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Spots Global Cancer Trial Database for Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction

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Trial Identification

Brief Title: Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction

Official Title: A Multicenter Randomized Controlled Study of Siewert II Esophagogastric Junction Adenocarcinoma With Endoscopic Ivor-Lewis Approach Versus Laparoscopic Transabdominal Extended Gastrectomy

Study ID: NCT05356520

Study Description

Brief Summary: The incidence of esophagogastric junction has been increasing in recent years, and surgery is an important method for the treatment of adenoma at the esophagogastric junction. Currently, there is a great controversy about the surgical method of Siewert II, mainly choosing the right chest or the left chest for thoracic surgery. Therefore, it is of great significance to further study the surgical methods of Siewert II esophagogastric junction adenoma. Objective: To compare the safety, feasibility, and clinical efficacy of endoscopic Ivor-Lewis versus laparoscopic extended abdominal gastrectomy for Siewert type Ⅱadenocarcinoma at the resectable esophagogastric junction.

Detailed Description: At present, the main surgical approaches for the treatment of esophagogastric junction adenocarcinoma include single left thoracic incision, 2 right epigastric incisions, 2 left epigastric incisions, 3 cervicothoracoabdominal incisions, and left thoracoabdominal combined incision and esophageal rift through the diaphragm. Siewert type I ESOPHAgogastric junction carcinoma recommends a right thoracic approach, including Ivor-LEIws and McKeown, according to the Chinese Expert consensus for surgical treatment of ESOPHAgogastric junction adenocarcinoma published in 2018. Siwert TYPE III adenoma at esophagogastric junction, esophageal hiatus through diaphragmatic approach is recommended. The surgical approach for siwert type II adenoma at the esophagogastric junction is controversial \[7,8\]. Due to the particularity of siWERT type II lymph node diffusion, it can spread to both posterior mediastinal lymph nodes and abdominal lymph nodes, and a simple esophageal hiatus through the diaphragm may not be enough to clear lymph nodes. Does a combined thoracoabdominal approach improve patient outcomes? In the 1990s and early 2000s, the Japanese Clinical Oncology Organization (JCOG) compared the efficacy of different surgical approaches for esophagogastric junction adenocarcinoma. The trial randomized patients to transesophageal hiatus or left thoracoabdominal combined approach. Results The incidence of postoperative pneumonia was significantly higher in the left thoracoabdominal approach group than in the transesophageal hiatus group (13%vs. 4%, P=0.048), there was no significant difference in the survival rate of Siewert II type ESOPHAgogastric junction tumor between the two groups (P=0.496). To provide the best, targeted treatment for patients with esophagogastric junction adenocarcinoma, radical resection of the tumor should be combined with resection of adjacent lymph nodes. Previous studies have shown that the effect of surgery on the right chest is better than that on the left. Therefore, we asked whether the endoscopic Ivor-Lewis approach was better than the laparoscopic transabdominal enlarged gastrectomy. The right thoracic approach is the recommended approach for siwert type I adenoma at the esophagogastric junction. It has obvious advantages in postoperative esophageal and cardiopulmonary function protection. Currently, there are no clinical trials of endoscopic Ivor-Lewis and laparoscopic extended abdominal gastrectomy for the treatment of siwert type II adenoma at the esophagogastric junction. Endoscopic IVOR-Lewis and laparoscopic transesophageal hiatus test provide new clinical data for the treatment of siwert TYPE II adenoma at the esophagogastric junction, and help standardize the treatment of siwert type II adenoma at the esophagogastric junction. Therefore, based on our experience and foundation of gastrointestinal surgery in the treatment of esophagogastric junction tumors, through practical observation and research on clinical experimental treatment plans, and integration of domestic superior resources, the establishment and improvement of treatment standards for esophagogastric junction adenoma will be further promoted.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Li, Xi'an, Shaanxi, China

Contact Details

Name: xiaohua li, MD,PH.D

Affiliation: Xijing Hospital

Role: STUDY_CHAIR

Name: xianli he, MD,PH.D

Affiliation: Tang-Du Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: peichun sun, MD,PH.D

Affiliation: Henan Provincial People's Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: lei wang, MD,PH.D

Affiliation: General Hospital of Ningxia Medical University

Role: PRINCIPAL_INVESTIGATOR

Name: xuejun sun, MD,PH.D

Affiliation: First Affiliated Hospital of Xi 'an Jiaotong University

Role: PRINCIPAL_INVESTIGATOR

Name: he huang, MD,PH.D

Affiliation: The First Affiliated Hospital of Shanxi Medical University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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