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Short-term outcome of Colonic Stent ( WallFlex ) prospective feasibility study. Tomonori Yamada 1,2 1.Gastroenterology, Japanese Red Cross Nagoya Daini Hospital 2. Colonic Stent Safe Procedure Research Group. Conflicts of Interest. The author have no financial conflicts of interest.

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short term outcome of colonic stent wallflex prospective feasibility study

Short-term outcome of Colonic Stent (WallFlex) prospective feasibility study

Tomonori Yamada1,2

1.Gastroenterology, Japanese Red Cross Nagoya Daini Hospital

2. Colonic Stent Safe Procedure Research Group

conflicts of interest
Conflicts of Interest
  • The author have no financial conflicts of interest.
background and aims
Background and Aims
  • The self-expandable metal stent (SEMS) can alleviate malignant colonic obstruction and avoid emergency decompression surgery.
  • The colorectal SEMS was not approved by the Japanese Ministry of Health, Labour and Welfare until 2011.
  • The aim of our study was to evaluate the efficacy and safety of SEMS in patients with malignant colorectal obstruction.
short term outcome within 7 days
Short term outcome within 7 days

BTS

Surgery

Malignant

colorectal

obstruction

Stent

Palliative

  • Study design: Prospective, Observational study
  • Technical success rate
  • Clinical success rate
  • Safety profiles: short term
inclusion exclusion criteria
Inclusion/ Exclusion criteria
  • Patients requiring palliative and bridge to surgery treatment of colorectal obstruction by malignant neoplasms.
  • Only patients with no previous colonic stenting will be included in the registry.
  • Previous colonic stent placement
  • Enteral ischemia
  • Suspected or impending perforation
  • Intra-abdominal abscess/perforation
  • Contra-indication for endoscopic procedure
  • Benign stricture
  • Any use of the stent except outlined indication for use
device and procedure
Device and Procedure
  • WallFlex Enteral Colonic Stent(Boston Scientific)
    • Uncovered type
    • Diameter 22 and 25mm
    • Length 6, 9, and 12cm
  • Under endoscopic and fluoroscopic guidance
patient cohorts
Patient cohorts

N=517: Procedural Success Analysis

Enrolled Patients (ITT)

3 not enough stenosis

1 no evidence of stenosis

1 benign stricture

5 excluded

N=512: Per-protocol Analysis Cohort

baseline characteristics 1
Baseline characteristics 1

N=512

Age, median(range), years

72 (25-101)

289/ 223

Sex, male/female, n

Symptoms of obstruction

Constipation, %

90.0

Abdominal pain/ cramps, %

72.5

Bloating, %

79.7

Nausea/ Vomiting, %

47.1

Performance Status

0/ 1/ 2/ 3/ 4, n

221/ 136/ 64/ 66/ 25

CROSS

0/ 1/ 2/ 3/ 4, n

183/ 150/ 72/ 77/ 30

technical success data
Technical success data

% (n/512)

Yes

97.9 (501)

No

2.1 (11)

Impossible to pass guidewire

1.4 (7)

Perforation by guidewire

0.4 (2)

Perforation by ERCP catheter

0.2 (1)

Not accessible by endoscope

0.2 (1)

clinical success data
Clinical success data
  • Clinical success defined as a resolution of symptoms and radiological relief of the obstruction within 24 h.

% (n/512)

Yes

96.1 (492)

3.9 (20)

No

No technical success

2.1 (11)

Poor expansion

0.6 (3)

Perforation

0.6 (3)

Inadequate decompression

0.2 (1)

Multiple obstruction

0.4 (2)

safety profile within 7days
Safety profile within 7days

% (n/492)

Migration

1.6 (8)

Re-obstruction

1.2 (6)

Perforation

0.6 (3)

Multiple-obstruction

0.4 (2)

Tenesmus

0.2 (1)

Appendicitis

0.2 (1)

summary
Summary
  • Technical success rate was 97.9%.
  • Clinical success rate within 24h
  • was 96.1%.
  • Perforation rate was 1.8% (9/512).
conclusion
Conclusion

In our multicenter prospective study,

the WallFlex Colonic Stent provided a safe and highly successful short-term treatment of malignant colorectal obstruction.