Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients who underwent an open approach to pelvic exenteration

Patients who underwent a laparoscopic approach to pelvic exenteration

Patients who underwent a robotically-assisted pelvic exenteration

Matthew Fahy, MD

Michael Kelly, MD

Des Winter, MD

Desmond Winter, MD

Minimally-invasive surgery (MIS) techniques have revolutionised the approach to rectal cancer surgery. With increasing experience, surgeons have began to utilise these platforms increasingly in the context of pelvic exenteration (PE). This observational retrospective review plans to assess the volume of PE being performed on a global basis and to assess the comparative outcomes associated with each technique in order to assess the optimal approach to radical pelvic surgery.

Pelvic exenteration (extended pelvic multi-visceral resection) is a radical procedure that offers potential long-term cure in appropriately selected cases of locally advanced and recurrent pelvic cancers. It was first described by Alexander Brunschwig in 1948 as a viable palliative option for advanced gynaecological cancer. However, over the last 70 years, changes in surgical oncology practices have seen its role extended to include other advanced non-gynaecological cancers (locally advanced colorectal, urological, and sarcomatous neoplasms).

Although these procedures pose a significant challenge for the operating surgeon, improved surgical techniques, technology, and reconstructive options have facilitated more radical resections. Despite improved surgical options, patients still have considerable post-operative morbidity and negative impact to quality of life. However, non-surgical management options result in poor prognosis with only 3% survival at five-years. Pelvic exenteration in appropriately-selected patients offers the only hope of long-term survival.

Over the last few decades with improved perioperative management and better surgical techniques, more aggressive visceral, soft tissue and bony resections are performed. The development of minimally invasive surgery (MIS) platforms has also evolved substantially, especially regarding pelvic surgery. There are some recent sporadic (low-volume) reports highlighting the potential role for MIS exenterative surgery, however many reports have been heterogeneous and single-centre. The aim of this retrospective review is to compare the volume, disease characteristics and surgical outcomes between open, laparoscopic and robotic pelvic exenterations, and to assess the initial experience of MIS platforms in multiple specialist centres worldwide.

A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Completeness of the surgical resection (R0, R1 or R2)

Time from first incision to skin closure (minutes)

Need to convert from robotic or laparoscopic to open procedure

Frequency of post-operative complication, as measured by the Clavien-Dindo scale

Duration of stay in hospital post-procedure

Quantity of analgesia consumed, primarily opioid analgesia measured in morphine equivalents

Time to passage of flatus or bowel motion

St Vincent's University Hospital, Ireland

Professor Desmond C Winter

Symptoms and General Pathology

Carcinoma

Adenocarcinoma

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

Currently there are no validated criteria or guidelines for judging whether advanced primary or recurrent colorectal cancer can be successfully removed and for selecting which patients should undergo this form of more radical surgery as is exenterative surgery. We are proposing that by validating the detailed evaluation of imaging of the tumour distribution within the pelvis using a new radiological staging classification, this will enable clear selection criteria to be established and will improve surgical planning.

New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery

Caroline Martin

Syvella Ellis

Arne Solbakken

Kjersti Flatmark

Ian Jenkins

Pooja Datt

Chris Cunningham

Madeleine Thyssen

Cordelia Grant

Christos Kontovounisios, MD

Gina Dr Brown, MD

All patients with recurrent colorectal cancer in the pelvis are eligible. The original primary tumour staging scans and resected surgical specimen needs to be available. Patients' recurrence will be staged using our proposed MRI classification. We will be assessing the original primary staging scans and histopathology to learn about risk factors for recurrence. We will record treatment for the recurrence, and patients will be followed up for three years.

A prospective and retrospective cohort study to improve surgical and treatment planning using an imaging assessment proforma of advanced and recurrent colorectal cancers. This involves the implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

Beyond TME Origins

Investigating the Origins of Pelvic Recurrence in Colorectal Cancer

An increase of 20% in R0 resection (from 55% to 75%) for locally recurrent rectal cancers with the use of the proposed staging system

Correlation of baseline and post treatment prognostic factors on imaging and pathology against type of recurrence.

