title: Feasibility and safety of placement of a newly designed, fully covered self-expandable metal stent for refractory benign pancreatic ductal strictures: a pilot study (with video).
abstract: BACKGROUND
  Painful chronic pancreatitis with main pancreatic ductal strictures is usually managed with endotherapy with a plastic stent. To date, the role of placement of metallic stents, especially uncovered ones in benign pancreatic ductal stricture, has been unsatisfactory as a result of stent dysfunction related to mucosal hyperplasia.
  
  
  OBJECTIVE
  We explored the feasibility and safety of temporary placement of a newly designed, fully covered self-expandable metal stent (FCSEMS) in painful chronic pancreatitis and refractory benign pancreatic ductal strictures.
  
  
  METHODS
  A prospective pilot and feasibility study.
  
  
  METHODS
  A tertiary academic center.
  
  
  METHODS
  Thirteen patients with chronic painful pancreatitis of alcoholic (8) or idiopathic (5) etiology.
  
  
  METHODS
  ERCP with temporary FCSEMS placement (2 months). Endoscopic removal of FCSEMSs was performed with a snare or rat-tooth forceps.
  
  
  METHODS
  End points were feasibility, safety, and morbidity.
  
  
  RESULTS
  Successful FCSEMS placement was performed in all enrolled patients. After immediate placement of FCSEMS, 2 patients had mild acute pancreatitis related mainly to the stricture dilation procedure (Soehendra stent retriever or balloon dilation). Complications associated with stent placement included 5 migrations (39%, 1 proximal and 4 distal) and 2 incidents of cholestatic liver dysfunction associated with the compression of the bile duct orifice by expansion of FCSEMSs. In 1 patient with proximal migration, the stent was repositioned by an inflated retrieval balloon. Additional endoscopic biliary sphincterotomy with or without biliary stenting was performed in 2 patients with cholestatic liver dysfunction. There was no occurrence of pancreatic sepsis among any patients. FCSEMSs were removed from 9 of 9 patients without stent migration (100% [9/9] as per protocol, and 69% [9/13] as intention to treat, respectively). Improvement or resolution of the pancreatic ductal strictures was confirmed in all 13 patients on follow-up ERCP (2 months after stent placement), regardless of stent migration.
  
  
  CONCLUSIONS
  Small patient populations without long-term follow-up.
  
  
  CONCLUSIONS
  Two-month placement of FCSEMSs in patients with refractory benign pancreatic ductal strictures may be feasible and relatively safe. However, stent migration was not uncommon. A further investigation with ideal stent design may therefore be needed before recommending FCSEMSs as a therapeutic option for refractory benign pancreatic ductal strictures.
authors.affiliation: Department of Internal Medicine, Division of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: Do Hyun
authors.initials: DH
authors.lastname: Park
authors.forename: Myung-Hwan
authors.initials: MH
authors.lastname: Kim
authors.forename: Sung-Hoon
authors.initials: SH
authors.lastname: Moon
authors.forename: Sang Soo
authors.initials: SS
authors.lastname: Lee
authors.forename: Dong-Wan
authors.initials: DW
authors.lastname: Seo
authors.forename: Sung-Koo
authors.initials: SK
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D003251:Constriction, Pathologic; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010183:Pancreatic Ducts / Q000473:pathology* / Q000601:surgery*; D010865:Pilot Projects; D011446:Prospective Studies; D011474:Prosthesis Design; D012449:Safety; D015607:Stents / Q000009:adverse effects