of ipsilateral surgery and other conditions which can result in extensive pleural adhesion; (vi) Phrenic nerve paralysis on the non-operated side should be viewed as a contraindication to VATS; (vii) History of urological conditions increasing the need for urinary catheterization; (viii) Significant cardiac history. (II) Anesthesia-related factors: (i) Allergy to local anesthesia; (ii) Any contraindication to the regional anesthesia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Yunpeng Zhao, doctor, +8618766188692
About this study
Previous studies have shown the feasibility of ERAS on minimally invasive lung surgery, but it is unknown whether completely tubeless protocol is safe and better. This study aimed to determine whether completely tubeless protocol is feasible and beneficial for minimally invasive lung surgery, compared with partially tubeless protocol.
- Conditions
- Lung Diseases, ERAS, Surgery
- Being tested
- Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol, Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol
- Keywords
- tubeless, enhanced recovery after surgery (ERAS), lung surgery, no intubation, urinary catheter
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless ProtocolProcedure or surgery
Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol
Minimally Invasive Lung Surgery Under ERAS With partially Tubeless ProtocolProcedure or surgery
Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol
| Study group | Role | What they receive |
|---|---|---|
| Completely Tubeless Group | Experimental | minimally invasive lung surgery under ERAS with completely tubeless protocol: no intubation, no urinary catheter, move the chest drainage as fast as possible according the ERAS guideline on the premise of safety. Receives: Procedure: Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol |
| Partially Tubeless Group | Active comparator | minimally invasive lung surgery under ERAS with partially tubeless protocol. Receives: Procedure: Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary irritation and urinary tract infection
incidence rate
Measured: within a week after surgery
0-degree discomfort
proportion
Measured: within 3 days after surgery
duration of postoperative hospital stay
days
Measured: within 7 days after surgery
pneumonia
incidence rate
Measured: within 7 days after surgery
operation time
minutes
Measured: within 150 minutes
bleeding volume
ml ml
Measured: during surgery
volume of drainage
ml
Measured: within 7 days after surgery
Pain degree
On a scale of 1 to 10
Measured: within 7 days after surgery
drainage duration time
days
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Jul 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269784
- Sponsor's protocol ID
- Completely Tubeless ZYP
- Status last verified
- Feb 2022
- First submitted
- 26 Feb 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao Y, Shan L, Zhang W, Li P, Li N, Zhang H, Peng C, Cong B, Zhao X. Minimally invasive lung surgery with an intraoperative completely or partially tubeless protocol: randomized clinical trial. BJS Open. 2024 Dec 30;9(1):zrae132. doi: 10.1093/bjsopen/zrae132.
PubMed 39924850
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol Compared With That With Partially Tubeless Protocol
- ClinicalTrials.gov ID
- NCT05269784
- Acronym / sponsor ID
- Completely Tubeless ZYP
- Conditions
- Lung Diseases, ERAS, Surgery
- Keywords
- tubeless, enhanced recovery after surgery (ERAS), lung surgery, no intubation, urinary catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have shown the feasibility of ERAS on minimally invasive lung surgery, but it is unknown whether completely tubeless protocol is safe and better. This study aimed to determine whether completely tubeless protocol is feasible and beneficial for minimally invasive lung surgery, compared with partially tubeless protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Completely Tubeless Group | Experimental | Procedure: Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocolminimally invasive lung surgery under ERAS with completely tubeless protocol: no intubation, no urinary catheter, move the chest drainage as fast as possible according the ERAS guideline on the premise of safety. |
| Partially Tubeless Group | Active comparator | Procedure: Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocolminimally invasive lung surgery under ERAS with partially tubeless protocol. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Wedge resection or sub-lobar resection or lobectomy is considered as the primary surgical strategy. The operation ideally should not exceed 2 hours; (II) No absolute age limit; (III) Patients with Eastern Cooperative Oncology Group (ECOG) physical performance score of ≤2 points; (IV) P a t i e n t s w i t h a n A m e r i c a n S o c i e t y o f Anesthesiologists Standard (ASA) grade of ≤ III; (V) Body mass index (BMI) <30 kg/m2; (VI) Patients with no clinically significant cardiac history, such as ischaemic heart disease, valvular heart disease, rhythm disturbances such as frequent atrial fibrillation or premature ventricular contractions (PVCs). Patients with significant cardiac history should be optimized according the relevant guidelines before surgery is considered; (VII) Normal cardiopulmonary function [predicted forced expiratory volume in the first second (FEV1%) >50% and ejection fraction (EF) >50% of predicted value]. Resting blood gas analysis showing arterial partial pressure of oxygen (PaO2)≥75 mmHg and arterial partial pressure of carbon dioxide (PaCO2) <45 mmHg; (VIII) Normal renal function and no history of urological problems.
Key exclusion criteria (1 listed)
- Patient-related factors: (i) Patients who refuse surgery and/or the anesthesia protocols; (ii) Coagulopathy, hypoxemia (PaO2 <60 mmHg), hypercapnia [arterial carbon dioxide tension (PaCO2) >50 mmHg], or elevated risk of regurgitation (<6 hours of fasting) preoperatively or combined with gastroesophageal reflux disease; neurological disorders; (iii) Severe acute pulmonary infection or tuberculosis; (iv) Relative contraindications: upper airway secretions or persistent cough, spinal deformity, or brain edema (if thoracic epidural anesthesia is to be used); (v) History of ipsilateral surgery and other conditions which can result in extensive pleural adhesion; (vi) Phrenic nerve paralysis on the non-operated side should be viewed as a contraindication to VATS; (vii) History of urological conditions increasing the need for urinary catheterization; (viii) Significant cardiac history. (II) Anesthesia-related factors: (i) Allergy to local anesthesia; (ii) Any contraindication to the regional anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless ProtocolMinimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol | Procedure or surgery | Completely Tubeless Group |
| Minimally Invasive Lung Surgery Under ERAS With partially Tubeless ProtocolMinimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol | Procedure or surgery | Partially Tubeless Group |
Primary outcome
urinary irritation and urinary tract infection
Time frame: within a week after surgery
incidence rate
0-degree discomfort
Time frame: within 3 days after surgery
proportion
duration of postoperative hospital stay
Time frame: within 7 days after surgery
days
pneumonia
Time frame: within 7 days after surgery
incidence rate
operation time
Time frame: within 150 minutes
minutes
bleeding volume
Time frame: during surgery
ml ml
volume of drainage
Time frame: within 7 days after surgery
ml
Pain degree
Time frame: within 7 days after surgery
On a scale of 1 to 10
drainage duration time
Time frame: within 7 days after surgery
days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 39924850Zhao Y, Shan L, Zhang W, Li P, Li N, Zhang H, Peng C, Cong B, Zhao X. Minimally invasive lung surgery with an intraoperative completely or partially tubeless protocol: randomized clinical trial. BJS Open. 2024 Dec 30;9(1):zrae132. doi: 10.1093/bjsopen/zrae132.
Related trials for Lung Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol and Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol in people with Lung Diseases and ERAS, run by The Second Hospital of Shandong University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunpeng Zhao (18766188692, zyp_baggio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary irritation and urinary tract infection (time frame: within a week after surgery). The study lists 9 primary outcomes in all. 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 NCT05269784, which also lists 1 linked publication.
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 16 Nov 2022.