Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Pleural Effusion

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Patients enrolled for chest tube positioning

Patients enrolled for diaphragm closure without chest tube positioning

Positioning of Thoracic Drain after diaphragmatic resection and consequently diaphragmatic repair

thoracic Drain Tube 24 Fr.

Stefano Cianci, M.D.

Prospective randomized phase IV study aimed to value the impact of diaphragmatic surgery and the useful of intra-operatory thoracic drain in advanced ovarian cancer.

Considering the fact that the diaphragmatic surgery could contribute with the incidence of post-operatory morbidity. The study is aimed to value the role of thoracic drain in post-operative outcomes as hospital stay, time to chemotherapy, drugs use and eventual interventions.

Ovarian cancer represents the leading cause of death from gynecologic malignancies. The majority of patients present with advanced-stage disease (III/IV) often involving the upper abdomen. Spread by either direct extension or via peritoneal implantation can result in metastases to the diaphragm, as seen in up to 40% of patients with advanced disease.

Standard treatment of advanced-stage disease includes primary cytoreductive surgery followed by combination platinum-taxane chemotherapy. Optimal cytoreduction to ≤1 cm disease has repeatedly been shown to be associated with improved survival.

Diaphragm involvement was considered one of the most frequent obstacles to achieving optimal cytoreduction. The right diaphragm is more frequently and extensively involved than the left diaphragm; however, bilateral involvement is not uncommon. Various studies have advocated and reported the feasibility of diaphragmatic surgery in achieving optimal cytoreduction.

Sometimes, depending on extent of the disease, the diaphragm involvement could be massive and often the resection of the muscle with access to pleural cavity is necessary. Allegedly, entering the pleural cavity increases the morbidity of the procedure.

Extensive upper abdominal surgery involving diaphragmatic peritonectomy/resection and liver mobilization may both contribute to the development of symptomatic pleural effusions.

The aim of the study is to value the impact of diaphragmatic surgery in post-operative complications using a specific score (DRS). The other aim is to asses a correct management of intra-operatory thoracic drain position after diaphragmatic surgery. All parameter that could influence the post-operative outcomes as (EBL,BMI, OT, SCS) are recorded.

The study was approved by Ethical Committee of Fondazione Policlinico Gemelli Hospital (prot n. 9078/18).

The study is a superiority randomized clinical trial to investigate the role of intra-operative chest tube in the large (\> 5 cm) diaphragmatic peritonectomy/resection in the ovarian cancer debulking. Calculation of sample size for the analysis of the primary end-point (major pleural effusion) was based on literature results reporting a rate of moderate/severe early peri-operative pleural effusion between 54% and 23% when a large (\> 5 cm) diaphragmatic resection is performed. A sample size of 88 patients was required in order to provide 80% power of detecting a reduction of 60% of moderate/severe pleural effusion in PDS with large diaphragmatic resection when intra-operative chest tube was inserted (overall rate 22%) (two-tailed α =0.05, drop-out 5%).

Sample size is composed by 44 Patients affected by advanced stage ovarian cancer, meeting inclusion criteria, undergo diaphragmatic surgery followed by intra-operatory thoracic drain position and 44 patients with same characteristics undergo to diaphragmatic surgery without intra-operatory thoracic drain position. Both groups are compared in terms of incidence of post-operative complications (especially pleural effusion, pneumothorax, respiratory disease). Secondary endpoints are the evaluation of surgical outcomes and clinical outcomes in terms hospital stay, procedures and radiologic examinations required. All patients are adequately informed and inserted in the study only after having read and signed an informed consent. Diagnostic, clinical and surgical data of each patient are prospectively recorded.

Surgical procedures consist of surgical standard cytoreduction, performed for all cases of advanced stage ovarian cancer disease. The procedures performed depending on disease spread.

The diaphragmatic procedures, depending on the disease infiltration can consists of superficial peritonectomy, deep peritonectomy (until muscular layer) or diaphragmatic resection. Considering the randomization, if required, a thoracic drain tube 24 Fr. is positioned. A post-operative chest X-Ray is performed on all cases.

At the end of the procedure, a schedule is compiled with intraoperative data.

Post-operative examinations are follows:

* Chest X-Ray (2 h post-op)
* Chest X-Ray (day 1)
* Chest X-Ray (if required, depending of clinical indications)
* Thoracic US scan evaluation before discharge
* Thoracic US scan evaluation 10 days after discharge
* Radiological examinations (if required, depending of clinical indications)

All clinical and histologic data will be recorded prospectively using an electronic database.

Patients affected by advanced stage ovarian cancer with diaphragmatic involvement. When diaphragmatic resection is performed the patients are randomized to proceed with chest drain positioning or not

The investigator check the random list only when the patients is enrolled.

Diaphragmatic Resection And Gynecological Ovarian Neoplasm

The time to start chemotherapy is fundamental from oncological point of view. The ideal time to start chemotherapy treatment should exceed 40 days after surgery.

