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Diaphragmatic Resection And Gynecological Ovarian Neoplasm (DRAGON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543462
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart

Tracking Information
First Submitted Date  ICMJE March 21, 2018
First Posted Date  ICMJE June 1, 2018
Last Update Posted Date June 1, 2018
Actual Study Start Date  ICMJE March 20, 2018
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
Measurement of incidence of pleural effusion after diaphragmatic resection and useful of chest drain to prevent pleural effusion and consequent respiratory symptoms as dyspnea. [ Time Frame: 30 days ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 18, 2018)
  • Time to start chemotherapy [ Time Frame: 40 Days ]
    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
  • Estimated blood loss [ Time Frame: 1 Day ]
    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)
  • Operative time [ Time Frame: 1 Day ]
    The Operative time is often related to the complexity of procedure and consequently to post-operative complications The data measured are: - Operative time (minutes)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Diaphragmatic Resection And Gynecological Ovarian Neoplasm
Official Title  ICMJE Diaphragmatic Resection And Gynecological Ovarian Neoplasm
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Investigator)
Masking Description:
The investigator check the random list only when the patients is enrolled.
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Device: thoracic Drain Tube 24 Fr.
Positioning of Thoracic Drain after diaphragmatic resection and consequently diaphragmatic repair
Study Arms  ICMJE
  • Sham Comparator: Arm A: Chest tube positioning YES
    Patients enrolled for chest tube positioning
    Intervention: Device: thoracic Drain Tube 24 Fr.
  • No Intervention: Arm B: Chest tube positioning NO
    Patients enrolled for diaphragm closure without chest tube positioning
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2018)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2019
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stefano Cianci, M.D. 00393336598361 stefano.cianci@policlinicogemelli.it
Contact: Stefano Cianci, M.D. 3336598361 stefano.cianci@policlinicogemelli.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03543462
Other Study ID Numbers  ICMJE D.R.A.G.O.N. ID. 1963
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Prof. Giovanni Scambia, Catholic University of the Sacred Heart
Study Sponsor  ICMJE Catholic University of the Sacred Heart
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefano Cianci, M.D. Fondazione Policlinico Agostino Gemelli
PRS Account Catholic University of the Sacred Heart
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP