IPC Status as a Surgical Quality Marker in Rectal Cancer Surgery

NCT02081547 | Unknown

• 1 other identifier: IPC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Rectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• IPC status

  Occurence 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).

  One year

Secondary Outcomes (3)

• TME quality

  Day 1

• local recurrence

  3-5 years after operation

• Survival

  after 3-5 years

Study Arms (1)

IPC status

presence of cancer cells.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 patients with rectal cancer and 10 patients without rectal cancer that are operated.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (2)

Mälarsjukhuset Eskilstuna

Eskilstuna, 63188, Sweden

COMPLETED

Västmanlands sjukhus

Västerås, 72189, Sweden

RECRUITING

Related Publications (5)

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  PMID: 3690235 RESULT

• Kristensen AT, Wiig JN, Larsen SG, Giercksky KE, Ekstrom PO. Molecular detection (k-ras) of exfoliated tumour cells in the pelvis is a prognostic factor after resection of rectal cancer? BMC Cancer. 2008 Jul 27;8:213. doi: 10.1186/1471-2407-8-213.

  PMID: 18655729 RESULT

• Uras C, Altinkaya E, Yardimci H, Goksel S, Yavuz N, Kaptanoglu L, Akcal T. Peritoneal cytology in the determination of free tumour cells within the abdomen in colon cancer. Surg Oncol. 1996 Oct-Dec;5(5-6):259-63. doi: 10.1016/s0960-7404(96)80030-2.

  PMID: 9129139 RESULT

• Maeda K, Maruta M, Hanai T, Sato H, Horibe Y. Irrigation volume determines the efficacy of "rectal washout". Dis Colon Rectum. 2004 Oct;47(10):1706-10. doi: 10.1007/s10350-004-0659-z.

  PMID: 15540303 RESULT

• Noura S, Ohue M, Seki Y, Yano M, Ishikawa O, Kameyama M. Long-term prognostic value of conventional peritoneal lavage cytology in patients undergoing curative colorectal cancer resection. Dis Colon Rectum. 2009 Jul;52(7):1312-20. doi: 10.1007/DCR.0b013e3181a745a4.

  PMID: 19571710 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

250 ml NaCl is poured in the abdominal cavity 3 times during the operation and is collected for accurence of cancer cells with Haemathoxylin\&Eosin staining and immunohistochemistry. DNA sequencing is not performed.

MeSH Terms

Conditions

Rectal Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maziar Hosseinali khani, MD PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maziar Hosseinali khani Nikberg, MD PhD

CONTACT

+46 21 173000; maziar.nikberg@ltv.se

kennet Smedh, MD PhD

CONTACT

+46 21 173000; kenneth.smedh@ltv.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: March 7, 2014
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

SE (2)