AdenocarcinomaNCT02741778
Minimally Invasive Sweet Esophagectomy for Patients With Siewert Type II Adenocarcinoma of the Esophagogastric Junction
A study testing Minimally invasive group and Open group in people with Adenocarcinoma, run by Anhui Provincial Hospital.
Trial summary
Of the esophagogastric junction adenocarcinoma (AEG) is a 5 cm region of adenocarcinoma of the esophagus and stomach. Due to the special anatomical location, the biological behavior of esophageal cancer and gastric cancer are not the same. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Minimally invasive group and Open group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2017
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- under 70 years of age (taking into account the follow-up period); B. was performed in patients with cT1~3N0~1M0 type II type cTNM, C., F., D., e., and 5 years.
Who cannot join
- I A., type III esophageal gastric junction adenocarcinoma; B. major organ function can not tolerate surgery; C. advanced patients.
About this study
Of the esophagogastric junction adenocarcinoma (AEG) is a 5 cm region of adenocarcinoma of the esophagus and stomach. Due to the special anatomical location, the biological behavior of esophageal cancer and gastric cancer are not the same. For the resection of esophageal gastric junction adenocarcinoma, the main treatment method for the treatment of surgical treatment.
For the type II type of esophageal gastric junction adenocarcinoma, the mainstream of the traditional surgical approach for the left chest to open the chest, for the lesions of the small type of esophageal gastric junction adenocarcinoma can be performed minimally invasive Ivor-Lewis esophageal resection.
There is no reasonable standard for treatment of type II type esophageal gastric junction adenocarcinoma. The investigators sum up the experience of the past in the minimally invasive resection of esophageal cancer, and combine domestic and foreign research results. Pioneered by laparoscopic mobilization of the stomach and dissection of the abdominal field lymph node + thoracoscopic (left thoracic approach) to free the esophagus and cleaning + mirror under the purse string forceps esophagogastric aortic arch anastomosis under lower mediastinal lymph node, corresponding to the operation is the traditional through left thoracotomy combined with open operation on diaphragm. Can achieve the same with the traditional surgical resection of the tumor, while taking into account the characteristics of minimally invasive surgery. This study intends to provide a minimally invasive surgical treatment of the chest laparoscopy combined with minimally invasive surgery and traditional thoracotomy. Comparison of different surgical methods for patients with the safety of surgery, oncology resection range, the incidence of short-term complications. The effect of different surgical methods on the survival rate and quality of life of the two groups were compared with the postoperative follow-up. The surgical treatment of esophageal carcinoma with a reasonable level of type II type of esophageal gastric junction adenocarcinoma is improved, and the surgical treatment of esophageal gastric junction adenocarcinoma is improved.
Read the detailed description
Of the esophagogastric junction adenocarcinoma (AEG) is a 1 region of the 5 cm region in the esophageal gastric junction. Due to the special anatomical location, the biological behavior of esophageal cancer and gastric cancer are not the same. Because of its wide range of lesions, the majority of the Siewert classification system will be divided into three types: I type, CM type, CM 1-5, which is the 5 cm of the CM L, which is the traditional meaning of cardiac carcinoma. In the investigators country, the majority of patients with type II and III are 2,3,4. For the resection of esophageal gastric junction adenocarcinoma, the main treatment method for the treatment of surgical treatment. The high incidence of type II and type III AEG, type III patients more than the use of the abdominal approach to the proximal gastrectomy, more than by the Department of general surgery. In patients with lesions, the lymph node metastasis is also characterized by a bidirectional transfer of the lymph nodes and the peritoneal cavity with the lesion of the two boundary. In order to ensure that the upper cut edge of the esophagus and the dissection of the mediastinal lymph nodes, the domestic more by the Department of thoracic surgery. For the part of the patients, the traditional standard surgical approach to the left thoracic approach with open phrenoesophageal, partial resection of the stomach, aortic arch esophagogastric anastomosis + thoraco abdominal 2-field lymph node dissection dissection [5,6]. The minimally invasive surgery in the treatment of esophageal cancer and gastric cancer has been widely accepted by domestic and foreign counterparts. For I type AEG patients with type Ivor-Lewis and type III AEG patients are commonly used in the treatment of gastric cancer, and the corresponding minimally invasive surgery has a certain development [7,8]. And for type II AEG patients with relatively standard minimally invasive surgery, there is no unit carried out at home and abroad. Therefore, how to choose the minimally invasive method to complete this operation is more thorough. It has become a hot research topic in the domestic and foreign doctors. It has very important clinical significance and application prospect.
