Lung CancerNCT04451473
Lung Surgery With Enhanced Recovery VS. Lung Surgery Without Enhanced Recovery
A study testing Enhanced Recovery After Surgery (ERAS ) and Traditional perioperative management without Enhanced Recovery After Surgery (ERAS ) in people with Lung Cancer and Surgery, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
Objective: The adoption of Enhanced Recovery Surgery programs in lung resection is relatively recent with limited outcome data. This study aimed to determine the impact of an Enhanced Recovery Surgery pathway on short- term and long- term results in patients undergoing lung resection for primary lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer, Surgery, ERAS
- What is being tested?
- Enhanced Recovery After Surgery (ERAS ) and Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2019to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Inclusion Criteria: patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need VATS surgery.
-
Exclusion Criteria: cardio-pulmonary function couldn't tolerate surgery
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yunpeng Zhao
Jinan, Shandong, 250033
Yunpeng Zhao, Doc., 17660081916 ext. 17660081916, zhaoyunpengsddx@sdu.edu.cn
About this study
Official title: The Short Term and Long Term Comparison of Lung Surgery With or Without Enhanced Recovery
Objective: The adoption of Enhanced Recovery Surgery programs in lung resection is relatively recent with limited outcome data. This study aimed to determine the impact of an Enhanced Recovery Surgery pathway on short- term and long- term results in patients undergoing lung resection for primary lung cancer.
Methods: A Randomized Controlled Trial was designed to collect the perioperative data on consecutive patients undergoing lung resection for primary lung cancer. Patients will be randomizely assigned to the ERAS- Group and Control- Group. Short-term and long- term effect will be compared between the two groups.
- Conditions
- Lung Cancer, Surgery, ERAS
- Being tested
- Enhanced Recovery After Surgery (ERAS ), Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS )Procedure or surgery
the treatment of procedure according to Guidelines for enhanced recovery after lung surgery: recommendations of the ERAS Society and the ESTS
Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )Procedure or surgery
the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery
| Study group | Role | What they receive |
|---|---|---|
| ERAS- Group | Experimental | Patients underwent surgery for lung cancer accepted the enhanced recovery after surgery (ERAS). Receives: Procedure: Enhanced Recovery After Surgery (ERAS ) |
| Control- Group | Other | Patients underwent surgery for lung cancer without enhanced recovery after surgery (ERAS). Receives: Procedure: Traditional perioperative management without Enhanced Recovery After Surgery (ERAS ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensive care unit utilization
the time in intensive care unit utilization
Measured: within 4 days after surgery
the degree of pain
Visual Analogue Scale/Score
Measured: within 4 days after surgery
the time of ambulation
the time after surgery that patients could leave the bed and walk
Measured: within 48 hours after surgery
the time for oral feed
the time for oral feed
Measured: within 48 hours after surgery
the time of hospitalization
the time of hospitalization
Measured: within 5 days after surgery
complications
the rate of complications
Measured: within 7 days after surgery
Secondary outcomes (2)
disease- free survival
disease- free survival
Measured: within 5 years after surgery
overall survival
overall survival
Measured: within 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start8 Oct 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2027 (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 CancerStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaogang Zhao, Doctor, Study director, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451473
- Sponsor's protocol ID
- ERAS ZYP
- Status last verified
- Feb 2022
- First submitted
- 27 Jun 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding Y, Zhou L, Shan L, Zhang W, Li P, Cong B, Tian Z, Zhao Y, Zhao X. Video- assisted thoracoscopic lung resection with or without enhanced recovery after surgery: a single institution, prospective randomized controlled study. Front Oncol. 2024 Nov 8;14:1474438. doi: 10.3389/fonc.2024.1474438. eCollection 2024.
PubMed 39582544
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
- The Short Term and Long Term Comparison of Lung Surgery With or Without Enhanced Recovery
- ClinicalTrials.gov ID
- NCT04451473
- Acronym / sponsor ID
- ERAS ZYP
- Conditions
- Lung Cancer, Surgery, ERAS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jun 2020 (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.
Objective: The adoption of Enhanced Recovery Surgery programs in lung resection is relatively recent with limited outcome data. This study aimed to determine the impact of an Enhanced Recovery Surgery pathway on short- term and long- term results in patients undergoing lung resection for primary lung cancer.
Methods: A Randomized Controlled Trial was designed to collect the perioperative data on consecutive patients undergoing lung resection for primary lung cancer. Patients will be randomizely assigned to the ERAS- Group and Control- Group. Short-term and long- term effect will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS- Group | Experimental | Procedure: Enhanced Recovery After Surgery (ERAS )Patients underwent surgery for lung cancer accepted the enhanced recovery after surgery (ERAS). |
| Control- Group | Other | Procedure: Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )Patients underwent surgery for lung cancer without enhanced recovery after surgery (ERAS). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS )the treatment of procedure according to Guidelines for enhanced recovery after lung surgery: recommendations of the ERAS Society and the ESTS | Procedure or surgery | ERAS- Group |
| Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery | Procedure or surgery | Control- Group |
Primary outcome
intensive care unit utilization
Time frame: within 4 days after surgery
the time in intensive care unit utilization
the degree of pain
Time frame: within 4 days after surgery
Visual Analogue Scale/Score
the time of ambulation
Time frame: within 48 hours after surgery
the time after surgery that patients could leave the bed and walk
the time for oral feed
Time frame: within 48 hours after surgery
the time for oral feed
the time of hospitalization
Time frame: within 5 days after surgery
the time of hospitalization
complications
Time frame: within 7 days after surgery
the rate of complications
2 secondary outcomes
disease- free survival
Time frame: within 5 years after surgery
overall survival
Time frame: within 10 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 39582544Ding Y, Zhou L, Shan L, Zhang W, Li P, Cong B, Tian Z, Zhao Y, Zhao X. Video- assisted thoracoscopic lung resection with or without enhanced recovery after surgery: a single institution, prospective randomized controlled study. Front Oncol. 2024 Nov 8;14:1474438. doi: 10.3389/fonc.2024.1474438. eCollection 2024.
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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.
Xiaogang Zhao, Doctor study director
The Second Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery (ERAS ) and Traditional perioperative management without Enhanced Recovery After Surgery (ERAS ) in people with Lung Cancer and Surgery, 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?
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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunpeng Zhao, Doctor (17660081916 ext. 17660081916, zhaoyunpengsddx@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensive care unit utilization (time frame: within 4 days after surgery). The study lists 6 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 NCT04451473, 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.