Esophageal CancerNCT05105945
Clinical Study on the Efficacy of Single-port Inflatable Mediastinoscopy Combined With Laparoscopic-assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery for Radical Esophagectomy
A study testing Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery in people with Esophageal Cancer, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
We previously developed a novel non-trans thoracic esophagectomy, the single-port inflatable mediastinoscopy combined with laparoscopy for the radical esophagectomy of esophageal cancer.This study is evaluating the feasibility and safety of radical resection of single-port inflatable mediastinal mirror synchronization… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,164 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2021to 28 Dec 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 75 years old, no gender limit;
- Patients who are diagnosed as esophageal malignant tumor by cytology or histology, and agree to undergo surgical treatment;
- The preoperative clinical tumor staging is T1-2N0-1M0 patients; or T3N1-2M0 patients undergo neoadjuvant treatment (neoadjuvant chemotherapy, neoadjuvant chemoradiation, neoadjuvant radiotherapy, neoadjuvant chemotherapy and immunotherapy, neoadjuvant radiotherapy and immunotherapy After treatment), assess the tumor to achieve partial response (PR) and surgical resection is feasible;
- The tumor is located in the thoracic esophagus;
- The tumor has not invaded the surrounding vital organs and has metastasized far away;
- The function of major organs is basically normal: general anesthesia is acceptable for lung function; NYHA grade of heart function is 0~1;
- Voluntarily sign an informed consent form before the study. The patient and/or his legal representative have the ability to fully understand the content, process and possible adverse reactions of the experiment, and enable the patient to comply with the visits stipulated in the plan;
Who cannot join
- People who suffer from other malignant tumors at the same time;
- Patients with a history of esophagus or gastrectomy;
- Patients with a history of mediastinal surgery or extensive abdominal cavity adhesion;
- Patients with basic diseases such as cardiovascular and cerebrovascular diseases;
- People suffering from mental, mental or neurological diseases;
- Patients with cachexia and severe malnutrition who cannot tolerate surgery;
Show all 11Show fewer
- Recent recurrence of gastric ulcer, history of gastric bleeding and other serious underlying diseases;
- Patients with surgical contraindications such as blood coagulation dysfunction, HIV antibody positive, and poorly controlled clinically severe infections;
- Patients with other comorbid diseases (such as liver and kidney function abnormalities, etc.) or concomitant medications, which may have an impact on the results of this study based on the judgment of the investigator.
- Patients who have participated in other clinical studies;
- Others judged by the investigator to be unsuitable to participate in this clinical trial.
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
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong
Wu xiangwen, 13346652266
Wang xiaojing, 13798967219
About this study
Official title: A Randomized, Controlled, Multi-center Clinical Study on the Efficacy of Single-port Inflatable Mediastinoscopy Combined With Laparoscopic-assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery for Radical Esophagectomy
We previously developed a novel non-trans thoracic esophagectomy, the single-port inflatable mediastinoscopy combined with laparoscopy for the radical esophagectomy of esophageal cancer.This study is evaluating the feasibility and safety of radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.
Read the detailed description
To reduce postoperative pulmonary complications, considerable efforts have been made to develop the nontransthoracic esophagectomy for esophageal cancer. For instance, esophageal stripping and transhiatal esophagectomy are the nontransthoracic operations developed for treatment for esophageal cancer. These methods possess several advantages, including non-thoracotomy, less postoperative pain, less postoperative cardiac and pulmonary complications, and safer for elderly patients. However, these two methods are limited with the poor surgical view, poor mediastinal lymph node dissection (especially upper mediastinal lymph nodes), and high risk of bleeding.
In 2015 and 2016, Prof. Fujiwara has developed novel surgical methods on the dissection of upper mediastinal lymph nodes using single-port mediastinoscopy through the cervical incision and the lower mediastinal lymph nodes (including the subcarinal lymph nodes) by laparoscopy, respectively.For the first time, non-transthoracic radical resection of esophageal cancer could be achieved along with the dissection of all the mediastinal lymph nodes. Based on the Fujiwara's method, we further improved this surgical method to the"single-port inflatable mediastinoscopy combined with laparoscopy for the radical treatment of esophageal cancer"and has successfully performed this novel surgical method for the first case in March 2016. We have completed over 200 cases of radical resection of esophageal carcinoma using this novel surgical technique from May 2016 to August 2021.
