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Minimally Invasive Intrathoracic Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis

Primary Purpose

Epiphora Due to Insufficient Drainage, Left Side, Epiphora Due to Insufficient Drainage, Right Side

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Esophagogastric Side to Side Anastomosis
Esophagogastric End to Side Anastomosis
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiphora Due to Insufficient Drainage, Left Side

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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); The lesion is potentially resectable; CT3-4a and/or N+patients receive neoadjuvant therapy with the informed consent of patients and their families Comprehensive evaluation is suitable for Ivor Lewis operation Aged 18-75 years, both male and female; There was no contraindication in the preoperative examination and evaluation of various organ functions; 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; Lung function: FEV1 ≥ 1.2L, FEV1% ≥ 50% and DLCO ≥ 50% Estimated lifetime ˃ 12 months. R0 resection is expected; The color Doppler ultrasound of the neck showed no suspicious metastatic lymph nodes; Generally in good condition, individual machine energy meter (Karnofsky score, KPS) ≥ 70; Physical status ECOG 0-2 points; 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: Patients with cervical and upper middle thoracic esophageal cancer or Siewert III esophageal gastric junction cancer; 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); Those who can not use stomach to replace esophagus in this operation due to previous operation Previous history of other malignant tumors; Pathological examination of non squamous and non adenocarcinoma patients; Preoperative neoadjuvant chemotherapy and radiotherapy; Severe emphysema and pulmonary fibrosis; 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; Serious uncontrolled systemic diseases, such as active infection or poorly controlled diabetes; 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; Those who already have or are associated with hemorrhagic diseases; People with peripheral nervous system disorder or obvious mental disorder and central nervous system disorder

Sites / Locations

  • Tianjin Medical University Cancer Institute & HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Esophagogastric Side to Side Anastomosis

Esophagogastric End to Side Anastomosis

Arm Description

Esophagogastric Side to Side Anastomosis

Esophagogastric End to Side Anastomosis

Outcomes

Primary Outcome Measures

The rate of anastomotic leakage within 3 months after operation
The rate of anastomotic leakage within 3 months after operation

Secondary Outcome Measures

Incidence rate and occurrence time of anastomotic stenosis after operation
Incidence rate and occurrence time of anastomotic stenosis after operation

Full Information

First Posted
December 22, 2022
Last Updated
April 2, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05812495
Brief Title
Minimally Invasive Intrathoracic Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis
Official Title
A Multicenter,Randomized Controlled Clinical Study of Minimally Invasive Intrathoracic Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis in the Treatment of Lower Esophageal Cancer or Esophageal Gastric Junction Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: Incidence rate and occurrence time of anastomotic stenosis after operation; Reflux esophagitis; 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. Incidence rate of intraoperative accidents 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; Quality of life (EORTC QLQ-C30, EORTC QLQ-OES18), nutritional status score and pain score in January, March, June and year after year; Patient compliance, adverse event (AE) related to treatment, incidence and severity of serious adverse events; 1, 2 and 3 year Progression free survival (PFS) and Overall survival (OS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora Due to Insufficient Drainage, Left Side, Epiphora Due to Insufficient Drainage, Right Side

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis
Allocation
Randomized
Enrollment
402 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esophagogastric Side to Side Anastomosis
Arm Type
Experimental
Arm Description
Esophagogastric Side to Side Anastomosis
Arm Title
Esophagogastric End to Side Anastomosis
Arm Type
Experimental
Arm Description
Esophagogastric End to Side Anastomosis
Intervention Type
Procedure
Intervention Name(s)
Esophagogastric Side to Side Anastomosis
Intervention Description
Esophagogastric Side to Side Anastomosis
Intervention Type
Procedure
Intervention Name(s)
Esophagogastric End to Side Anastomosis
Intervention Description
Esophagogastric End to Side Anastomosis
Primary Outcome Measure Information:
Title
The rate of anastomotic leakage within 3 months after operation
Description
The rate of anastomotic leakage within 3 months after operation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence rate and occurrence time of anastomotic stenosis after operation
Description
Incidence rate and occurrence time of anastomotic stenosis after operation
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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); The lesion is potentially resectable; CT3-4a and/or N+patients receive neoadjuvant therapy with the informed consent of patients and their families Comprehensive evaluation is suitable for Ivor Lewis operation Aged 18-75 years, both male and female; There was no contraindication in the preoperative examination and evaluation of various organ functions; 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; Lung function: FEV1 ≥ 1.2L, FEV1% ≥ 50% and DLCO ≥ 50% Estimated lifetime ˃ 12 months. R0 resection is expected; The color Doppler ultrasound of the neck showed no suspicious metastatic lymph nodes; Generally in good condition, individual machine energy meter (Karnofsky score, KPS) ≥ 70; Physical status ECOG 0-2 points; 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: Patients with cervical and upper middle thoracic esophageal cancer or Siewert III esophageal gastric junction cancer; 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); Those who can not use stomach to replace esophagus in this operation due to previous operation Previous history of other malignant tumors; Pathological examination of non squamous and non adenocarcinoma patients; Preoperative neoadjuvant chemotherapy and radiotherapy; Severe emphysema and pulmonary fibrosis; 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; Serious uncontrolled systemic diseases, such as active infection or poorly controlled diabetes; 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; Those who already have or are associated with hemorrhagic diseases; People with peripheral nervous system disorder or obvious mental disorder and central nervous system disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongdian Zhang, MD.
Phone
13516261036
Email
zhdian0602@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Tang, MD.
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Tang, MD
Phone
18622221615
Email
tangpeng1028@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Minimally Invasive Intrathoracic Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis

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