- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05356520
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
June 7, 2022 updated by: xiaohua li, Xijing Hospital of Digestive Diseases
A Multicenter Randomized Controlled Study of Siewert II Esophagogastric Junction Adenocarcinoma With Endoscopic Ivor-Lewis Approach Versus Laparoscopic Transabdominal Extended Gastrectomy
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
212
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: xiaohua Li, MD,PH.D
- Phone Number: +8613474299901
- Email: xjyylixiaohua@163.com
Study Contact Backup
- Name: zhenchang Mo
- Phone Number: +8618700816920
- Email: mzc131208@126.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710000
- Recruiting
- Li
-
Contact:
- xiaohua li, MD,PH.D
- Phone Number: 13474299901
- Email: xjyylixiaohua@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Histologically confirmed EGJ type II adenocarcinoma
··The tumor can be removed by laparoscopy through the gastrodiaphragmatic esophageal hiatus or by endoscopic Ivor Lewis operation
- Pretreatment stage CT1-4A, N0-3, M0
- For cT4a stage patients, their resectable properties must be clearly verified before randomization
- For locally advanced tumors (CT3-T4 or N+), all 4 cycles of chemotherapy (FLOT) were completed before surgery.
- 18 to 75 years old
- ECOG score 0-2
- ASA <4
- Good bone marrow function (leukocyte > x 10 ^ 9 / l; Hemoglobin> 9 g/dl. ·Platelet>100×10^9/ L), renal function (glomerular filtration rate & GT; 60ml/min) and liver function (total bilirubin < 1.5 times normal (ULN), aspartate aminotransferase (AST< 2.5x ULN, Alanine aminotransferase (ALT)<3 x ULN)
- Patients and their family members voluntarily sign written informed consent
Exclusion Criteria:
- Histologically confirmed EGJ type I and III adenocarcinoma
- Tumor spread over 5 cm proximal to EGJ
- Clinically significant (active) heart disease (i.e. symptomatic coronary artery disease or myocardial infarction within the last 12 months) resulting in left ventricular ejection fraction<50%(determined by echocardiography)
- Clinically significant lung diseases (forced expiratory volume in 1 second (FEV1)<1.5 l/s)
- Pregnant women and nursing mothers
- Stump gastric cancer
- Borrmann Type 4 (Leather stomach)
- Simultaneous or heterochronous malignant tumors of other organs except carcinoma in situ of the cervix and adenoma and focal colorectal carcinoma
- Right thoracotomy or history of right pleural adhesion
- Cirrhosis, or indocyanine green test ≥15% of chronic liver disease
- No seizure control, central nervous system diseases or mental disorders
- History of upper abdominal surgery (except laparoscopic cholecystectomy)
- The patient has coagulation dysfunction and cannot be corrected
- Patients with heart, lung, liver, brain, kidney and other important organ failure
- Patients with metabolic diseases such as diabetes
- Immunosuppressive therapy, such as organ transplantation, SLE, etc
- Seriously out of control recurrent infections or other seriously out of control concomitant diseases
- Other diseases requiring simultaneous surgery
- Diseases requiring emergency surgery due to tumor emergencies (e.g. hemorrhage, perforation, obstruction)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The experimental group
Endoscopic ivor-Lewis operation was performed for siwert type II adenoma at the esophagogastric junction
|
Endoscopy Ivor-lewis
|
Active Comparator: The control group
Laparoscopic transabdominal enlarged gastrectomy for siwert TYPE II adenoma at the esophagogastric junction was performed
|
Laparoscopic transabdominal enlarged gastrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival time
Time Frame: three years
|
The time from the date of surgery to the patient's death from any cause
|
three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: five years
|
The time from the date of surgery to the patient's death from any cause
|
five years
|
Incidence of postoperative complications
Time Frame: a month
|
Postoperative complications include anastomotic fistula (clinically or radiologically diagnosed); Respiratory complications (defined as clinical manifestations of pneumonia or bronchopneumonia, confirmed by computed tomography); Cardiovascular complications (defined as persistent arrhythmias requiring treatment); Chylothorax (defined as white fluid in thoracic drainage after enteral nutrition); Wound infection; And other complications (delayed empty.
