Clinical trial NCT04910789: Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction
Official title: A Prospective, Multicenter, Randomized, Controlled Study Comparing Surgical Efficacy Between Transhiatal/Transabdominal and Thoracoabdominal Approach for Patients With Siewert II Adenocarcinoma of Esophagogastric Junction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenocarcinoma of Esophagogastric Junction
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert Ⅱ adenocarcinoma of esophagogastric junction.

Methods: A prospective, multi-center, randomized, controlled study will be performed. Patients who meet the eligibility criteria will be registered in the study and undergo radical surgery via transhiatal/transabdominal or thoracoabdominal approach. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.

The primary endpoints :3-year disease-free survival. The secondary endpoints:(1) Surgery and oncology indicators ;(2) The incidences of postoperative complications and mortality.

Eligibility criteria: Inclusion Criteria:

* 1.18\~75 years old
* 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) .
* 3.Histological diagnosis of adenocarcinoma
* 4. American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3
* 5.Informed consent of patients

Exclusion Criteria:

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

Primary outcomes:
measure: 3-year disease-free survival
timeFrame: 3 years after surgery
Secondary outcomes:
measure: The rate of R0-resection
timeFrame: About 10 days after surgery
measure: The number of lymph node dissections and the positive
timeFrame: About 10 days after surgery
measure: The duration of postoperative hospitalization
timeFrame: Within 6 months after surgery
measure: The incidences of early postoperative complications
timeFrame: Within 30 days after surgery
measure: The incidence of perioperative mortality
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
citation: 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.