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

NCT02741778 | Unknown DMC

• 1 other identifier: 1501041143
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adenocarcinoma

Keywords

Esophagogastric Junction; Adenocarcinoma; Cardia

Outcome Measures

Primary Outcomes (1)

• the number of lymph nodes dissection

  through study completion, an average of 1 year

Secondary Outcomes (1)

• the number of positive lymph nodes

  through study completion, an average of 1 year

Other Outcomes (7)

• Bleeding volume in operation

  through study completion, an average of 1 year

• Operation time

  through study completion, an average of 1 year

• Postoperative hospitalization days

  through study completion, an average of 1 year

Study Arms (2)

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.

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.

Procedure: Open group

Interventions

Minimally invasive group PROCEDURE

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

Minimally invasive group

Open group PROCEDURE

Right lateral position, Traditional thoracotomy through the 7th intercostal incision.

Open group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

MeSH Terms

Conditions

Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: April 18, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 18, 2016

Record last verified: 2016-04