IPC Status as a Surgical Quality Marker in Rectal Cancer Surgery

Rectal Cancer Clinical Trial

Official title:

IPC Status as a Surgical Quality Marker in Rectal Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02081547
• Other study ID #: IPC
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2012
• Last updated: March 5, 2014
• Start date: April 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2014
• Source: Uppsala University
• Contact: Maziar Hosseinali khani Nikberg, MD PhD
• Phone: +46 21 173000
• Email: maziar.nikberg[@]ltv.se
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Sweden	Mälarsjukhuset Eskilstuna	Eskilstuna
Sweden	Västmanlands sjukhus	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Kristensen AT, Wiig JN, Larsen SG, Giercksky KE, Ekstrøm 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. — View Citation

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. — View Citation

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.0b013e31 — View Citation

Skipper D, Cooper AJ, Marston JE, Taylor I. Exfoliated cells and in vitro growth in colorectal cancer. Br J Surg. 1987 Nov;74(11):1049-52. — View Citation

Uras C, Altinkaya E, Yardimci H, Göksel S, Yavuz N, Kaptanoglu L, Akçal 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	TME quality	The surgeon grades the mesorectal completeness in a four grade scale.	Day 1	No
Secondary	local recurrence	occurence of local recurrence.	3-5 years after operation	No
Secondary	Survival		after 3-5 years	No