This is a prospective, multicenter, open clinical study in which 1164 patients (including 10% drop-off rate) who require surgical treatment are scheduled to be included in the study. Prior to any screening process, each subject / legal guardian should sign the informed consent form. Screening tests are used to determine whether each subject is eligible for the study. Eligible subjects who meet the standard will be treated with radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma and followed up until 5 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.
- Conditions
- Esophageal Cancer
- Being tested
- Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery, Thoracoscopy Combined With Laparoscopic Surgery
- Keywords
- Minimally invasive surgery
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision SurgeryProcedure or surgery
Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery dissects, dissociates and removes the esophagus in the mediastinum through an inflatable endoscopy. Detailed surgical procedures and related instructions have been published in "Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer" J Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11.
Thoracoscopy Combined With Laparoscopic SurgeryProcedure or surgery
Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| Single port inflatable mediastinoscope and synchronized laparoscopic radical resection | Experimental | Detailed surgical procedures and related instructions have been published in "Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer" J Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11. Receives: Procedure: Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery |
| Thoracoscopy combined with laparoscopic radical resection | Active comparator | Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery Receives: Procedure: Thoracoscopy Combined With Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative incidence of cardiopulmonary complications
Perioperative complications include: pulmonary infection, respiratory failure, managed pleural effusion, heart failure, myocardial infarction, managed arrhythmia, anastomotic fistula or gastric fistula, recurrent laryngeal nerve injury, chylothorax, unscheduled reoperation
Measured: Through operation completion, an average of 12 days
disease-free survival（DFS）
The period after Operation treatment [tumor eliminated] when no disease can be detected
Measured: After surgery-related treatment until the tumor recurrence，assessed up to 5 years
overall survival（OS）
When the precise cause of Esophageal cancer death is not specified, this is called the overall survival rate or observed survival rate. Doctors use mean overall survival rates to estimate the patient's prognosis. This is often expressed over standard time periods, like one, five, and ten years.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Secondary outcomes (10)
intraoperative blood loss
Calculation of intraoperative bleeding with ml/kg
Measured: During the operation, an average of 2 hours
Operation time
Calculate the operating time in minutes
Measured: During the operation, an average of 2 hours
Proportion of patients who converted to thoracotomy and laparotomy
The ratio of the number of patients converted to thoracotomy or laparotomy to the total number of patients undergoing surgery
Measured: During the operation, an average of 2 hours
Intraoperative mortality rate
The ratio of the number of patients who died during the operation to the number of patients who underwent the operation
Measured: During the operation, an average of 2 hours
Postoperative hospital stay
The days of postoperative hospitalization
Measured: Through postoperative hospital stay, an average of 4 days
Postoperative pain score
Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation
Measured: An average of 3 days after the operation
Postoperative admission time to ICU
If the patient needs to be transferred to ICU after operation, stay in icu monitoring time should be observed
Measured: An average of 3 days after the operation
Postoperative drainage
Total postoperative thoracic or mediastinal drainage (ml/kg)
Measured: An average of 3 days after the operation
Postoperative retention time of various types of drainage tubes
The retention time of different types of drainage tube
Measured: An average of 3 days after the operation
Number of lymph nodes removed during surgery
The number of dissected lymph nodes reported in the postoperative pathology report
Measured: Pathology report time, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start11 Nov 2021 (estimated)
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Esophageal 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
- Model description
- The Logrank method was used to compare the difference in survival time between the two groups of patients. According to previous literature data, it is estimated that the DFS of the control group is 18 months. Assuming that the DFS of the test group can be extended to 21.6 months (corresponding HR=1.20), the test requires 1048 patients (524 in each group) to achieve α=0.05 This difference can be detected with 80% confidence at the (two-sided) significance level. The trial plans to enroll for 48 months, follow up for 60 months, and conduct a final analysis when 944 patients have tumor progression (recurrence or metastasis). It is estimated that the drop-off rate of patients in the experimental group and the control group is 10%, so 1164 (524×2÷0.9=1164) patients need to be enrolled in the final group. Significance Level：0.05
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Ningxia Medical University, Beijing Chao Yang Hospital, West China Hospital, Shanghai Chest Hospital, Peking University Cancer Hospital & Institute, The First Affiliated Hospital of Nanchang University, Changzhi Medical College, Zhangzhou Affiliated Hospital of Fujian Medical University, Harbin Medical University, Hubei Cancer Hospital, Jining First People's Hospital, Jiangsu Cancer Institute & Hospital, Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Liu Shaoxuan, Study chair, Office of clinical research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105945
- Sponsor's protocol ID
- ZDWY.XXW.005
- Status last verified
- Aug 2021
- First submitted
- 16 Sep 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi AR, Chon NR, Youn YH, Paik HC, Kim YH, Park H. Esophageal cancer in esophageal diverticula associated with achalasia. Clin Endosc. 2015 Jan;48(1):70-3. doi: 10.5946/ce.2015.48.1.70. Epub 2015 Jan 31.
