NCT05356520Recruiting
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
A Multicenter Randomized Controlled Study of Siewert II Esophagogastric Junction Adenocarcinoma With Endoscopic Ivor-Lewis Approach Versus Laparoscopic Transabdominal Extended Gastrectomy
Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 212 (estimated)
- First submitted
- 27 Apr 2022
- Start date
- 1 May 2022
- Primary completion date
- 31 May 2025
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05356520
What you commit to
- Study type: Interventional
- Planned participants: 212
- From 1 May 2022 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immunosuppressive therapy, such as organ transplantation, SLE, etc
- Seriously out of control recurrent infections or other seriously out of control concomitant diseases
Other illness
- Clinically significant lung diseases (forced expiratory volume in 1 second (FEV1)\<1.5 l/s)
- Stump gastric cancer
- 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)
- Patients with heart, lung, liver, brain, kidney and other important organ failure
- Patients with metabolic diseases such as diabetes
- Other diseases requiring simultaneous surgery
- Diseases requiring emergency surgery due to tumor emergencies (e.g. hemorrhage, perforation, obstruction)
Lab values
- 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)
Other
- Histologically confirmed EGJ type I and III adenocarcinoma
- Tumor spread over 5 cm proximal to EGJ
- Pregnant women and nursing mothers
- Borrmann Type 4 (Leather stomach)
- The patient has coagulation dysfunction and cannot be corrected
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Li Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.