Proportion of patients with survival \>12mths according to type of recurrence as described on MRI

Proportion of patients with survival \>12mths according to compartment(s) of recurrence as described on MRI

Quality of life assessed using EORTC QLQ-C30

The number of compartments predicted as involved on MRI against the number of compartments reported on the corresponding pathology specimens

Kappa agreement between paired radiologists for type of recurrence

Healthcare costs using NHS Reference Costs combined with health resource utilization and QoL data

Correlation of dose, type and distribution of radiotherapy against anatomic sites and aetiology of recurrence as seen on MRI

Pelican Cancer Foundation

Imperial College London

PELVIC EXENTERATION

ANTONIA CARLA TESTA, PROF

NICOLO' DR BIZZARRI

ANTONIA CARLA Pr TESTA

Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool.

All consecutive patients who are planned to undergo pelvic exenteration or laterally extended pelvic resection at Policlinico Agostino Gemelli IRCCS, will undergo ultrasound scan at the time of the pre-operative anesthetic assessment or the day before the planned surgery. A pre-defined case report form (CRF) will be filled by the ultrasound examiner. The ultrasound characteristics will be compared with the final histology (considered the referral standard).

The ultrasound examinations will be carried out using high-end ultrasound equipment. The frequency of the vaginal probes varied between 5.0 and 9.0 MHz. All examinations will be performed by a specialist obstetrics and gynecology with expertise in gynecologic oncology ultrasound scan. A subjective semi-quantitative assessment of the amount of blood flow within the examined lesion will be made (color score): a score of 1 was recorded when no blood flow could be found; 2 when only minimal/moderate flow could be detected; 3 when very strong blood-flow signals were present.

All patients will undergo pre-operative MRI scan and PET/CT scan. Pelvic exenteration and laterally-extended pelvic resection will be performed with the aim to remove en bloc the recurrent or persistent disease with a free-of-tumor margin.

Pelvic Exenteration and Laterally Extended Pelvic Resection

Accuracy of Ultrasound Scan in Patients Undergoing Pelvic Exenteration and Laterally Extended Pelvic Resection

The accuracy of US in the assessment of pelvic structures involvement in recurrent/persistent gynecologic tumors with disease limited to the pelvis.

To compare accuracy of US with the accuracy of MRI scan using histology as standard.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Pelvic Neoplasms

Disease Attributes

Adult patients (\>18 years) with locally advanced pelvic cancer that require pelvic exenteration considered eligible for robot- assisted minimally invasive surgery by the respective multidisciplinary teams

Patients with locally advanced pelvic cancer that require pelvic exenteration considered eligble, are operated minimmally invasive robot-assisted

robot-assisted total pelvic exenteration

Ebbe B Thorgersen, MD PhD

Arne M Solbakken, MD

The Radium Hospital Oslo University Hospital Estimated date of first patient enrolled: 3rd quarter 2021 Anticipated recruitment period: 4 years Estimated date of last patient completed: 4th quarter 2025

Locally advanced pelvic cancer that requires total pelvic exenteration

Expected study-specific follow-up period per patient: 5 years according to standard follow-up for this patient group

Primary endpoint:

R0 resection rate (circumferential resection margin \>1mm)

Secondary endpoints:

Rate of conversion to open surgery, peri- and postoperative complications, hospital length of stay, wound healing at 3 months follow-up, Quality of Life measured by EORTC Quality of Life Questionnaire C-30 preoperatively, at 3 months and 3 year follow-ups, disease-free survival, overall survival.

Diagnosis specific endpoints.

Open label observational study.