The data measured are

- time between surgery and first chemotherapy cycle

The intra operative blood loss is often related to the complexity of procedure and consequently to post-operative complications

The data measured are:

- EBL (ml)

The Operative time is often related to the complexity of procedure and consequently to post-operative complications

The data measured are:

- Operative time (minutes)

The diaphragmatic surgery is often related to post-operative complication. The most common complication is pleural effusion. This condition contribute to decrease the clinical outcomes causing increase of hospitalization and necessity medical or surgical treatment.

The main outcome is to asses a correct management of intra-operatory thoracic drain position after diaphragmatic surgery.

The outcomes measured are:

- Incidence of post-operatory pleural effusion detected by chest RX measuring pleural fluid collection (cm)

Catholic University of the Sacred Heart

Head of Department of Women's and Children's Health, Policlinico Agostino Gemelli Foundation University Hospital, Rome, Italy

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Esophageal Neoplasms

Postoperative Complications

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach

Ivor-Lewis Esophagectomy

Esophagectomy through Left Side Thoracotomy

Sweet Esophagectomy

Longqi Chen, MD, PhD

Yidan Lin, MD, PhD

Worldwide, esophageal cancer is the 6th most common cause of cancer-related death. Currently curative resection remains the cornerstone of the therapy. Despite advances in anesthesia, operative techniques and postoperative management, postoperative pulmonary complications (PPCs) occur frequently accounting for about 30% of all postoperative complications. Most importantly, PPCs have much been associated with postoperative mortality. The diaphragm is the most important respiratory muscle and its respiratory function would be inevitably damaged when esophagectomy is performed through the left posterolateral thoracotomy (Sweet procedure) because the diaphragm must be dissected for the purpose of stomach moralization. Meanwhile, Ivor-Lewis approach may effectively avoid diaphragm injury because the stomach can be managed through a laparotomy whereas an additional abdomen incision is needed. Both procedures are routinely used in practice when surgically managing esophageal cancer. The investigators hypothesize that Ivor-Lewis procedure might be superior to the left-thoracotomy route during esophagectomy in preventing PPCs.

Background:

Esophageal cancer is a common malignant tumor in China and worldwide with poor prognosis. Although the surgical resection combined with adjuvant therapy constitutes the mainstay of the treatment the esophagectomy-associated complications are still life-threatening. Postoperative pulmonary complications (PPCs), including pulmonary infection, atelectasis, edema and ARDS (acute respiratory distress syndrome) are the leading causes of the eventful postoperative episodes.

The diaphragm is the well known essential respiratory muscle whose normal function guarantees more than 30% of pulmonary function. Esophagectomy through left thoracotomy would inevitably cut off the left diaphragm for the abdominal procedure and thus greatly damage the diaphragmatic function. It has been assumed that Ivor-Lewis esophagectomy would save the pulmonary function to a great extent by retaining the intact diaphragm but the addition of a laparotomy would be unavoidable. However, this hypothesis has not been confirmed by any randomized controlled trial with adequate operation volume. At present, a large part of thoracic surgeons, for example in China, still prefer esophagectomy through Sweet approach believing that it is less traumatic. So far, there is presently no convincing evidence to guide the esophagectomy approach selection on the aspect of prevention of PPCs.

Objectives:

1. To compare the PPCs rates after Ivor-Lewis esophagectomy and Sweet esophagectomy
2. To compare the degrees of diaphragm function deficiencies between two groups.
3. To compare the pulmonary function results between two groups
4. To compare the degrees of gastric emptying between two groups

Diagnostic Criteria for PPCs: any one of the followings and not because of anastomotic leak, massive pleural effusion and non-pulmonary origin infection:

1. postoperative hypoxemia (PaO2≤ 60mmHg and/or PaCO2≥ 50mmHg) or dyspnea
2. transfer to intensive care unit due to hypoxemia or dyspnea
3. purulent pulmonary secretions requiring bronchoscopic suction
4. dependence on oxygen mask or nasal tube for more than 5 days
5. infiltrating or atelectasis in one pulmonary lobe or multiple segments identified by chest X-ray film or CT scan)
6. postoperative hiatal hernia associated pulmonary dysfunction
7. dependence on ventilator support for more than 48h

Degree of diaphragm function: The distance of diaphragmatic movement in centimeters

Pulmonary function measurement: FEV1, FVC and MMV

Gastric emptying function: Radioactivity remained at 15 minutes after ingestion of 100ml Tm99-labelled radioactive milk

Design:

Prospective randomized controlled trial.