For the type II type of esophageal gastric junction adenocarcinoma, the mainstream of the traditional surgical method for the left chest approach to open the chest. The operation has the following disadvantages: 1) the integrity of the chest wall and diaphragm, the impact of the chest and abdomen of patients with large, close to the long-term life quality is greatly affected by the traditional surgery using the right side of the chest, abdominal lymph node dissection through the diaphragm to complete, and its complete abdominal approach to the poor. The foreign part of the center for smaller lesions of type II esophageal gastric junction adenocarcinoma underwent minimally invasive Ivor Lewis esophagectomy, but it exists the following drawbacks: 1) is not suitable for larger tumors; 2) gastric resection is not enough, the type of esophageal and gastric junction adenocarcinoma essence should be a special type of gastric carcinoma, proximal gastric resection should be for the removal of one of the standard. And the position of the operation is relatively high, which can lead to a large number of esophageal resection, and the length of esophageal resection is more than 3. The 5cm is sufficient. Therefore, how to implement a minimally invasive surgical approach to the upper and lower middle and upper mediastinal and abdominal lymph nodes is a hot research topic in the field of esophageal gastric junction adenocarcinoma.
Up to now, there is no reasonable standard minimally invasive surgery for treatment of type II esophageal gastric junction adenocarcinoma. The investigators sum up the experience of the past in the minimally invasive resection of esophageal cancer, and combine domestic and foreign research results. Pioneered by laparoscopic mobilization of the stomach and dissection of the abdominal field lymph node + thoracoscopic (left thoracic approach) to free the esophagus and cleaning + mirror under the purse string forceps esophagogastric aortic arch anastomosis under lower mediastinal lymph node, corresponding to the operation is the traditional through left thoracotomy combined with open operation on diaphragm. Can achieve the same with the traditional surgical resection of the tumor, while taking into account the characteristics of minimally invasive surgery. In this study, cases of type II esophageal gastric junction adenocarcinoma cases were collected from 120 patients with type II esophageal gastric junction adenocarcinoma by prospective randomized controlled clinical trial. Comparison of different surgical methods for patients with the safety of surgery, oncology resection range, the incidence of short-term complications. The effect of different surgical methods on the survival rate and quality of life of the two groups were compared with the postoperative follow-up. The surgical treatment of esophageal carcinoma with a reasonable level of type II type of esophageal gastric junction adenocarcinoma is improved, and the surgical treatment of esophageal gastric junction adenocarcinoma is improved.
- Conditions
- Adenocarcinoma
- Being tested
- Minimally invasive group, Open group
- Keywords
- Esophagogastric Junction, Adenocarcinoma, Cardia
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive groupProcedure or surgery
In this group, all manipulations are finished by laparoscopy and thoracoscopy.
Open groupProcedure or surgery
Right lateral position, Traditional thoracotomy through the 7th intercostal incision.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive group | Other | In this group, all manipulations are finished by laparoscopy and thoracoscopy.
1. Horizontal position, undergoing laparoscopy through 5-port method. The sequence: gastric mobilization, lymph nodes dissection(including paracardial nodes, left gastric nodes, and detecting splenic nodes and common hepatic nodes ), gastric tube making, and jejunostomy.
2. Left lateral position, undergoing thoracoscopy through 3-port method. The sequence: mobilization of lower esophagus, lower paraesophagesl nodes and diaphragmatic nodes dissection, gastro-esophageal anastomosis by using CEEA. Receives: Procedure: Minimally invasive group |
| Open group | Other | Right lateral position, Traditional thoracotomy through the 7th intercostal incision. The sequence: mobilization of lower esophagus, lower paraesophagesl nodes and diaphragmatic nodes dissection.
