Clinical trial NCT03543462: Diaphragmatic Resection And Gynecological Ovarian Neoplasm
Official title: Diaphragmatic Resection And Gynecological Ovarian Neoplasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Diaphragm
Chest Drain
Diaphragmatic Resection
Pleural Effusion
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 \< 80 years
* Patient's informed consent
* American Society of Anesthesiologists: \< class III or IV
* No actual pregnancies or pelvic inflammatory disease (P.I.D.)
* BMI \< 40
* Macroscopic diaphragmatic disease infiltration (mono lateral)
* Grade IIIA-IV diaphragmatic resection score
* Advanced stage ovarian cancer (stage III-IV)
* Primary diagnosis, interval debulking surgery, recurrent disease
* All histotype included

Exclusion Criteria:

* Actual pregnancies or P.I.D
* BMI \> 40
* Pulmonary or thoracic preoperatory disease
* Preoperative pleural effusion
* Residual thoracic disease after surgery
* Residual diaphragmatic disease after surgery

Primary outcomes:
measure: Measurement of incidence of pleural effusion after diaphragmatic resection and useful of chest drain to prevent pleural effusion and consequent respiratory symptoms as dyspnea.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: Time to start chemotherapy
timeFrame: 40 Days
measure: Estimated blood loss
timeFrame: 1 Day
measure: Operative time
timeFrame: 1 Day
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli
state: Rome
Study officials:
affiliation: Fondazione Policlinico Agostino Gemelli
name: Stefano Cianci, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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