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IPC Status as a Surgical Quality Marker in Rectal Cancer Surgery

IPC Status as a Surgical Quality Marker in Rectal Cancer Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02081547
Enrollment
50
Registered
2014-03-07
Start date
2012-04-30
Completion date
2014-09-30
Last updated
2014-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

rectal carcinoma, recurrence, pathology, cytology, free cancer cells, survival

Brief summary

Risk of local recurrence after rectal surgery is nationally 8% after curative surgery to 5%. Local recurrence rate after curative surgery varies between 3-7% in the variety of regions in the country. It is well known that the surgical technique total mesorectal excision (TME) has led to improved prognosis after rectal cancer surgery. TME surgery is difficult to perform and different factors affect the quality of TME preparations. Injuries in mesorectal fascia has been reported in up to 20% of patients who underwent TME surgery and most surgeons agree that this may be important for recurrences. However, it is unclear to what extent a damaged mesorectal fascia can be related to a worsening of prognosis in patients with rectal cancer. Adjuvant oncological treatment in form of chemotherapy after surgery, is offers patients with unfavorable tumors based on the pathological examination. Patients with favorable tumors (less advanced) are not offered chemotherapy, even if the surgical technique was not optimal, ie. that there is damage in the mesorectal fascia, as evidence for this is lacking. The presence of intraperitoneal cancer cells (IPC) is related to histopathological tumor stage of colorectal cancer. Incidence of IPC of intraperitoneal tumors (rectal cancer patients with tumors below the peritoneal reflection) is unclear. Assessment of IPC status with cytology and immunohistochemistry is technically easy and could after TME surgery identify those patients who have an increased risk of tumor recurrence. In a positive IPC status, the patient would possibly benefit from either postoperative radiotherapy if the patient did not receive preoperative therapy, or postoperative oncological chemotherapy. Tumour cells may be lysed in sterile water, and some surgeons rinse the abdominal cavity and the bowel distally to the tumour. Neither rinsing the abdomen or rectum in colorectal cancer is routinely occurring and the clinical benefit has not been established. The value of rinsing the abdomen after TME-surgery could also be studied by IPC status. The study hypothesis is that the IPC status is dependent on the surgical quality of the specimen after TME-surgery in rectal cancer patients, and its presence leads to increased risk of local recurrence.

Interventions

None listed

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* rectal cancer patients that are going to be operated with bowel resection * control patients (10 patients) - patients with different conditions that are going to be operated.

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
IPC statusOne yearOccurence of cancer cells per 100 mesothelial cell for the sample taken at the start of the surgery (sample 1). After completion of the TME-Surgery (sample 2) and after rinsing the abdomen (sample 3). The outcome will be assessed and presented when all patients are included (approximately dec 2013).

Secondary

MeasureTime frameDescription
TME qualityDay 1The surgeon grades the mesorectal completeness in a four grade scale.
local recurrence3-5 years after operationoccurence of local recurrence.
Survivalafter 3-5 years

Countries

Sweden

Contacts

Primary ContactMaziar Hosseinali khani Nikberg, MD PhD
maziar.nikberg@ltv.se+46 21 173000
Backup Contactkennet Smedh, MD PhD
kenneth.smedh@ltv.se+46 21 173000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026