Esophageal CancerNCT07004634
Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE）
A study testing Chest mediastinal tube, Abdominal mediastinal tube and Chest tube + chest mediastinal tube in people with Esophageal Cancer and Drainage/Methods, run by Ruijin Hospital at 1 site in China.
Trial summary
This RCT compares three drainage approaches after minimally invasive esophagectomy (chest tube + thoracic mediastinal drainage tube, thoracic, and abdominal mediastinal drainage tube) to evaluate perioperative outcomes, addressing current evidence gaps in pain and complication profiles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Drainage/Methods, Postoperative Pain
- What is being tested?
- Chest mediastinal tube, Abdominal mediastinal tube and Chest tube + chest mediastinal tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 1 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Pathologically confirmed esophageal cancer requiring three-incision esophagectomy (cervical, thoracic, and abdominal incisions)
- ASA physical status class I-III
Who cannot join
- History of chronic pain or long-term use of analgesics prior to surgery
- Severe cardiopulmonary dysfunction (e.g., FEV1 <50%)
- Coagulation disorders or patients undergoing reoperation
- Intraoperative findings of extensive pleural adhesions, combined resection of adjacent organs, or other conditions deemed by the investigator to warrant exclusion
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
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Dingpei Han, PhD, MD, 00862164370045 ext. 666112, dmhan1985@163.com
About this study
Official title: Comparison of the Application Effects of Different Drainage Modes in the Perioperative Period of Minimally Invasive Three-Field Radical Esophagectomy for Esophageal Cancer
This RCT compares three drainage approaches after minimally invasive esophagectomy (chest tube + thoracic mediastinal drainage tube, thoracic, and abdominal mediastinal drainage tube) to evaluate perioperative outcomes, addressing current evidence gaps in pain and complication profiles.
- Conditions
- Esophageal Cancer, Drainage/Methods, Postoperative Pain
- Being tested
- Chest mediastinal tube, Abdominal mediastinal tube, Chest tube + chest mediastinal tube
- Keywords
- Esophageal cancer, Mediastinal drainage tube, Postoperative pain
- Medical subject headings
- Esophageal Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest mediastinal tubeProcedure or surgery
Transthoracic mediastinal drainage was performed for postoperative management of the patient.
Abdominal mediastinal tubeProcedure or surgery
Transperitoneal mediastinal drainage was performed for postoperative management of the patient.
Chest tube + chest mediastinal tubeProcedure or surgery
Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal mediastinal tube | Experimental | Transperitoneal mediastinal drainage was performed for postoperative management of the patient. Receives: Procedure: Abdominal mediastinal tube |
| Chest mediastinal tube | Experimental | Transthoracic mediastinal drainage was performed for postoperative management of the patient. Receives: Procedure: Chest mediastinal tube |
| Chest tube + chest mediastinal tube | Experimental | Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient. Receives: Procedure: Chest tube + chest mediastinal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores
Pain scores were assessed based on the visual analog scale according to the World Health Organization guidelines, in which 0 indicated no pain and 10 indicated the worst possible pain.
We also recorded and evaluated maximum daily pain scores when pain caused by the mediastinal drainage tube incision.
Measured: Pain scores were recorded at different times during the postoperative period when the patients were quiet and active (at 7 AM, 11 AM, 3 PM, and 7 PM) from postoperative day 1 to postoperative day 4.
Secondary outcomes (1)
Postoperative complications
Postoperative complications included anastomotic leak, major pulmonary complications, and major abdominal complications. Pleural effusion was defined as a drainage volume of greater than 800 mL. Pneumothorax was defined by a distance of greater than 3 cm between the apex of the lung and the top of the ribcage on chest radiography.
Measured: Postoperative complications from posoperative day 1 to postoperative month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start30 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hecheng Li, PhD, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004634
- Sponsor's protocol ID
- RTS-026
- Status last verified
- Apr 2025
- First submitted
- 5 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified baseline characteristics, outcomes, and adverse events.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Application Effects of Different Drainage Modes in the Perioperative Period of Minimally Invasive Three-Field Radical Esophagectomy for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT07004634
- Acronym / sponsor ID
- RTS-026
- Conditions
- Esophageal Cancer, Drainage/Methods, Postoperative Pain
- Keywords
- Esophageal cancer, Mediastinal drainage tube, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 4 Jun 2025 (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.
This RCT compares three drainage approaches after minimally invasive esophagectomy (chest tube + thoracic mediastinal drainage tube, thoracic, and abdominal mediastinal drainage tube) to evaluate perioperative outcomes, addressing current evidence gaps in pain and complication profiles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abdominal mediastinal tube | Experimental | Procedure: Abdominal mediastinal tubeTransperitoneal mediastinal drainage was performed for postoperative management of the patient. |
| Chest mediastinal tube | Experimental | Procedure: Chest mediastinal tubeTransthoracic mediastinal drainage was performed for postoperative management of the patient. |
| Chest tube + chest mediastinal tube | Experimental | Procedure: Chest tube + chest mediastinal tubeChest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Pathologically confirmed esophageal cancer requiring three-incision esophagectomy (cervical, thoracic, and abdominal incisions)
- ASA physical status class I-III
Key exclusion criteria (4 listed)
- History of chronic pain or long-term use of analgesics prior to surgery
- Severe cardiopulmonary dysfunction (e.g., FEV1 <50%)
- Coagulation disorders or patients undergoing reoperation
- Intraoperative findings of extensive pleural adhesions, combined resection of adjacent organs, or other conditions deemed by the investigator to warrant exclusion
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 |
|---|---|---|
| Chest mediastinal tubeTransthoracic mediastinal drainage was performed for postoperative management of the patient. | Procedure or surgery | Chest mediastinal tube |
| Abdominal mediastinal tubeTransperitoneal mediastinal drainage was performed for postoperative management of the patient. | Procedure or surgery | Abdominal mediastinal tube |
| Chest tube + chest mediastinal tubeChest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient. | Procedure or surgery | Chest tube + chest mediastinal tube |
Primary outcome
Postoperative Pain Scores
Time frame: Pain scores were recorded at different times during the postoperative period when the patients were quiet and active (at 7 AM, 11 AM, 3 PM, and 7 PM) from postoperative day 1 to postoperative day 4.
Pain scores were assessed based on the visual analog scale according to the World Health Organization guidelines, in which 0 indicated no pain and 10 indicated the worst possible pain. We also recorded and evaluated maximum daily pain scores when pain caused by the mediastinal drainage tube incision.
1 secondary outcome
Postoperative complications
Time frame: Postoperative complications from posoperative day 1 to postoperative month 3
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 10 Jun 2025.
- Individual participant dataSharing planned: Yes. De-identified baseline characteristics, outcomes, and adverse events.
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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.
Hecheng Li, PhD, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest mediastinal tube, Abdominal mediastinal tube and Chest tube + chest mediastinal tube in people with Esophageal Cancer and Drainage/Methods, 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 3 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: looking for participants now, as of the sponsor's last update on 10 Jun 2025. 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 Hecheng Li, PhD, MD (00862164370045 ext. 664566, lihecheng2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Scores (time frame: Pain scores were recorded at different times during the postoperative period when the patients were quiet and active (at 7 AM, 11 AM, 3 PM, and 7 PM) from postoperative day 1 to postoperative day 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.