PubMed 25674530Luketich JD, Pennathur A, Franchetti Y, Catalano PJ, Swanson S, Sugarbaker DJ, De Hoyos A, Maddaus MA, Nguyen NT, Benson AB, Fernando HC. Minimally invasive esophagectomy: results of a prospective phase II multicenter trial-the eastern cooperative oncology group (E2202) study. Ann Surg. 2015 Apr;261(4):702-7. doi: 10.1097/SLA.0000000000000993.
PubMed 25575253Wang X, Li X, Cheng H, Zhang B, Zhong H, Wang R, Zhong B, Cao Q. Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer. J Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11.
PubMed 30635830Fujiwara H, Shiozaki A, Konishi H, Kosuga T, Komatsu S, Ichikawa D, Okamoto K, Otsuji E. Single-Port Mediastinoscopic Lymphadenectomy Along the Left Recurrent Laryngeal Nerve. Ann Thorac Surg. 2015 Sep;100(3):1115-7. doi: 10.1016/j.athoracsur.2015.03.122.
PubMed 26354650Fujiwara H, Shiozaki A, Konishi H, Komatsu S, Kubota T, Ichikawa D, Okamoto K, Morimura R, Murayama Y, Kuriu Y, Ikoma H, Nakanishi M, Sakakura C, Otsuji E. Hand-assisted laparoscopic transhiatal esophagectomy with a systematic procedure for en bloc infracarinal lymph node dissection. Dis Esophagus. 2016 Feb-Mar;29(2):131-8. doi: 10.1111/dote.12303. Epub 2014 Dec 9.
PubMed 25487303
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-center Clinical Study on the Efficacy of Single-port Inflatable Mediastinoscopy Combined With Laparoscopic-assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery for Radical Esophagectomy
- ClinicalTrials.gov ID
- NCT05105945
- Acronym / sponsor ID
- ZDWY.XXW.005
- Conditions
- Esophageal Cancer
- Keywords
- Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,164 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- General Hospital of Ningxia Medical University, Beijing Chao Yang Hospital, West China Hospital, Shanghai Chest Hospital, Peking University Cancer Hospital & Institute, The First Affiliated Hospital of Nanchang University, Changzhi Medical College, Zhangzhou Affiliated Hospital of Fujian Medical University, Harbin Medical University, Hubei Cancer Hospital, Jining First People's Hospital, Jiangsu Cancer Institute & Hospital, Nanfang Hospital, Southern Medical University
- Study start
- 11 Nov 2021 (estimated)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2028 (estimated)
- First posted
- 3 Nov 2021 (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.
We previously developed a novel non-trans thoracic esophagectomy, the single-port inflatable mediastinoscopy combined with laparoscopy for the radical esophagectomy of esophageal cancer.This study is evaluating the feasibility and safety of radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.