Setting:

Thoracic Surgery Department, West China Hospital of Sichuan University, Chengdu, China

Patients and methods:

All patients with histologically confirmed esophageal carcinoma located at the middle or lower thoracic esophagus presenting to our hospital will be considered for the study

Termination criteria:

1. Intolerance of any of the treatment modality,
2. Development of PPCs
3. Development of any other severe complication, such as progressive bleeding, large pleural effusion, empyema
4. Death

Staging investigations will be standard and will include

1. Computed Tomography (CT) of Chest in all patients
2. Fibroesophagoscopy in all patients
3. Esophagogram by barium swallow in all patients
4. Endoscopic Ultrasonography (EUS) wherever possible Further investigation likes bronchoscopy, PET scan, or MRI will be applied if indicated.

Randomization:

Complete randomization will be done using a computer generated sheet. Randomization will be performed after confirming resectability of the primary tumor and enlarged lymph nodes.

All surgeries will be performed under general anesthesia with epidural analgesia. The surgery will be performed either by Dr. Longqi Chen or Dr. Yidan Lin who is the faculty and professor of the thoracic surgery department of West China Hospital. Thoracic esophageal mobilization and mediastinal lymphadenectomy will be done by open thoracotomy. Stomach dissection and gastric tube making will be done either through the left diaphragm incision when left thoracotomy is applied or through the laparotomy when Ivor-Lewis approach is applied. Operative time, blood loss, blood product replacement and all intraoperative details will be recorded in the proforma. Patients will be shifted postoperatively to the intensive care unit (ICU) for observation and subsequently to the recovery or high dependency ward once stabilized. Postoperative details including period of postoperative ventilation, hemorrhage, pulmonary and cardiac complications, arrhythmias, thoracic duct leak, anastomotic leak, wound infection and recurrent laryngeal nerve paresis or palsy will be recorded. Postoperative mortality will be defined as 30-day mortality plus death before discharge after surgery. Patients will be started on oral feeds between the 8th and 10th day in the absence of an anastomotic leak. The total duration of ICU stay and hospital stay will also be recorded.

Sample size:

The sample size considering an improvement of morbidity of sever pulmonary complications from 15% to 5% will be 280 patients (140 in each arm). The trial will aim at enrolling 320 patients in order to adjust for protocol violations. Interim analyses will be done when ½ (160 events) of the estimated events occur. We expect to complete accrual of patients in three years.

Follow up:

No follow up after discharge. The long-term pulmonary function is not the concern of this clinical trail.

Data management:

All collected data will be entered into a statistical software package for subsequent analysis

Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches

A Phase Ⅲ Study of Respiratory Complications Associated With Esophagectomy Through Either Ivor-Lewis or Sweet Approach for the Treatment of Middle or Lower Third Intrathoracic Esophageal Carcinoma

Sichuan University

West China Hospital / Longqi Chen, Professor

Dyspnea

Respiratory Aspiration

Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home.

Inspiratory muscle training will be performed using the POWERbreathe Plus IMT (POWERbreathe International Ltd., Warwickshire, UK), a commercially available inspiratory pressure threshold device. In this type of training, airflow is occluded until the generated inspiratory pressure reaches the predetermined threshold, which can be set at increments of 8 cm H2O.

During the first week of training, the target intensity will be set at 50% of baseline maximal inspiratory pressure (MIP.) During the second week, the target intensity will be set at 60% of baseline MIP. Beginning at the third week and for the remainder of the training program, the target intensity will be set at 75% of the participant's baseline MIP. The target volume will be 5 sets of 6 breaths per day (total of 30 breaths per day), separated by 1-minute rest breaks between sets. The frequency of training will be 5 days per week, for a duration of 6 weeks.

POWERbreathe Plus IMT

Martina Miller

Simon Ho

The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in childhood cancer survivors.

During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Diaphragm Structure and Function in Childhood Cancer Survivors

Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Childhood Cancer Survivors (2373GCCC)

Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol

Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol

Maximal pressure generated during an inspiratory maneuver, representing inspiratory muscle strength

Thickness of the diaphragm muscle measured by noninvasive ultrasound imaging

Ratio of ventilation to carbon dioxide production (VE/VCO2) during steady-state walking, representing ventilatory drive during exercise

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diaphragmatic Resection And Gynecological Ovarian Neoplasm	NCT03543462	Ovarian Cancer	thoracic Drain ...	18 Years - 80 Years	Catholic University of the Sacred Heart
Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches	NCT01053182	Esophageal Canc... Postoperative C... Diaphragm Pulmonary Funct...	Ivor-Lewis Esop... Sweet Esophagec...	18 Years - 70 Years	Sichuan University
Diaphragm Structure and Function in Childhood Cancer Survivors	NCT06205251	Childhood Cance... Cancer Survivor...	POWERbreathe Pl...	6 Years - 12 Years	University of Maryland, Baltimore
Diaphragmatic Resection And Gynecological Ovarian Neoplasm	NCT03543462	Ovarian Cancer	thoracic Drain ...	18 Years - 80 Years	Catholic University of the Sacred Heart

Spots Global Cancer Trial Database for diaphragm

Every month we try and update this database with for diaphragm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for diaphragm

Every month we try and update this database with for diaphragm cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for diaphragm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.