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Minimally Invasive Sweet Esophagectomy for Patients With Siewert Type II Adenocarcinoma of the Esophagogastric Junction

Primary Purpose

Adenocarcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minimally invasive group
Open group
Sponsored by
Anhui Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma focused on measuring Esophagogastric Junction, Adenocarcinoma, Cardia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Can tolerate the cT1~3N0~1M0 phase II type II esophageal gastric junction adenocarcinoma patients with the corresponding operation, the past or present without radiotherapy, chemotherapy, nearly 5 years without any other malignant tumor history. According to the research design, random access to minimally invasive surgery group or traditional open surgery group. The follow-up procedure, if the cause of the disease or the treatment of the disease has been confirmed, such as the need for adjuvant chemotherapy, should be treated accordingly, according to the statistics appear to be accompanied by the interference to explain and deal with.

Inclusion Criteria:

A. 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.

Exclusion Criteria:

I A., type III esophageal gastric junction adenocarcinoma; B. major organ function can not tolerate surgery; C. advanced patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Minimally invasive group

    Open group

    Arm Description

    In this group, all manipulations are finished by laparoscopy and thoracoscopy. 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. 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.

    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.

    Outcomes

    Primary Outcome Measures

    the number of lymph nodes dissection

    Secondary Outcome Measures

    the number of positive lymph nodes

    Full Information

    First Posted
    November 2, 2015
    Last Updated
    April 14, 2016
    Sponsor
    Anhui Provincial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02741778
    Brief Title
    Minimally Invasive Sweet Esophagectomy for Patients With Siewert Type II Adenocarcinoma of the Esophagogastric Junction
    Official Title
    Minimally Invasive Sweet Esophagectomy for Patients With Siewert Type II Adenocarcinoma of the Esophagogastric Junction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Anhui Provincial Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenocarcinoma
    Keywords
    Esophagogastric Junction, Adenocarcinoma, Cardia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Minimally invasive group
    Arm Type
    Other
    Arm Description
    In this group, all manipulations are finished by laparoscopy and thoracoscopy. 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. 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.
    Arm Title
    Open group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Minimally invasive group
    Intervention Description
    In this group, all manipulations are finished by laparoscopy and thoracoscopy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Open group
    Intervention Description
    Right lateral position, Traditional thoracotomy through the 7th intercostal incision.
    Primary Outcome Measure Information:
    Title
    the number of lymph nodes dissection
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    the number of positive lymph nodes
    Time Frame
    through study completion, an average of 1 year
    Other Pre-specified Outcome Measures:
    Title
    Bleeding volume in operation
    Time Frame
    through study completion, an average of 1 year
    Title
    Operation time
    Time Frame
    through study completion, an average of 1 year
    Title
    Postoperative hospitalization days
    Time Frame
    through study completion, an average of 1 year
    Title
    Days after operation with thoracic drainage tube
    Time Frame
    through study completion, an average of 1 year
    Title
    the volume of pleural fluid in the first 3 days after operation
    Time Frame
    through study completion, an average of 1 year
    Title
    Hospitalization expenses
    Time Frame
    through study completion, an average of 1 year
    Title
    Postoperative complications
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Can tolerate the cT1~3N0~1M0 phase II type II esophageal gastric junction adenocarcinoma patients with the corresponding operation, the past or present without radiotherapy, chemotherapy, nearly 5 years without any other malignant tumor history. According to the research design, random access to minimally invasive surgery group or traditional open surgery group. The follow-up procedure, if the cause of the disease or the treatment of the disease has been confirmed, such as the need for adjuvant chemotherapy, should be treated accordingly, according to the statistics appear to be accompanied by the interference to explain and deal with. Inclusion Criteria: A. 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. Exclusion Criteria: I A., type III esophageal gastric junction adenocarcinoma; B. major organ function can not tolerate surgery; C. advanced patients.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Minimally Invasive Sweet Esophagectomy for Patients With Siewert Type II Adenocarcinoma of the Esophagogastric Junction

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