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Trial Title:
Minimally Invasive Intrathoracic Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis
NCT ID:
NCT05812495
Condition:
Epiphora Due to Insufficient Drainage, Left Side
Epiphora Due to Insufficient Drainage, Right Side
Conditions: Official terms:
Lacrimal Apparatus Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis
Intervention:
Intervention type:
Procedure
Intervention name:
Esophagogastric Side to Side Anastomosis
Description:
Esophagogastric Side to Side Anastomosis
Arm group label:
Esophagogastric Side to Side Anastomosis
Intervention type:
Procedure
Intervention name:
Esophagogastric End to Side Anastomosis
Description:
Esophagogastric End to Side Anastomosis
Arm group label:
Esophagogastric End to Side Anastomosis
Summary:
On the basis of minimally invasive Ivor Lewis operation for the treatment of lower
thoracic esophageal cancer or esophageal gastric junction cancer, the purpose of this
study is to compare the probability of anastomotic leakage and stenosis after
esophagogastric side to side anastomosis and esophagogastric end to side anastomosis,
combined with the probability of complications, quality of life and survival rate of
patients after the two anastomotic methods, To explore which anastomotic method is better
than the worse for patients with lower thoracic esophageal cancer or cancer at the
junction of esophagus and stomach. This study explored a minimally invasive anastomotic
method with lower incidence of complications and higher quality of life for patients
during Ivor Lewis surgery, which can increase the clinical benefits of patients, improve
the quality of life, and extend the survival period, and has important clinical value.
Detailed description:
To carry out a multicenter, prospective, randomized controlled, phase III clinical study
of minimally invasive Ivor Lewis operation for esophagogastric side to side anastomosis
versus esophagogastric end to side anastomosis in the treatment of lower thoracic
esophageal cancer or esophageal gastric junction cancer. Before grouping, introduce the
similarities and differences of surgical methods to all patients, and group the patients
who meet the conditions for inclusion through random control.
The specific groups are as follows:
Test group: intrathoracic esophagogastrostomy with minimally invasive Ivor Lewis
operation
Control group: intrathoracic esophagogastric end-to-end anastomosis under minimally
invasive Ivor Lewis operation
Each patient will be given a unique study number and will remain unchanged throughout the
trial.
Main end points:
The rate of anastomotic leakage within 3 months after operation.
Secondary endpoint:
1. Incidence rate and occurrence time of anastomotic stenosis after operation;
2. Reflux esophagitis;
3. R0 resection rate, minimally invasive conversion rate, operation time, bleeding
volume, number of lymph nodes cleaned, number of lymph node cleaning stations,
positive rate of lymph nodes, pathological stage, chest drainage volume, drainage
tube placement time, gastric tube removal time, time to start eating after
operation, and hospital stay.
4. Incidence rate of intraoperative accidents
5. Incidence rate of perioperative complications (pulmonary infection, cardiovascular
complications, bleeding, chylothorax, pulmonary embolism, incision infection, etc.),
rate of ICU transfer, and 30 day and 90 day mortality rate;
6. Quality of life (EORTC QLQ-C30, EORTC QLQ-OES18), nutritional status score and pain
score in January, March, June and year after year;
7. Patient compliance, adverse event (AE) related to treatment, incidence and severity
of serious adverse events;
8. 1, 2 and 3 year Progression free survival (PFS) and Overall survival (OS).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The clinical staging of pathological and imaging diagnosis was cT1b-4a, N0-2, M0
stage of lower thoracic esophageal squamous cell carcinoma or Siewert type I and
Siewert type II esophageal gastric junction adenocarcinoma (8th UICC-TNM staging);
2. The lesion is potentially resectable;
3. CT3-4a and/or N+patients receive neoadjuvant therapy with the informed consent of
patients and their families
4. Comprehensive evaluation is suitable for Ivor Lewis operation
5. Aged 18-75 years, both male and female;
6. There was no contraindication in the preoperative examination and evaluation of
various organ functions;
7. The following laboratory tests confirmed that the bone marrow, liver and kidney
functions and blood coagulation met the requirements for participating in the study:
Hemoglobin ≥ 9.0g/L;
White blood cell count ≥ 4.0 × 109/L；
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L；
Platelet count ≥ 100 × 109/L；
The international standardized ratio of prothrombin time ≤ 1.5 times the upper limit
of normal value, and part of the thromboplastin time is within the range of normal
value;
Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value or creatinine
clearance ≥ 50 ml/min (Cockcroft Gault formula);
Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);
The level of AST or ALT ≤ 2.5 times the upper limit of normal value (ULN);
Urine protein<2+; If the urine protein ≥ 2+, the 24-hour urine protein quantitative
display must be ≤ 1g;
8. Lung function: FEV1 ≥ 1.2L, FEV1% ≥ 50% and DLCO ≥ 50%
9. Estimated lifetime ˃ 12 months.
10. R0 resection is expected;
11. The color Doppler ultrasound of the neck showed no suspicious metastatic lymph
nodes;
12. Generally in good condition, individual machine energy meter (Karnofsky score, KPS)
≥ 70; Physical status ECOG 0-2 points;
13. The subjects were fully informed of the purpose of the study, voluntarily joined the
study, with good compliance, safety and survival follow-up.
Exclusion Criteria:
1. Patients with cervical and upper middle thoracic esophageal cancer or Siewert III
esophageal gastric junction cancer;
2. Patients with T4b stage inoperable, multiple lymph node enlargement (estimated
metastasis ≥ 3), multistation lymph node enlargement (estimated lymph node
metastasis ≥ 2) or distant metastasis (M1);
3. Those who can not use stomach to replace esophagus in this operation due to previous
operation
4. Previous history of other malignant tumors;
5. Pathological examination of non squamous and non adenocarcinoma patients;
6. Preoperative neoadjuvant chemotherapy and radiotherapy;
7. Severe emphysema and pulmonary fibrosis;
8. Confirmed history of congestive heart failure; Angina pectoris with poorly
controlled medication; Transmural myocardial infarction confirmed by
electrocardiogram (ECG); Poor control of hypertension; Valvular heart disease with
clinical significance; Or high risk uncontrollable arrhythmia;
9. Serious uncontrolled systemic diseases, such as active infection or poorly
controlled diabetes;
10. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), bleeding
tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulant
treatment;
11. Those who already have or are associated with hemorrhagic diseases;
12. People with peripheral nervous system disorder or obvious mental disorder and
central nervous system disorder
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Tang, MD
Phone:
18622221615
Email:
tangpeng1028@126.com
Start date:
March 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05812495