Pelvic exenteration for locally advanced rectal cancer (LARC) and locally advanced sigmoid cancer LARC includes tumours threatening the mesorectal fascia or invading adjacent organs and structures (9). Locally advanced sigmoid cancer is defined as tumors extending through the colon wall with perforation and/or invasion of adjacent organs or structures (10). Surgical removal is the standard curative approach for these tumours, and achievement of complete tumour removal, or R0 resection, is prognostically important. The Residual tumour (R) classification defines R0 resection as having \> 1 mm margin between the tumour and surrounding normal tissue, R1 resection as ≤ 1 mm margin, and R2 as local macroscopic residual tumour after resection (11). If R0 resection is achieved, the outcome for the patient is dramatically superior compared to when resection is incomplete. In a large study of 1291 LARC cases, the overall survival was 43 months in R0 cases compared to 21 months if R1 resection was achieved (12).

Neoadjuvant therapy including chemotherapy and (chemo) radiotherapy ((C) RT) has resulted in improved local control (13), presumably by increasing the rate of complete surgical tumour removal (14), when the patient is operated. Total radiation dose towards the pelvis are usually 25-50 Gy, often with concomitant fluoropyrimidine-based chemotherapy. Although the neoadjuvant radiotherapy improves prognosis (14), it also imposes challenges. The surgery itself might be difficult because of edema and fibrosis resulting in potentially involved margins, and the healing after surgery is impaired leading to increased postoperative morbidity. This holds true for all tumours in the pelvis that receive radiotherapy before surgery. Despite neoadjuvant therapy, tumours still often require resection of neighboring organs in order to achieve R0-resection.

First described in 1948, total pelvic exenteration can be defined as the removal of the bladder, removal of the prostate (in males), removal of the uterus or the vaginal vault and partial or total resection of the vagina (in females), and the removal of the rectum with or without the anus (15). Total pelvic exenteration is extensive surgery with reconstructions that include two stomas. Locally advanced rectal cancers and locally advanced sigmoid cancers with multiorgan involvement e.g. rectal cancer invading the prostate or the urinary bladder are candidates for total pelvic exenteration.

Pelvic exenteration for recurrent cervical and endometrial cancer previously treated with radiochemotherapy and selected cases of primary advanced vulva cancer For patients with gynecologic cancer, pelvic exenteration is sometimes the only available curative treatment. Particularly patients with recurrent cervical and endometrial cancer previously treated with chemoradiation are considered candidates for pelvic exenteration. Selected cases of primary advanced vulva cancer are also considered for more extensive pelvic surgery such as modified anterior or posterior pelvic exenteration. In Norway, pelvic exenteration for recurrent cervical cancer is centralized to the Department for Gynecologic Oncology at the Oslo University Hospital and annually, approximately 10-15 patients are treated with total pelvic exenteration. An ongoing project in our Institution evaluating the clinical outcome of 95 patients treated with open pelvic exenteration for one of the above mentioned diagnoses revealed that about 50 % of the patients developed at least one severe complication (grade 3 or above according to the contracted Accordion severity grading system of surgical complications). 87% had negative surgical margins on final histology, but after median follow up time of 3.2 years, 59% of the patients had relapsed. About a third of those were central/pelvic recurrences. The high complication rate warrants further improvement of the surgical technique and minimally invasive surgery has emerged as a promising approach for selected patients (16, 17). Recently, case reports utilizing laparoscopic robot-assisted surgery have been published (18, 19). The reports indicate satisfactory oncological results and less surgical morbidity compared to open surgery.

In many of the case reports on gynecological exenterations the reconstruction of the urinary tract is done extra-corporally. In our Institution, robot-assisted intra-corporal urinary diversion is well established. Thus, the robotic approach for pelvic exenterations is attractive and feasible in our multidisciplinary surgical group.

Study design Open label observational study. Study objectives This study is a feasibility study of laparoscopic robot-assisted total pelvic exenteration for pelvic cancers.