pleural effusion, recurrent nerve injury)
|
a month
|
Postoperative mortality
Time Frame: a month
|
Postoperative mortality is defined as the proportion of deaths from any cause
|
a month
|
Tumor recurrence
Time Frame: three years
|
Tumor recurrence
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: xiaohua li, MD,PH.D, Xijing Hospital
- Principal Investigator: xianli he, MD,PH.D, Tang-Du Hospital
- Principal Investigator: peichun sun, MD,PH.D, Henan Provincial People's Hospital
- Principal Investigator: lei wang, MD,PH.D, General Hospital of Ningxia Medical University
- Principal Investigator: xuejun sun, MD,PH.D, First Affiliated Hospital of Xi 'an Jiaotong University
- Principal Investigator: he huang, MD,PH.D, The First Affiliated Hospital of Shanxi Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Anticipated)
May 31, 2025
Study Completion (Anticipated)
May 31, 2028
Study Registration Dates
First Submitted
April 27, 2022
First Submitted That Met QC Criteria
April 29, 2022
First Posted (Actual)
May 2, 2022
Study Record Updates
Last Update Posted (Actual)
June 8, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJ MZC 2022 04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Siewert Type II Adenocarcinoma of Esophagogastric Junction
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St. James's Hospital, IrelandUnknownBarrett Esophagus | Siewert Type II Adenocarcinoma of Esophagogastric Junction | Oesophagus Cancer | Siewert Type I Adenocarcinoma of Esophagogastric Junction | Siewert Type III Adenocarcinoma of Esophagogastric JunctionIreland
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Jennifer Eva SelfridgeNot yet recruitingSiewert Type II Adenocarcinoma of Esophagogastric Junction | Adenocarcinoma Esophagus | Siewert Type I Adenocarcinoma of Esophagogastric Junction | Locally Advanced Adenocarcinoma
-
Guangdong Provincial Hospital of Traditional Chinese...RecruitingSiewert Type II Adenocarcinoma of Esophagogastric Junction | Esophagogastric Junction AdenocarcinomaChina
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West China HospitalRecruitingRecurrence | Stomach Neoplasms | Siewert Type II Adenocarcinoma of Esophagogastric Junction | Siewert Type III Adenocarcinoma of Esophagogastric JunctionChina
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P. Herzen Moscow Oncology Research InstituteNational Medical Research Radiological Centre of the Ministry of Health of...Not yet recruitingEsophageal Cancer | Oesophageal Cancer | Siewert Type I Adenocarcinoma of Esophagogastric Junction | Siewert Type III Adenocarcinoma of Esophagogastric JunctionRussian Federation
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AIO-Studien-gGmbHNeovii BiotechCompletedGastric Adenocarcinoma With Peritoneal Carcinomatosis | Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis | Siewert Type III Adenocarcinoma of Esophagogastric Junction With Peritoneal CarcinomatosisGermany
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University of BolognaCompletedSiewert Type II Adenocarcinoma of Esophagogastric JunctionItaly
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Northern Jiangsu People's HospitalCompletedAnti-Reflux Alimentary Reconstruction | Laparoscopic Proximal Gastrectomy | Siewert Type II/III Adenocarcinoma of the Esophagogastric JunctionChina
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P. Herzen Moscow Oncology Research InstituteNational Medical Research Radiological Centre of the Ministry of Health of...Not yet recruitingStomach Cancer | Gastric Cancer | Siewert Type III Adenocarcinoma of Esophagogastric JunctionRussian Federation
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Technical University of MunichCompletedAdenocarcinoma of the Esophagogastric JunctionGermany
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National Taiwan University HospitalUnknownEsophageal Neoplasms | Minimally Invasive | Cancer of Esophagus | Esophagectomy | Surgical Procedures | OperativeTaiwan
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University Hospitals, LeicesterCompleted
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The Second Hospital of Shandong UniversityRecruitingEsophageal CancerChina
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Stefan GutknechtNot yet recruitingSwallowing Disorder | Anastomotic Leak EsophagusSwitzerland
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The Affiliated Nanjing Drum Tower Hospital of Nanjing...RecruitingEsophagogastric Junction CarcinomaChina
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Fudan UniversityShanxi Province Cancer Hospital; The First Hospital of Jilin University; Fujian... and other collaboratorsUnknownEsophageal CancerChina
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Sichuan UniversityUnknownPostoperative Complications | Esophageal Cancer | Pulmonary Function | DiaphragmChina
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Hospital Universitari de BellvitgeUniversity of BarcelonaRecruitingPostoperative Complications | Esophageal Cancer | Esophageal CarcinomaSpain
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Boston Children's HospitalWithdrawnRegional Anesthesia MorbidityUnited States
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Shanghai Zhongshan HospitalZhejiang Cancer Hospital; Sun Yat-sen University; Cancer Institute and Hospital... and other collaboratorsRecruitingEsophageal Squamous Cell Carcinoma Stage II | Esophageal Squamous Cell Carcinoma Stage IIIChina