Stents in malignant colorectal stenosis: a useful treatment option?

Andreas W. Berger, Ulm

JAMA Surgery 2017; 152:429-435

Importance

Colonic stenting was introduced for palliation of malignant large-bowel obstruction (MLBO) more than 20 years ago but remains controversial.

Objective

To compare outcomes after palliative stenting vs stoma creation in patients with MLBO requiring emergency management.

Design, setting and participants

This observational cohort study assessed 345 patients from New York State with an urgent or emergency admission to the hospital for obstruction secondary to colorectal cancer and who underwent stenting or stoma creation from October 1, 2009, through December 31, 2013. Patients were excluded if they underwent resection within 1 year of the index admission.

Main outcomes and measures

Primary outcomes included subsequent operation and readmission within 90-day and 1-year follow-up. Secondary outcomes were in-hospital death, major medical and surgical complications, length of stay, total charges, and discharge dispositions. Multivariable hierarchical analyses and propensity score matching were used to compare outcomes between the exposure groups.

Results

The cohort included 345 patients (mean [SD] age, 69.9 [14.4] years in the stoma group and 70.9 [16.8] years in the stent group; 87 men [50.3%] in the stoma group and 90 [52.3%] in the stent group; and 114 non-Hispanic white patients [65.9%] in the stoma group and 90 [52.3%] in the stent group). Most patients undergoing stenting were treated at high-volume (104 [60.5%]) vs medium-volume (42 [24.4%]) or low-volume (26 [15.1%]) hospitals (P < .001). Patients undergoing stenting were significantly less likely to experience prolonged length of stay (odds ratio [OR], 0.50; 95%CI, 0.26-0.97; P = .04), more likely to be discharged to their usual residence (OR, 0.14; 95%CI, 0.07-0.28; P < .001), and tended to have similar or fewer complications (major events: OR, 0.81; 95%CI, 0.30-2.18; P = .68; procedural complications: OR, 0.57; 95%CI, 0.11-1.22; P = .10). There was no significant difference between the groups in terms of 90-day and 1-year readmission to the hospitals (90 days: OR, 0.93; 95%CI, 0.49-1.78; P = .83; 1 year: OR, 0.72; 95%CI, 0.38-1.37; P = .30). Subsequent operation at 90 days was also not different between the groups (OR, 1.34; 95% CI, 0.26-6.89; P = .72), but there was a higher chance of subsequent operation at 1 year after the stenting procedure (OR, 2.93; 95%CI, 1.12-7.68; P = .03), with most subsequent operations being restenting.

Conclusions and relevance

In patients with MLBO and if resection is not part of the treatment plan, stenting is safe and improves the efficiency of care with obvious quality-of-life benefits. It should be offered at experienced centers, and patients should be counseled regarding increased risk of subsequent stenting within 1 year.

What you need to know about this paper

Colorectal carcinoma is the third most frequent tumor worldwide, with approximately 1.4 million new cases and 700,000 deaths per year [1]. It is estimated that 8–29% of patients with colorectal carcinoma have clinically evident malignant large-bowel obstruction (MLBO), which should prompt rapid therapeutic management [2]. It is also thought that curative resection is not possible in around one-third of patients with acute MLBO [3]. Traditionally, surgical management for acute MLBO involved stoma placement and/or resection, with a perioperative morbidity rate of up to 46% and a mortality rate of up to 28% for each procedure [4–7].

The first investigations on the value of self-expanding metal stents (SEMS) in the treatment of MLBO started in the early 1990s [8]. On the basis of that research, a number of studies over the last 10 years have explored the option of using SEMS in the treatment of MLBO. Despite initially good data on SEMS in the context of a palliative treatment approach, hopes were dashed by two randomized clinical studies that were prematurely terminated due to an unexpectedly high perforation rate [9,10]. However, a recent small study published in a respected journal reported good results in the early follow-up period, supporting the view that experienced endoscopists may be able to obtain good results. Nevertheless, the results are only available in abstract form, rather than as a full publication, and they consequently need to be interpreted with caution [11].

The state of the data and the recommendations for SEMS use in colorectal carcinoma patients with MLBO are still matters of controversy, and the outcome analyses in the various studies are methodologically very heterogeneous. The current ESGE guideline on the management of MLBO offers the following recommendations (cited from [12]):

1. Prophylactic stenting is not recommended. (Strong recommendation, low evidence level)
2. Surgery is the treatment of choice with curative intent for patients with malignant stenosis in the proximal colon. (Weak recommendation, low evidence level)
3. Stenting is an option for treatment with curative intent in patients with malignant left-sided stenosis, but a high rate of perioperative complications must be expected. (Weak recommendation, low evidence level)
4. SEMS is the preferred treatment approach for MLBO in the palliative setting. (Strong recommendation, high evidence level)
5. Covered and uncovered stents are equally effective. (High evidence level)
6. There are no general limitations in relation to the grade of the malignant obstruction (strong recommendation, low evidence level) or its length (weak recommendation, low evidence level).

