MedDataX Logo

Length of the Proximal Resection Margin for Siewert-II/Siewert-III Tumors

NCT ID: NCT02313688

Last Updated: 2017-12-11

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The incidence of adenocarcinomas of the esophagogastric junction (AEJ) has increased rapidly during the past decades. By the Siewert classification, the AEJ is the tumor center located 5 cm above the anatomic cardia and 5 cm below it, which is divided into three individual subtypes. Complete tumor resection is the primary therapy strategies for tumors of the AEJ. The Japan Clinical Oncology Group 9502 (JCOG 9502) found that transabdominal or transhiatal approach gastrectomy has better survival outcomes compared with left thoracoabdominal approach surgery for Siewert II/III tumors. Transabdominal approach gastrectomy is recommended as the standard treatment strategy for Siewert II/III tumors by the guidelines of the Japanese Gastric Cancer Association (JGCA). However, the length of the proximal resection margin for Siewert-II/III tumors by transabdominal/transhiatal gastrectomy is still controversies. Previous study found that longer than 2cm proximal resection margin had better survival outcome than less than 2cm proximal resection margin for Siewert-II/III tumors. On the other sides, due to more advanced tumor stage of patients in China when compared with Japan and Korea. It is necessary to conduct a randomized control study to analyze the length of resection margin in advanced adenocarcinomas of esophagogastric junction.

Therefore, this study was aimed to include those Siewert II/III tumor patients in Gastrointestinal Surgery Department, West China Hospital, Sichuan University to analyze the relationship between the length of proximal resection margin and survival outcomes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Standard Operating Procedure (SOP)

1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
2. Randomization: Intraoperative evaluation found that transabdominal or transhiatal R0, D2 lymphadenectomy, total gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
3. Surgical procedures: The surgical treatments is adopted the total gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Patients in the Group A with 3cm length proximal resection margin and patients in the Group B with 5cm length proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin. If the positive resection margin is found by the intraoperative frozen section, supplementary resection was depend on the characteristics of each patients. Whether these patients with supplementary resection, the length of supplementary resection and the times of the supplementary resection are all needed to record. The two study will take the similar surgical procedures except for the length of the resection margin.
4. Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
5. Follow-up: The follow-up of this study divide into two parts, the postoperative complications and survival outcomes. The postoperative complications is graded by the Clavien-Dindo classification. The survival outcomes included recurrence type, relapse free survival (months) and the overall survival (months).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stomach Neoplasms Siewert Type II Adenocarcinoma of Esophagogastric Junction Recurrence Siewert Type III Adenocarcinoma of Esophagogastric Junction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

adenocarcinomas of esophagogastric junction resection margin length prognosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Group A: Patients in the Group A will underwent D2 total gastrectomy and with 3±0.5 cm lengthen proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin.

Group Type EXPERIMENTAL

gastrectomy

Intervention Type PROCEDURE

Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 3±0.5 cm lengthen proximal resection margin.

Group B

Patients in the Group B will underwent D2 total gastrectomy and with 5±0.5 cm lengthen proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin.

Group Type EXPERIMENTAL

gastrectomy

Intervention Type PROCEDURE

Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 5±0.5 cm lengthen proximal resection margin.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gastrectomy

Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 3±0.5 cm lengthen proximal resection margin.

Intervention Type PROCEDURE

gastrectomy

Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 5±0.5 cm lengthen proximal resection margin.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Preoperative endoscopy and biopsy confirmed upper third gastric adenocarcinoma (Siewert-II/Siewert-III), and predictively feasible of radical total gastrectomy;
2. Predictively resectable diseases, advanced gastric cancer, of preoperative staging JGCA 14th Edition cT2N0M0-T4aN3bM0, Ib-IIIc stage;
3. Age：≤75 years, or ≥18 years;
4. Without serious disease and malignance disease;
5. WHO performance score ≤2, ASA score ≤3;
6. No limit to sexual and race;
7. Informed consent required.

Exclusion Criteria

1. Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc;
2. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
3. Severity mental diseases;
4. Primary lesion cannot be resected in the pattern of transabdominal proximal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
5. After signature the Clinical trial agreement, patients and their agent will quit the trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

West China Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jian-Kun Hu

Prof. of Gastrointestinal Surgery Department.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jian-Kun Hu, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wei-Han Zhang, M.D.

Role: CONTACT

Email: [email protected]

Xin-Zu Chen, M.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wei-Han Zhang, M.D.

Role: primary

Xin-Zu Chen, M.D.

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WCH-GC-02

Identifier Type: -

Identifier Source: org_study_id