Intra-operative Visual Examination at IDS (VIPER)

Can Intraoperative Visual Examination of Diaphragmatic Peritoneum be a Reliable Tool to Modulate the Extent of Interval Debulking Surgery in Advanced Ovarian Cancer? The VIPER (VIsual Peritoneal Evaluation of Residual Disease) Study

Complete disease removal has the greatest impact in the treatment of advanced ovarian cancer, both during primary debulking surgery (PDS) and interval debulking surgery (IDS), but, contrarily to PDS, no consensus exist on the interpretation of the absence of residual tumor at IDS. In addition, chemotherapy induces fibrotic changes that can hinder the surgeon's ability to properly assess the spread of abdominal disease. The aim of the study is to evaluate the accuracy of visual inspection compared to histopathological examination at the level of the diaphragmatic peritoneum in patients undergoing surgery after neoadjuvant chemotherapy.

Study Overview

• Status: Completed
• Conditions: Diaphragm Disease
• Intervention / Treatment: Other: histological examination

Detailed Description

All data of patients subjected to IDS between October 2016 and October 2019 with evidence of suspected or certain residual disease at the level of the right diaphragmatic peritoneum, at intra-operative evaluation have been collected. Diaphragmatic peritoneum was classified as negative, not-surely pathologic and certainly pathologic by the surgeon, and based on the surgeon's opinion, a diaphragmatic biopsy or peritonectomy was then performed. The definition of not-surely pathologic diaphragmatic peritoneum was given in association with the presence of flat dyschromic areas, while the definition of certainly pathological diaphragmatic peritoneum was given when isolated or confluent thick nodules were visualized at the intra-operative inspection. Residual disease was indicated at the end of each intervention and classified as no residual disease (RD=0, complete cytoreduction), less than 1 centimeter (RD </= 1 cm, optimal cytoreduction) or more than 1 cm (RD > 1 cm, sub-optimal cytoreduction).

Pathological specimens' results were also divided in negative (no evidence of disease), microscopic evidence of residual disease (</= 3 mm) or macroscopic signs of residual disease (> 3 mm). Microscopic and macroscopic disease were both considered as positive for residual disease.

General early post-operative complications (arising within 30 days from surgery), and complications related to diaphragmatic peritonectomy, as post-operative pleural effusion, were classified using the extended Clavien-Dindo classification of surgical complications.

The primary end-point of the study was to evaluate the accuracy, sensitivity and specificity of the visual inspection compared to histopathological examination, at the level of the right diaphragmatic peritoneum, in patients subjected to IDS.

The secondary endpoints were to evaluate the rate of early postoperative complications related to diaphragmatic peritonectomy and assess whether this procedure may delay the re-start of post-operative chemotherapy.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00168
      • Fondazione Policlinico Universitario A. Gemelli, IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with histology proven biopsy of epithelial ovarian, fallopian or peritoneal cancer (FIGO stage III C - IV B), judged suitable for IDS by clinicians, with evidence of suspected or certain residual disease at the level of the right diaphragmatic peritoneum, at intraoperative evaluation.

Description

Inclusion Criteria:

• patients with histology proven biopsy of epithelial ovarian, fallopian or peritoneal cancer (FIGO stage III C - IV B), judged suitable for IDS by clinicians, with evidence of suspected or certain residual disease at the level of the right diaphragmatic peritoneum, at intraoperative evaluation.

Exclusion Criteria:

• Patients with no evidence of diaphragmatic disease during IDS, and who therefore did not undergo diaphragmatic peritonectomy or biopsy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with not-surely pathologic diaphragmatic peritoneum; The definition of not-surely pathologic diaphragmatic peritoneum was given in association with the presence of flat dyschromic areas.	Other: histological examination; Patients were classified in two groups based on the surgeon's visual examination of the right diaphragmatic peritoneum. The accuracy of visual examination has been assessed comparing surgeon's opinions to histological examination
Patients with certainly pathologic diaphragmatic peritoneum; The definition of certainly pathological diaphragmatic peritoneum was given when isolated or confluent thick nodules were visualized at the intra-operative inspection.	Other: histological examination; Patients were classified in two groups based on the surgeon's visual examination of the right diaphragmatic peritoneum. The accuracy of visual examination has been assessed comparing surgeon's opinions to histological examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	to evaluate the accuracy of the visual examination compared to histopathological examination, at the level of the right diaphragmatic peritoneum, in patients subjected to IDS	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications	to evaluate the rate of early postoperative complications related to diaphragmatic peritonectomy	up to 30 days after surgery

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Barbara Costantini, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 21, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: ovarian cancer; interval debulking surgery; visual examination
• Other Study ID Numbers: DIPUSVSP-03-02-2033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No