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

NCT ID: NCT04910789

Last Updated: 2021-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-11

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert â…¡ 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.

Conditions

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Adenocarcinoma of Esophagogastric Junction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thoracoabdominal approach

Radical surgery should be finished via Thoracoabdominal approach.

Group Type EXPERIMENTAL

thoracoabdominal approach

Intervention Type PROCEDURE

Radical surgery should be finished via thoracoabdominal approach

Transhiatal/transabdominal approach

Radical surgery should be finished via transhiatal/transabdominal approach.

Group Type ACTIVE_COMPARATOR

transhiatal/transabdominal approach

Intervention Type PROCEDURE

Radical surgery should be finished via transhiatal/transabdominal approach

Interventions

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transhiatal/transabdominal approach

Radical surgery should be finished via transhiatal/transabdominal approach

Intervention Type PROCEDURE

thoracoabdominal approach

Radical surgery should be finished via thoracoabdominal approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1.18\~75 years old
* 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(Siewertâ…¡) .
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lin Chen

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinxin Wang, Dr

Role: CONTACT

+8613811858199

Facility Contacts

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Xinxin Wang, Dr.

Role: primary

+8613811858199

References

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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.

Reference Type DERIVED
PMID: 35331180 (View on PubMed)

Other Identifiers

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S2AEG

Identifier Type: -

Identifier Source: org_study_id

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