Browsing by Author "Irani, Shayan S."

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    EUS-directed transgastric interventions in Roux-En-Y Gastric Bypass anatomy: a multicenter experience
    (Elsevier, 2022-05) Ghandour, Bachir; Shinn, Brianna; Dawod, Qais M.; Fansa, Sima; El Chafic, Abdul Hamid; Irani, Shayan S.; Pawa, Rishi; Gutta, Aditya; Ichkhanian, Yervant; Paranandi, Bharat; Pawa, Swati; Al-Haddad, Mohammad A.; Zuchelli, Tobias; Huggett, Matthew T.; Bejjani, Michael; Sharaiha, Reem Z.; Kowalski, Thomas E.; Khashab, Mouen A.; Medicine, School of Medicine
    Background and Aims Placement of a Lumen Apposing Metal Stent (LAMS) between the gastric pouch and the excluded stomach allows for EUS Guided Transgastric Interventions (EDGI) in patients with Roux-en-Y gastric bypass (RYGB). Although EUS guided transgastric ERCP (EDGE) outcomes have been reported, there is a paucity of data on other endoscopic interventions. We aimed to evaluate the outcomes and safety of EDGI. Methods This is a retrospective study involving 9 centers (8 USA, 1 Europe) and included patients with RYGB who underwent EDGI between 06/2015 and 09/2021. The primary outcome was the technical success of EDGI. Secondary outcomes included adverse events, length of hospital stay, and fistula follow-up and management. Results 54 EDGI procedures were performed in 47 patients (mean age 61yr, F 72%), most commonly for the evaluation of a pancreatic mass (n=16) and management of pancreatic fluid collections (n=10). A 20mm LAMS was utilized in 26 patients and a 15mm LAMS in 21, creating a gastrogastrostomy (GG) in 37 patients and jejunogastrostomy (JG) in 10. Most patients (n=30, 64%) underwent a dual-session EDGI, with a median interval of 17d between the 2 procedures. Single-session EDGI was performed in 17 patients, of whom 10 (59%) had anchoring of the LAMS. The most common interventions were diagnostic EUS (+/-FNA/B) (n=28) and EUS-guided cystgastrostomy (n=8). The mean procedural time was 97.6 ± 78.9 mins. Technical success was achieved in 52 (96%). AEs occurred in 5 (10.6%) patients, of which only 1 (2.1%) was graded as severe. Intraprocedural LAMS migration was the most common AE, occurring in 3 patients (6.4%), while delayed spontaneous LAMS migration occurred in 2 (4.3%). 4 of the 5 LAMS migration events were managed endoscopically, and one required surgical repair. LAMS anchoring was found to be protective against LAMS migration (p=0.001). The median duration of hospital stay was 2.1 ± 3.7d. Of the 17 patients who underwent objective fistula assessment endoscopically/radiologically after LAMS removal, 2 (11.7%) were found to have persistent fistulas. In one case the fistula was intentionally left open to assist with weight gain. The other fistula was successfully closed endoscopically. Conclusion EDGI is effective and safe for the diagnosis and management of pancreatobiliary and foregut disorders in RYGB patients. It is associated with high rates of technical success and low rates of severe AEs. LAMS migration is the most common AE with evidence that anchoring can be protective against its occurrence. Persistent fistulas may occur, but endoscopic closure seems effective.
  • Thumbnail Image
    Item
    Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial
    (Elsevier, 2023) Sherman, Stuart; Kozarek, Richard A.; Costamagna, Guido; Reddy, Nageshwar; Tarnasky, Paul; Shah, Raj J.; Slivka, Adam; Fogel, Evan; Watkins, James; Delhaye, Myriam; Irani, Shayan S.; Tringali, Andrea; Lakhtakia, Sundeep; Kedia, Prashant; Edmundowicz, Steven; Peetermans, Joyce A.; Rousseau, Matthew J.; Devière, Jacques; Pancreatic SEMS in Chronic Pancreatitis Study Group; Medicine, School of Medicine
    Background and aims: Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain. Methods: Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent. Results: Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65). Conclusions: Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection.