Siewert Type II Adenocarcinoma of Esophagogastric JunctionNCT05356520
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
A study testing Endoscopy Ivor-lewis and Laparoscopic transabdominal enlarged gastrectomy in people with Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Siewert Type II Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- Endoscopy Ivor-lewis and Laparoscopic transabdominal enlarged gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Li
Xi'an, Shaanxi, 710000
xiaohua li, MD,PH.D, 13474299901, xjyylixiaohua@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Endoscopy Ivor-lewis, Laparoscopic transabdominal enlarged gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy Ivor-lewisProcedure or surgery
Endoscopy Ivor-lewis
Laparoscopic transabdominal enlarged gastrectomyProcedure or surgery
Laparoscopic transabdominal enlarged gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Endoscopic ivor-Lewis operation was performed for siwert type II adenoma at the esophagogastric junction Receives: Procedure: Endoscopy Ivor-lewis |
| The control group | Active comparator | Laparoscopic transabdominal enlarged gastrectomy for siwert TYPE II adenoma at the esophagogastric junction was performed Receives: Procedure: Laparoscopic transabdominal enlarged gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival time
The time from the date of surgery to the patient's death from any cause
Measured: three years
Secondary outcomes (4)
Overall survival
The time from the date of surgery to the patient's death from any cause
Measured: five years
Incidence of postoperative complications
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)
Measured: a month
Postoperative mortality
Postoperative mortality is defined as the proportion of deaths from any cause
Measured: a month
Tumor recurrence
Tumor recurrence
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 May 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Siewert Type II Adenocarcinoma of Esophagogastric JunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Tang-Du Hospital, Henan Provincial People's Hospital, General Hospital of Ningxia Medical University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Shanxi Medical University
- Responsible party
- Principal investigator, xiaohua li, Xijing Hospital of Digestive Diseases
- Investigators
- xiaohua li, MD,PH.D, Study chair, Xijing Hospitalxianli he, MD,PH.D, Principal investigator, Tang-Du Hospitalpeichun sun, MD,PH.D, Principal investigator, Henan Provincial People's Hospitallei wang, MD,PH.D, Principal investigator, General Hospital of Ningxia Medical Universityxuejun sun, MD,PH.D, Principal investigator, First Affiliated Hospital Xi'an Jiaotong Universityhe huang, MD,PH.D, Principal investigator, The First Affiliated Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356520
- Sponsor's protocol ID
- XJ MZC 2022 04
- Status last verified
- Nov 2024
- First submitted
- 27 Apr 2022
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yue C, Mo Z, Wu X, Wang Y, Yang Q, Wang W, Zhou H, Gao R, Ji P, Dong D, Zhang Y, Ji G, Li X. Comparison of thoracoabdominal versus abdominal-transhiatal surgical approaches in Siewert type II adenocarcinoma at the esophagogastric junction: Protocol for a prospective multicenter randomized controlled trial. Front Oncol. 2023 Mar 30;13:1091615. doi: 10.3389/fonc.2023.1091615. eCollection 2023.
PubMed 37064105
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study of Siewert II Esophagogastric Junction Adenocarcinoma With Endoscopic Ivor-Lewis Approach Versus Laparoscopic Transabdominal Extended Gastrectomy
- ClinicalTrials.gov ID
- NCT05356520
- Acronym / sponsor ID
- XJ MZC 2022 04
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Collaborators
- Tang-Du Hospital, Henan Provincial People's Hospital, General Hospital of Ningxia Medical University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Shanxi Medical University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Procedure: Endoscopy Ivor-lewisEndoscopic ivor-Lewis operation was performed for siwert type II adenoma at the esophagogastric junction |
| The control group | Active comparator | Procedure: Laparoscopic transabdominal enlarged gastrectomyLaparoscopic transabdominal enlarged gastrectomy for siwert TYPE II adenoma at the esophagogastric junction was performed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy Ivor-lewisEndoscopy Ivor-lewis | Procedure or surgery | The experimental group |
| Laparoscopic transabdominal enlarged gastrectomyLaparoscopic transabdominal enlarged gastrectomy | Procedure or surgery | The control group |
Primary outcome
Disease-free survival time
Time frame: three years
The time from the date of surgery to the patient's death from any cause
4 secondary outcomes
Overall survival
Time frame: five years
Incidence of postoperative complications
Time frame: a month
Postoperative mortality
Time frame: a month
Tumor recurrence
Time frame: three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Derived from this study: PubMed 37064105Yue C, Mo Z, Wu X, Wang Y, Yang Q, Wang W, Zhou H, Gao R, Ji P, Dong D, Zhang Y, Ji G, Li X. Comparison of thoracoabdominal versus abdominal-transhiatal surgical approaches in Siewert type II adenocarcinoma at the esophagogastric junction: Protocol for a prospective multicenter randomized controlled trial. Front Oncol. 2023 Mar 30;13:1091615. doi: 10.3389/fonc.2023.1091615. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
xiaohua li, MD,PH.D study chair
Xijing Hospital
xianli he, MD,PH.D principal investigator
Tang-Du Hospital
peichun sun, MD,PH.D principal investigator
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy Ivor-lewis and Laparoscopic transabdominal enlarged gastrectomy in people with Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaohua Li, MD,PH.D (+8613474299901, xjyylixiaohua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival time (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.