Then,oped the diaphragm,undergoing gastric mobilization, lymph nodes dissection(including paracardial nodes, left gastric nodes, and detecting splenic nodes and common hepatic nodes), gastric tube making, gastro-esophageal anastomosis by using CEEA. Nasointestinal tube is placed for feeding. Receives: Procedure: Open group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of lymph nodes dissection
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
the number of positive lymph nodes
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741778
- Sponsor's protocol ID
- 1501041143
- Status last verified
- Apr 2016
- First submitted
- 2 Nov 2015
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Sweet Esophagectomy for Patients With Siewert Type II Adenocarcinoma of the Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT02741778
- Acronym / sponsor ID
- 1501041143
- Conditions
- Adenocarcinoma
- Keywords
- Esophagogastric Junction, Adenocarcinoma, Cardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Apr 2016 (estimated)
- 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.
Of the esophagogastric junction adenocarcinoma (AEG) is a 5 cm region of adenocarcinoma of the esophagus and stomach. Due to the special anatomical location, the biological behavior of esophageal cancer and gastric cancer are not the same. For the resection of esophageal gastric junction adenocarcinoma, the main treatment method for the treatment of surgical treatment.
For the type II type of esophageal gastric junction adenocarcinoma, the mainstream of the traditional surgical approach for the left chest to open the chest, for the lesions of the small type of esophageal gastric junction adenocarcinoma can be performed minimally invasive Ivor-Lewis esophageal resection.
There is no reasonable standard for treatment of type II type esophageal gastric junction adenocarcinoma. The investigators sum up the experience of the past in the minimally invasive resection of esophageal cancer, and combine domestic and foreign research results. Pioneered by laparoscopic mobilization of the stomach and dissection of the abdominal field lymph node + thoracoscopic (left thoracic approach) to free the esophagus and cleaning + mirror under the purse string forceps esophagogastric aortic arch anastomosis under lower mediastinal lymph node, corresponding to the operation is the traditional through left thoracotomy combined with open operation on diaphragm. Can achieve the same with the traditional surgical resection of the tumor, while taking into account the characteristics of minimally invasive surgery. This study intends to provide a minimally invasive surgical treatment of the chest laparoscopy combined with minimally invasive surgery and traditional thoracotomy. Comparison of different surgical methods for patients with the safety of surgery, oncology resection range, the incidence of short-term complications. The effect of different surgical methods on the survival rate and quality of life of the two groups were compared with the postoperative follow-up. The surgical treatment of esophageal carcinoma with a reasonable level of type II type of esophageal gastric junction adenocarcinoma is improved, and the surgical treatment of esophageal gastric junction adenocarcinoma is improved.
Detailed description
Of the esophagogastric junction adenocarcinoma (AEG) is a 1 region of the 5 cm region in the esophageal gastric junction. Due to the special anatomical location, the biological behavior of esophageal cancer and gastric cancer are not the same. Because of its wide range of lesions, the majority of the Siewert classification system will be divided into three types: I type, CM type, CM 1-5, which is the 5 cm of the CM L, which is the traditional meaning of cardiac carcinoma. In the investigators country, the majority of patients with type II and III are 2,3,4. For the resection of esophageal gastric junction adenocarcinoma, the main treatment method for the treatment of surgical treatment. The high incidence of type II and type III AEG, type III patients more than the use of the abdominal approach to the proximal gastrectomy, more than by the Department of general surgery. In patients with lesions, the lymph node metastasis is also characterized by a bidirectional transfer of the lymph nodes and the peritoneal cavity with the lesion of the two boundary. In order to ensure that the upper cut edge of the esophagus and the dissection of the mediastinal lymph nodes, the domestic more by the Department of thoracic surgery. For the part of the patients, the traditional standard surgical approach to the left thoracic approach with open phrenoesophageal, partial resection of the stomach, aortic arch esophagogastric anastomosis + thoraco abdominal 2-field lymph node dissection dissection [5,6]. The minimally invasive surgery in the treatment of esophageal cancer and gastric cancer has been widely accepted by domestic and foreign counterparts. For I type AEG patients with type Ivor-Lewis and type III AEG patients are commonly used in the treatment of gastric cancer, and the corresponding minimally invasive surgery has a certain development [7,8]. And for type II AEG patients with relatively standard minimally invasive surgery, there is no unit carried out at home and abroad. Therefore, how to choose the minimally invasive method to complete this operation is more thorough. It has become a hot research topic in the domestic and foreign doctors. It has very important clinical significance and application prospect.