Detailed description
To reduce postoperative pulmonary complications, considerable efforts have been made to develop the nontransthoracic esophagectomy for esophageal cancer. For instance, esophageal stripping and transhiatal esophagectomy are the nontransthoracic operations developed for treatment for esophageal cancer. These methods possess several advantages, including non-thoracotomy, less postoperative pain, less postoperative cardiac and pulmonary complications, and safer for elderly patients. However, these two methods are limited with the poor surgical view, poor mediastinal lymph node dissection (especially upper mediastinal lymph nodes), and high risk of bleeding.
In 2015 and 2016, Prof. Fujiwara has developed novel surgical methods on the dissection of upper mediastinal lymph nodes using single-port mediastinoscopy through the cervical incision and the lower mediastinal lymph nodes (including the subcarinal lymph nodes) by laparoscopy, respectively.For the first time, non-transthoracic radical resection of esophageal cancer could be achieved along with the dissection of all the mediastinal lymph nodes. Based on the Fujiwara's method, we further improved this surgical method to the"single-port inflatable mediastinoscopy combined with laparoscopy for the radical treatment of esophageal cancer"and has successfully performed this novel surgical method for the first case in March 2016. We have completed over 200 cases of radical resection of esophageal carcinoma using this novel surgical technique from May 2016 to August 2021.
This is a prospective, multicenter, open clinical study in which 1164 patients (including 10% drop-off rate) who require surgical treatment are scheduled to be included in the study. Prior to any screening process, each subject / legal guardian should sign the informed consent form. Screening tests are used to determine whether each subject is eligible for the study. Eligible subjects who meet the standard will be treated with radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma and followed up until 5 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The Logrank method was used to compare the difference in survival time between the two groups of patients. According to previous literature data, it is estimated that the DFS of the control group is 18 months. Assuming that the DFS of the test group can be extended to 21.6 months (corresponding HR=1.20), the test requires 1048 patients (524 in each group) to achieve α=0.05 This difference can be detected with 80% confidence at the (two-sided) significance level. The trial plans to enroll for 48 months, follow up for 60 months, and conduct a final analysis when 944 patients have tumor progression (recurrence or metastasis). It is estimated that the drop-off rate of patients in the experimental group and the control group is 10%, so 1164 (524×2÷0.9=1164) patients need to be enrolled in the final group. Significance Level：0.05
| Arm | Type | Receives |
|---|---|---|
| Single port inflatable mediastinoscope and synchronized laparoscopic radical resection | Experimental | Procedure: Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision SurgeryDetailed surgical procedures and related instructions have been published in "Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer" J Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11. |
| Thoracoscopy combined with laparoscopic radical resection | Active comparator | Procedure: Thoracoscopy Combined With Laparoscopic SurgeryPatients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old ≤ age ≤ 75 years old, no gender limit;
- Patients who are diagnosed as esophageal malignant tumor by cytology or histology, and agree to undergo surgical treatment;
- The preoperative clinical tumor staging is T1-2N0-1M0 patients; or T3N1-2M0 patients undergo neoadjuvant treatment (neoadjuvant chemotherapy, neoadjuvant chemoradiation, neoadjuvant radiotherapy, neoadjuvant chemotherapy and immunotherapy, neoadjuvant radiotherapy and immunotherapy After treatment), assess the tumor to achieve partial response (PR) and surgical resection is feasible;
- The tumor is located in the thoracic esophagus;
- The tumor has not invaded the surrounding vital organs and has metastasized far away;
Key exclusion criteria (11 listed)
- People who suffer from other malignant tumors at the same time;
- Patients with a history of esophagus or gastrectomy;
- Patients with a history of mediastinal surgery or extensive abdominal cavity adhesion;
- Patients with basic diseases such as cardiovascular and cerebrovascular diseases;
- People suffering from mental, mental or neurological diseases;
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 |
|---|---|---|
| Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision SurgerySingle-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery dissects, dissociates and removes the esophagus in the mediastinum through an inflatable endoscopy. Detailed surgical procedures and related instructions have been published in "Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer" J Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11. | Procedure or surgery | Single port inflatable mediastinoscope and synchronized laparoscopic radical resection |
| Thoracoscopy Combined With Laparoscopic SurgeryPatients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery | Procedure or surgery | Thoracoscopy combined with laparoscopic radical resection |
Primary outcome
Perioperative incidence of cardiopulmonary complications
Time frame: Through operation completion, an average of 12 days
Perioperative complications include: pulmonary infection, respiratory failure, managed pleural effusion, heart failure, myocardial infarction, managed arrhythmia, anastomotic fistula or gastric fistula, recurrent laryngeal nerve injury, chylothorax, unscheduled reoperation
disease-free survival（DFS）
Time frame: After surgery-related treatment until the tumor recurrence，assessed up to 5 years
The period after Operation treatment [tumor eliminated] when no disease can be detected
overall survival（OS）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
When the precise cause of Esophageal cancer death is not specified, this is called the overall survival rate or observed survival rate. Doctors use mean overall survival rates to estimate the patient's prognosis. This is often expressed over standard time periods, like one, five, and ten years.