Feasibility will be assessed through:

1. Determining the R0 resection rate in included study patients
2. Assessment of conversion rate to open surgery
3. Assessment of perioperative and postoperative complications

Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers

R0 resection in oncological surgery means resection with circumferential margin \>1mm from the tumour. R0 resection is considered as an important predictor for outcome.

a quality indicator and feasibility measure for the procedure

Any complications within the first 90 days after surgery

How long the patient stay in Hospital after surgery

If the patient have any recurrent disease

Quality of Life measured before and on specific controles postoperative

Oslo University Hospital

Principal investigator

Norman Galbraith, PhD MRCS

Colin Steele, PhD FRCS

Norman Galbraith, MSc PhD MRCS

Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.

Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.

Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.

Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study..

Not currently, but in the future, plans to study circulating immune cell/cytokine measurements, ctDNA, peritoneal macrophage/neutrophils, and existing protocols for biobanking of tumour samples/organoids

Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

Glasgow Royal Infirmary

NES/CSO Clinical Lecturer in Surgery

Behaviors and Mental Disorders

Wounds and Injuries

Anxiety Disorders

Depressive Disorder

Depression

Cognitive Dysfunction

Hyperthermia

Fever

Quality of Life

Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases

Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder

Rogini Balachandran, MD

Lene H Iversen, Professor

Per Nilssons, Ass. Professor

Marie-Louise Lydrup, Ass. Professor

The purpose of this study is to describe type and extent of psychological distress (adverse effects) in patients undergoing surgery for colorectal cancer with peritoneal metastases and after surgery for colorectal cancer with involvement of the urinary bladder.

After being informed about the study all patients giving written informed consent will be distributed a questionnaire asking questions on depression, anxiety, self-reported cognitive issues, sleep issues, quality of life and 'fear of cancer recurrence'. All these aspects will be investigated using validated questionnaires.

Once the investigators have the preliminary results (type and extent of psychological distress developed after CRS+HIPEC or PE) the investigators plan to conduct a workshop. In this workshop experts in different areas regarding psychological distress, project leaders, professor from the 'National Center of Late Adverse Effects after Cancer in Pelvic Organs' (Denmark) and patients will participate. With the input of experts and patients, a treatment strategy will be developed, and also an assessment will be made concerning which patients are likely to benefit from treatment by these experts, and which patients could potentially benefit from counselling by their general practitioner or via self-helping tools at home. The investigators plan to conduct this workshop autumn 2021 and start counselling spring 2022.

Psychological distREsS hipEc oR pelVic Exenteration

Psychological Distress in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration

Descriptive analysis will be done using the following questionnaire: PHQ-9 (patient health questionnaire)

Descriptive analysis will be done using the following questionnaire: GAD-7 (general anxiety disorder)

Descriptive analysis will be done using following the questionnaire: Items regarding cognitive functioning from the EORTC item library

Descriptive analysis will be done using following the questionnaire: ISI (insomnia sleep index)

Descriptive analysis will be done using following the questionnaire: FACIT V4 (fatigue scale)

Descriptive analysis will be done using following the questionnaire: Fear of cancer recurrence - SF

Univariate and multivariate regression analysis will be performed to identify potential risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery	NCT04948762	Pelvic Exentera... Advanced Pelvic... Locally Advance...		18 Years -	St Vincent's University Hospital, Ireland
Beyond TME Origins	NCT02292641	Neoplasms Adenocarcinoma Carcinoma	New Radiologica...	16 Years -	Imperial College London
Pelvic Exenteration and Laterally Extended Pelvic Resection	NCT06278610	Gynecologic Can... Surgical Proced...	PELVIC EXENTERA...	-	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers	NCT05186493	Locally Advance...	robot-assisted ...	18 Years -	Oslo University Hospital
Advanced Pelvic Surgical Oncology Database - Prospective Observational Study	NCT05696002	Rectal Cancer Pelvic Cancer Gynecologic Can... Colon Cancer		-	Glasgow Royal Infirmary
Psychological distREsS hipEc oR pelVic Exenteration	NCT04956107	Colo-rectal Can...		18 Years -	University of Aarhus

Spots Global Cancer Trial Database for pelvic exenteration