For the type II type of esophageal gastric junction adenocarcinoma, the mainstream of the traditional surgical method for the left chest approach to open the chest. The operation has the following disadvantages: 1) the integrity of the chest wall and diaphragm, the impact of the chest and abdomen of patients with large, close to the long-term life quality is greatly affected by the traditional surgery using the right side of the chest, abdominal lymph node dissection through the diaphragm to complete, and its complete abdominal approach to the poor. The foreign part of the center for smaller lesions of type II esophageal gastric junction adenocarcinoma underwent minimally invasive Ivor Lewis esophagectomy, but it exists the following drawbacks: 1) is not suitable for larger tumors; 2) gastric resection is not enough, the type of esophageal and gastric junction adenocarcinoma essence should be a special type of gastric carcinoma, proximal gastric resection should be for the removal of one of the standard. And the position of the operation is relatively high, which can lead to a large number of esophageal resection, and the length of esophageal resection is more than 3. The 5cm is sufficient. Therefore, how to implement a minimally invasive surgical approach to the upper and lower middle and upper mediastinal and abdominal lymph nodes is a hot research topic in the field of esophageal gastric junction adenocarcinoma.
Up to now, there is no reasonable standard minimally invasive surgery for treatment of type II esophageal gastric junction adenocarcinoma. The investigators sum up the experience of the past in the minimally invasive resection of esophageal cancer, and combine domestic and foreign research results. Pioneered by laparoscopic mobilization of the stomach and dissection of the abdominal field lymph node + thoracoscopic (left thoracic approach) to free the esophagus and cleaning + mirror under the purse string forceps esophagogastric aortic arch anastomosis under lower mediastinal lymph node, corresponding to the operation is the traditional through left thoracotomy combined with open operation on diaphragm. Can achieve the same with the traditional surgical resection of the tumor, while taking into account the characteristics of minimally invasive surgery. In this study, cases of type II esophageal gastric junction adenocarcinoma cases were collected from 120 patients with type II esophageal gastric junction adenocarcinoma by prospective randomized controlled clinical trial. Comparison of different surgical methods for patients with the safety of surgery, oncology resection range, the incidence of short-term complications. The effect of different surgical methods on the survival rate and quality of life of the two groups were compared with the postoperative follow-up. The surgical treatment of esophageal carcinoma with a reasonable level of type II type of esophageal gastric junction adenocarcinoma is improved, and the surgical treatment of esophageal gastric junction adenocarcinoma is improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive group | Other | Procedure: Minimally invasive groupIn this group, all manipulations are finished by laparoscopy and thoracoscopy. 1. Horizontal position, undergoing laparoscopy through 5-port method. The sequence: gastric mobilization, lymph nodes dissection(including paracardial nodes, left gastric nodes, and detecting splenic nodes and common hepatic nodes ), gastric tube making, and jejunostomy. 2. Left lateral position, undergoing thoracoscopy through 3-port method. The sequence: mobilization of lower esophagus, lower paraesophagesl nodes and diaphragmatic nodes dissection, gastro-esophageal anastomosis by using CEEA. |
| Open group | Other | Procedure: Open groupRight lateral position, Traditional thoracotomy through the 7th intercostal incision. The sequence: mobilization of lower esophagus, lower paraesophagesl nodes and diaphragmatic nodes dissection. Then,oped the diaphragm,undergoing gastric mobilization, lymph nodes dissection(including paracardial nodes, left gastric nodes, and detecting splenic nodes and common hepatic nodes), gastric tube making, gastro-esophageal anastomosis by using CEEA. Nasointestinal tube is placed for feeding. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- under 70 years of age (taking into account the follow-up period); B. was performed in patients with cT1~3N0~1M0 type II type cTNM, C., F., D., e., and 5 years.
Key exclusion criteria (1 listed)
- I A., type III esophageal gastric junction adenocarcinoma; B. major organ function can not tolerate surgery; C. advanced patients.
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 groupIn this group, all manipulations are finished by laparoscopy and thoracoscopy. | Procedure or surgery | Minimally invasive group |
| Open groupRight lateral position, Traditional thoracotomy through the 7th intercostal incision. | Procedure or surgery | Open group |
Primary outcome
the number of lymph nodes dissection
Time frame: through study completion, an average of 1 year
1 secondary outcome
the number of positive lymph nodes
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive group and Open group in people with Adenocarcinoma, run by Anhui Provincial Hospital.
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 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
the number of lymph nodes dissection (time frame: through study completion, an average of 1 year). 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 18 Apr 2016.