The recent observational cohort study presented here included 345 patients with MLBO due to colorectal carcinoma (173 patients in the stoma group and 172 patients in the stent group) in the period from 2009 to 2013. The outcomes after 90 days and 1 year (primary end points) were analyzed. Secondary end points included hospital mortality and more severe medical and surgical complications. The study only included patients receiving palliative treatment for colorectal carcinoma. The data were obtained from a statewide database (the New York State Department of Health Statewide Planning and Research Cooperative System: all age groups, all payers).

Significantly fewer patients in the stent group died in hospital in comparison with the stoma group (11 [6.4%] vs. 22 [12.7%]; P = 0.05), and the patients in the stent group also received fewer transfusions in the postprocedure period (37 [21.5%] vs. 57 [32.9%]; P = 0.02). The patients in the stent group had not only a lower rate of parenteral nutrition (16 [9.3%] vs. 37 [17.9%]; P = 0.02), but also shorter hospital stays (median 10 vs. 13 days; P < 0.001) in comparison with the stoma group. There were no differences between the two groups with regard to repeat hospital admissions within 90 days and 1 year. However, there were more repeat interventions after 1 year in the stent group than in the stoma group (23 [13.4%] vs. < 11 [< 6.4%]; P = 0.004). Most of the patients who had to undergo a repeat procedure within 1 year after stent placement received a new stent (> 70%). The rate of perforations was so low (fewer than 10 events) that according to the authors no conclusions can be drawn about it.

Interestingly, more patients underwent stent therapy in 2012 and 2013 than in 2009–2011 (101 [58.7%] vs. 71 [41.3%], P = 0.003), most likely corresponding to the technical advances being made with SEMS stents.

Demographic and geographical criteria also appear to have an influence on the individual outcome after stent or stoma placement, according to the study’s results. Most patients who received stents were treated in large hospitals (104 [60.5%]) in comparison with medium-sized (42 [24.4%]) and small institutions (26 [15.1%], P < 0.001). The patients in the stent group lived significantly closer to large (endoscopy) centers in comparison with those in the stoma group (median [interquartile range], 4.5 [3.4–15.1] vs. 9.5 [4.5–25.7] km, P < 0.001).

These data were confirmed in a subsequent “adjusted and matched” analysis. Patients who received stents had significantly shorter hospital stays (odds ratio [OR], 0.50; 95% CI, 0.26 to 0.97; P = 0.04), significantly fewer deaths in hospital (OR, 0.40; 95% CI, 0.14 to 1.10; P = 0.08), fewer transfusions (OR, 0.57; 95% CI, 0.31 to 1.06; P = 0.07) and a lesser need for parenteral nutrition (OR, 0.44; 95% CI, 0.19 to 1.00; P = 0.05) in comparison with the stoma group. This was also reflected in the resulting treatment costs (OR, 0.56; 95% CI, 0.29 to 1.11; P = 0.09). With regard to repeat hospital admissions after 90 days and 1 year, there were again no differences between the two groups. Patients with stents more often required repeat procedures within 1 year (OR, 2.93; 95% CI, 1.12 to 7.68; P = 0.03), but in over 70% of the cases these involved new stent placement or correction of the stent position.

Despite these promising data with regard to the long-term outcome after stent treatment in patients with MLBO, the study has several limitations. A total of 3032 patients were screened or identified in the database in 2009–2013 in the study. However, only just over 10% of these patients were included in the final analysis (a total of 354 patients). A certain amount of selection bias is thus not improbable here. In addition, the study does not provide any details at all about the size of the tumors and their aboral distance, which the reader must find rather surprising in a database analysis. The study’s findings are in any case not applicable to the overall situation in Germany, since around 60% of the patients in the study (in the stent group!) were treated in high-volume centers, implying that the results were strongly weighted toward more experienced endoscopists.

In conclusion, it can be stated that in patients with MLBO due to colorectal carcinoma who are not eligible for curative resection, placing an SEMS in the colon represents a safe and effective treatment option. In experienced centers — where most stent placements for MLBO take place, after all — the perforation rates are low and the long-term results are more than satisfactory. The authors also point out that patients need to be informed and advised about the increased risk of a repeat intervention being needed.

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