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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 groups in NCT02741778
Study groupRoleWhat they receive
Minimally invasive groupOtherIn 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 groupOtherRight 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.

  1. the number of lymph nodes dissection

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)
  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.

  1. First posted18 Apr 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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)
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

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.

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