Clinical trial · Observational
IPC Status as a Surgical Quality Marker in Rectal Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- IPC status
- description
- presence of cancer cells.
Primary outcomes (1)
- measure
- IPC status
- timeFrame
- One year
- description
- 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).
Secondary outcomes (3)
- measure
- TME quality
- timeFrame
- Day 1
- description
- The surgeon grades the mesorectal completeness in a four grade scale.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- RESULTSkipper 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. doi: 10.1002/bjs.1800741130. PMID 3690235
- RESULTKristensen 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
- RESULTUras 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
- RESULTMaeda 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
- RESULTNoura 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