Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction

NCT04910789 | Unknown DMC

• 1 other identifier: S2AEG
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction

Conditions

Adenocarcinoma of Esophagogastric Junction

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

  Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up

  3 years after surgery

Secondary Outcomes (5)

• The rate of R0-resection

  About 10 days after surgery

• The number of lymph node dissections and the positive

  About 10 days after surgery

• The duration of postoperative hospitalization

  Within 6 months after surgery

• The incidences of early postoperative complications

  Within 30 days after surgery

• The incidence of perioperative mortality

  Within 30 days after surgery

Study Arms (2)

Thoracoabdominal approach

EXPERIMENTAL

Radical surgery should be finished via Thoracoabdominal approach.

Procedure: thoracoabdominal approach

Transhiatal/transabdominal approach

ACTIVE COMPARATOR

Radical surgery should be finished via transhiatal/transabdominal approach.

Procedure: transhiatal/transabdominal approach

Interventions

transhiatal/transabdominal approach PROCEDURE

Radical surgery should be finished via transhiatal/transabdominal approach

Transhiatal/transabdominal approach

thoracoabdominal approach PROCEDURE

Radical surgery should be finished via thoracoabdominal approach

Thoracoabdominal approach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~75 years old
• The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) .
• Histological diagnosis of adenocarcinoma
• \. American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3
• Informed consent of patients

You may not qualify if:

• Patients with distant metastasis (M1) or invasion of surrounding organs
• History of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer)
• History of other malignant tumors within 5 years
• The researcher believes that the patient is not suitable to participate in the clinical trial
• Patients who persist in withdrawing from clinical trials

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

• Song Q, Li X, Wu D, Li S, Xie T, Lu Y, Zhang L, Xu Z, Liu L, Guo X, Wang X. The abdominal-transhiatal surgical approach versus the thoracoabdominal surgical approach in Siewert type II adenocarcinoma of the esophagogastric junction: protocol for a multicenter prospective, open, parallel, and randomized controlled trial. BMC Cancer. 2022 Mar 24;22(1):318. doi: 10.1186/s12885-022-09375-w.

  PMID: 35331180 DERIVED

Central Study Contacts

Xinxin Wang, Dr

CONTACT

+8613811858199; 301wxx@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 2, 2021
• Study Start: December 11, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

CN (1)