Epiphora Due to Insufficient Drainage, Left SideNCT05812495
Minimally Invasive Intrathoracic Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis
A study testing Esophagogastric Side to Side Anastomosis and Esophagogastric End to Side Anastomosis in people with Epiphora Due to Insufficient Drainage, Left Side and Epiphora Due to Insufficient Drainage, Right Side, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epiphora Due to Insufficient Drainage, Left Side, Epiphora Due to Insufficient Drainage, Right Side
- What is being tested?
- Esophagogastric Side to Side Anastomosis and Esophagogastric End to Side Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Peng Tang, MD, 18622221615, tangpeng1028@126.com
About this study
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
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.
Read the 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).
- Conditions
- Epiphora Due to Insufficient Drainage, Left Side, Epiphora Due to Insufficient Drainage, Right Side
- Being tested
- Esophagogastric Side to Side Anastomosis, Esophagogastric End to Side Anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagogastric Side to Side AnastomosisProcedure or surgery
Esophagogastric Side to Side Anastomosis
Esophagogastric End to Side AnastomosisProcedure or surgery
Esophagogastric End to Side Anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Esophagogastric Side to Side Anastomosis | Experimental | Esophagogastric Side to Side Anastomosis Receives: Procedure: Esophagogastric Side to Side Anastomosis |
| Esophagogastric End to Side Anastomosis | Experimental | Esophagogastric End to Side Anastomosis Receives: Procedure: Esophagogastric End to Side Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of anastomotic leakage within 3 months after operation
The rate of anastomotic leakage within 3 months after operation
Measured: 3 months
Secondary outcomes (1)
Incidence rate and occurrence time of anastomotic stenosis after operation
Incidence rate and occurrence time of anastomotic stenosis after operation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiphora Due to Insufficient Drainage, Left SideStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- 402 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Tang, Tianjin Medical University Cancer Institute and Hospital
- Investigators
- Peng Tang, MD., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812495
- Sponsor's protocol ID
- CESS2021TB01
- Status last verified
- Apr 2023
- First submitted
- 22 Dec 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05812495
- Acronym / sponsor ID
- CESS2021TB01
- Conditions
- Epiphora Due to Insufficient Drainage, Left Side, Epiphora Due to Insufficient Drainage, Right Side
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Apr 2023 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esophagogastric Side to Side Anastomosis | Experimental | Procedure: Esophagogastric Side to Side AnastomosisEsophagogastric Side to Side Anastomosis |
| Esophagogastric End to Side Anastomosis | Experimental | Procedure: Esophagogastric End to Side AnastomosisEsophagogastric End to Side Anastomosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
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 |
|---|---|---|
| Esophagogastric Side to Side AnastomosisEsophagogastric Side to Side Anastomosis | Procedure or surgery | Esophagogastric Side to Side Anastomosis |
| Esophagogastric End to Side AnastomosisEsophagogastric End to Side Anastomosis | Procedure or surgery | Esophagogastric End to Side Anastomosis |
Primary outcome
The rate of anastomotic leakage within 3 months after operation
Time frame: 3 months
The rate of anastomotic leakage within 3 months after operation
1 secondary outcome
Incidence rate and occurrence time of anastomotic stenosis after operation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Peng Tang, MD. principal investigator
Tianjin Medical University Cancer Institute and 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 Esophagogastric Side to Side Anastomosis and Esophagogastric End to Side Anastomosis in people with Epiphora Due to Insufficient Drainage, Left Side and Epiphora Due to Insufficient Drainage, Right Side, run by Tianjin Medical University Cancer Institute and Hospital 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 22 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongdian Zhang, MD. (13516261036, zhdian0602@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of anastomotic leakage within 3 months after operation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2023.