10 secondary outcomes
intraoperative blood loss
Time frame: During the operation, an average of 2 hours
Operation time
Time frame: During the operation, an average of 2 hours
Proportion of patients who converted to thoracotomy and laparotomy
Time frame: During the operation, an average of 2 hours
Intraoperative mortality rate
Time frame: During the operation, an average of 2 hours
Postoperative hospital stay
Time frame: Through postoperative hospital stay, an average of 4 days
Postoperative pain score
Time frame: An average of 3 days after the operation
Postoperative admission time to ICU
Time frame: An average of 3 days after the operation
Postoperative drainage
Time frame: An average of 3 days after the operation
Postoperative retention time of various types of drainage tubes
Time frame: An average of 3 days after the operation
Number of lymph nodes removed during surgery
Time frame: Pathology report time, an average of 4 days
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 3 Nov 2021.
- Results publication: PubMed 25674530Choi AR, Chon NR, Youn YH, Paik HC, Kim YH, Park H. Esophageal cancer in esophageal diverticula associated with achalasia. Clin Endosc. 2015 Jan;48(1):70-3. doi: 10.5946/ce.2015.48.1.70. Epub 2015 Jan 31.
- Results publication: PubMed 25575253Luketich JD, Pennathur A, Franchetti Y, Catalano PJ, Swanson S, Sugarbaker DJ, De Hoyos A, Maddaus MA, Nguyen NT, Benson AB, Fernando HC. Minimally invasive esophagectomy: results of a prospective phase II multicenter trial-the eastern cooperative oncology group (E2202) study. Ann Surg. 2015 Apr;261(4):702-7. doi: 10.1097/SLA.0000000000000993.
- Results publication: PubMed 30635830Wang X, Li X, Cheng H, Zhang B, Zhong H, Wang R, Zhong B, Cao Q. Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer. J Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11.
- Results publication: PubMed 26354650Fujiwara H, Shiozaki A, Konishi H, Kosuga T, Komatsu S, Ichikawa D, Okamoto K, Otsuji E. Single-Port Mediastinoscopic Lymphadenectomy Along the Left Recurrent Laryngeal Nerve. Ann Thorac Surg. 2015 Sep;100(3):1115-7. doi: 10.1016/j.athoracsur.2015.03.122.
- Results publication: PubMed 25487303Fujiwara H, Shiozaki A, Konishi H, Komatsu S, Kubota T, Ichikawa D, Okamoto K, Morimura R, Murayama Y, Kuriu Y, Ikoma H, Nakanishi M, Sakakura C, Otsuji E. Hand-assisted laparoscopic transhiatal esophagectomy with a systematic procedure for en bloc infracarinal lymph node dissection. Dis Esophagus. 2016 Feb-Mar;29(2):131-8. doi: 10.1111/dote.12303. Epub 2014 Dec 9.
- Individual participant dataSharing planned: No
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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.
Liu Shaoxuan study chair
Office of clinical research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery in people with Esophageal Cancer, run by Fifth Affiliated Hospital, Sun Yat-Sen 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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 3 Nov 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?
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 Cao Qingdong, bachelor (+86 13680356988, 13680356988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative incidence of cardiopulmonary complications (time frame: Through operation completion, an average of 12 days). The study lists 3 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 NCT05105945, which also lists 5 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 3 Nov 2021.