Newly developed self-expandable Niti-S MD colonic metal stent for malignant colonic obstruction

doi:10.4240/wjgs.v12.i4.138

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World Journal of Gastrointestinal Surgery

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1948-9366

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Retrospective Cohort Study

World J Gastrointest Surg. Apr 27, 2020; 12(4): 138-148
Published online Apr 27, 2020. doi: 10.4240/wjgs.v12.i4.138

Table 1 Patients’ demographics and clinical characteristics in each group

	Group W (n = 37)	Group N (n = 53)	Group MD (n = 20)	Total (n = 110)
Patients’ characteristics
Age (yr, mean ± SD)	71.4 ± 11.8	74.3 ± 13.6	73.7 ± 9.6	73.5 ± 12.5
Male/Female	18/19	28/25	15/5	61/49
PS score (mean ± SD)	1.6 ± 1.2	1.9 ± 1.2	2.3 ± 1.0	1.9 ± 1.2
Therapeutic intent
BTS	19/37 (51.4%)	32/53 (60.4%)	10/20 (50%)	61/110 (55.5%)
PAL	18/37 (48.6%)	21/53 (39.6%)	10/20 (50%)	49/110 (44.5%)
Tumor characteristics
Obstruction/tumor site
Right colon	8/37 (21.6%)	14/53 (26.4%)	6/20 (30%)	28/110 (25.4%)
Left colon	27/37 (73.0%)	38/53 (71.7%)	10/20 (50%)	75/110 (68.2%)
Rectum	2/37 (5.4%)	1/53 (1.9%)	4/20 (20%)	7/110 (6.4%)
Etiology of colorectal obstruction
Primary colorectal cancer	30/37 (81.1%)	49/53 (92.5%)	13/20 (65%)	92/110 (83.6%)
Metastatic lesion	7/37 (18.9%)	4/53 (7.5%)	7/20 (35%)	18/110 (16.4%)
Noncancerous stenosis	0/37 (0%)	0/53 (0%)	0/20 (0%)	0/110 (0%)
Stenosis length [cm, median (range)]	5.0 (2.0-13.0)	5.0 (2.0-11.0)	6.2 (2.5-11.5)	5.0 (2.0-13.0)

BTS: Bridge-to-surgery; PAL: Palliative.

Table 2 Outcomes in each stent group, Group W, Group N, and Group MD

	Group W	Group N	Group MD	Total
Technical success rate	37/37 (100%)	53/53 (100%)	20/20 (100%)	110/110 (100%)
Stent length
6 cm	24/37 (64.9%)	12/53 (22.6%)	3/20 (15%)	39/110 (35.5%)
8 cm	NA	17/53 (32.1%)	7/20 (35%)	24/110 (21.8%)
9 cm	11/37 (29.7%)	NA	NA	11/110 (10.0%)
10 cm	NA	18/53 (34.0%)	6/20 (30%)	24/110 (21.8%)
12 cm	2/37 (5.4%)	6/53 (11.3%)	4/20 (20%)	12/110 (10.9%)
Stent diameter
18 mm	NA	6/53 (11.3%)	NA	6/110 (5.5%)
22 mm	30/37 (81.1%)	47/53 (88.7%)	20/20 (100%)	97/110 (88.2%)
25 mm	7/37 (18.9%)	NA	NA	7/110 (6.3%)
Procedure time (min, mean ± SD)	32.6 ± 14.0	33.6 ± 23.7	31.3 ± 11.2	33.0 ± 19.1
Clinical success rate	33/37 (89.2%)	51/53 (96.2%)	20/20 (100%)	104/110 (94.5%)
BTS	19/19 (100%)	31/32 (96.9%)	10/10 (100%)	60/61 (98.4%)
PAL	14/18 (77.8%)	20/21 (95.2%)	10/10 (100%)	44/49 (89.8%)
CROSS before stent placement (mean ± SD)	1.6 ± 1.3	1.2 ± 1.0	1.4 ± 0.9	1.4 ± 1.1
0	12/37 (32.5%)	10/53 (18.9%)	3/20 (15%)	25/110 (22.7%)
1	8/37 (21.6%)	32/53 (60.4%)	9/20 (45%)	49/110(44.6%)
2	3/37 (8.1%)	4/53 (7.5%)	5/20 (25%)	12/110 (10.9%)
3	13/37 (35.1%)	5/53 (9.4 %)	3/20 (15%)	21/110 (19.1%)
4	1/37 (2.7%)	2/53 (3.8%)	0/20 (0%)	3/110 (2.7%)
CROSS after stent placement (mean ± SD)	3.8 ± 0.8^a	3.8 ± 0.7^a	3.8 ± 0.5^a	3.8 ± 0.7^a
0	0/37 (0%)	0/53 (0%)	0/20 (0%)	0/110 (0%)
1	3/37 (8.1%)	2/53 (3.8%)	0/20 (0%)	5/110(4.6%)
2	0/37 (0%)	2/53 (3.8%)	1/20 (5.0%)	3/110 (2.7%)
3	0/37 (0%)	0/53 (0 %)	2/20 (10%)	2/110 (1.8%)
4	34/37 (91.9%)	49/53 (92.4%)	17/20 (85%)	110/110 (90.9%)

The CROSS score after stent placement was significantly higher than one before treatment,

^aP < 0.01. BTS: Bridge-to-surgery; PAL: Palliative; CROSS: ColoRectal Obstruction Scoring System; NA: Not available.

Table 3 Early and late adverse events

	Group W	Group N	Group MD	Total
Early (≤ 7 d)
Perforations	0/37 (0%)	2/53 (3.8%)¹	0/20 (0%)	2/110 (1.8%)
Bleeding	0/37 (0%)	0/53 (0%)	0/20 (0%)	0/110 (0%)
Poor expansion	1/37 (2.7%)	0/53 (0%)	0/20 (0%)	1/110 (0.9%)
Abdominal pain	3/37 (8.1%)	0/53 (0%)	0/20 (0%)	3/110 (2.7%)
Stent occlusion	0/37 (0%)	0/53 (0%)	0/20 (0%)	0/110 (0%)
Fever	1/37 (2.7%)	0/53 (0%)	0/20 (0%)	1/110 (0.9%)
Late (> 7 d)
Perforations	4/36 (11.1%)^a²	0/51 (0%)^a	0/20 (0%)	4/107 (3.7%)
Bleeding	0/36 (0%)	0/51 (0%)	0/20 (0%)	0/107 (0%)
Stent migration	0/36 (0%)	0/51 (0%)	0/20 (0%)	0/107 (0%)
Abdominal pain	0/36 (0%)	0/51 (0%)	0/20 (0%)	0/107 (0%)
Stent occlusion	1/36 (2.8%)	2/51 (3.9%)	0/20 (0%)	3/107 (2.8%)

¹Perforation occurred due to obstructive colitis in all two cases;

²All four cases were stent-related perforation.

^aP < 0.05.

Citation: Miyasako Y, Kuwai T, Ishaq S, Tao K, Konishi H, Miura R, Sumida Y, Kuroki K, Tamaru Y, Kusunoki R, Yamaguchi A, Kouno H, Kohno H. Newly developed self-expandable Niti-S MD colonic metal stent for malignant colonic obstruction. World J Gastrointest Surg 2020; 12(4): 138-148
URL: https://www.wjgnet.com/1948-9366/full/v12/i4/138.htm
DOI: https://dx.doi.org/10.4240/wjgs.v12.i4.138