Advertisement

A phase II trial of lanreotide for the prevention of postoperative pancreatic fistula

      Abstract

      Background

      Clinically relevant postoperative pancreatic fistula (CR-POPF) is a significant contributor to morbidity after pancreatectomy. Somatostatin analogues have shown variable efficacy in the prevention of CR-POPF. Lanreotide is a somatostatin analogue ideally suited for perioperative use due to its long half-life and favorable side effect profile.

      Methods

      We conducted a phase II single-arm trial of a single dose of preoperative lanreotide (120 mg) in patients undergoing either pancreaticoduodenectomy (PD) or distal pancreatectomy (DP). The primary outcome was development of CR-POPF or intra-abdominal abscess. Secondary outcomes included biochemical leak and overall morbidity.

      Results

      A total of 98 patients completed the study. Sixty-two underwent PD (63.3%) and 36 underwent DP (36.7%). The primary outcome was observed in eight (8%) patients in the overall cohort, one from the DP group and seven from the PD group. Biochemical leak was detected in 12 (12.2%) patients in the overall cohort. Twenty-seven (27.5%) patients developed complications, of which 14 (14.2%) were major complications. Drug-related adverse events were limited to mild skin reactions in two (2%) patients.

      Conclusion

      Patients who received preoperative lanreotide developed CR-POPF at rates significantly lower than historical controls or published literature. This provides strong justification for a randomized controlled trial.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to HPB
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Swanson R.S.
        • Pezzi C.M.
        • Mallin K.
        • Loomis A.M.
        • Winchester D.P.
        The 90-day mortality after pancreatectomy for cancer is double the 30-day mortality: more than 20,000 resections from the national cancer data base.
        Ann Surg Oncol. 2014; 21: 4059-4067https://doi.org/10.1245/s10434-014-4036-4
        • van der Gaag N.A.
        • Rauws E.A.
        • van Eijck C.H.
        • Bruno M.J.
        • van der Harst E.
        • Kubben F.J.
        • et al.
        Preoperative biliary drainage for cancer of the head of the pancreas.
        N Engl J Med. 2010; 362: 129-137
        • Reid-Lombardo K.M.
        • Farnell M.B.
        • Crippa S.
        • Barnett M.
        • Maupin G.
        • Bassi C.
        • et al.
        Pancreatic anastomotic leakage after pancreaticoduodenectomy in 1,507 patients: a report from the pancreatic anastomotic leak study group.
        J Gastrointest Surg. 2007; 11: 1451-1458https://doi.org/10.1007/s11605-007-0270-4
        • Bassi C.
        • Marchegiani G.
        • Dervenis C.
        • Sarr M.
        • Abu Hilal M.
        • Adham M.
        • et al.
        The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years after.
        Surgery. 2017; 161: 584-591https://doi.org/10.1016/j.surg.2016.11.014
        • Hashimoto Y.
        • Traverso L.W.
        Pancreatic anastomotic failure rate after pancreaticoduodenectomy decreases with microsurgery.
        J Am Coll Surg. 2010; 211: 510-521https://doi.org/10.1016/j.jamcollsurg.2010.06.018
        • Shukla P.J.
        • Barreto S.G.
        • Fingerhut A.
        • Bassi C.
        • Buchler M.W.
        • Dervenis C.
        • et al.
        Toward improving uniformity and standardization in the reporting of pancreatic anastomoses: a new classification system by the International Study Group of Pancreatic Surgery (ISGPS).
        Surgery. 2010; 147: 144-153https://doi.org/10.1016/j.surg.2009.09.003
        • Gurusamy K.S.
        • Koti R.
        • Fusai G.
        • Davidson B.R.
        Somatostatin analogues for pancreatic surgery.
        Cochrane Database Syst Rev. 2013; https://doi.org/10.1002/14651858.CD008370
        • Allen P.J.
        Pasireotide for postoperative pancreatic fistula.
        N Engl J Med. 2014; 371: 875-876
        • Caron P.
        Lanreotide Autogel® in acromegaly and neuroendocrine tumors.
        Clin Pract. 2007; 4: 9https://doi.org/10.2217/14750708.4.1.9
        • Wolin E.M.
        • Manon A.
        • Chassaing C.
        • Lewis A.
        • Bertocchi L.
        • Richard J.
        • et al.
        Lanreotide depot: an antineoplastic treatment of carcinoid or neuroendocrine tumors.
        J Gastrointest Cancer. 2016; 47: 366-374https://doi.org/10.1007/s12029-016-9866-9
        • Caplin M.E.
        • Pavel M.
        • Cwikla J.B.
        • Phan A.T.
        • Raderer M.
        • Sedlackova E.
        • et al.
        Lanreotide in metastatic enteropancreatic neuroendocrine tumors.
        N Engl J Med. 2014; 371: 224-233
        • Callery M.P.
        • Pratt W.B.
        • Kent T.S.
        • Chaikof E.L.
        • Vollmer Jr, C.M.
        A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy.
        J Am Coll Surg. 2013; 216: 1-14https://doi.org/10.1016/j.jamcollsurg.2012.09.002
        • Bonaroti J.W.
        • Zenati M.S.
        • Al-Abbas A.I.
        • Rieser C.J.
        • Zureikat A.H.
        • Hogg M.E.
        • et al.
        Impact of postoperative pancreatic fistula on long-term oncologic outcomes after pancreatic resection.
        HPB. 2021; 23: 1269-1276https://doi.org/10.1016/j.hpb.2020.12.010
        • Enestvedt C.K.
        • Diggs B.S.
        • Cassera M.A.
        • Hammill C.
        • Hansen P.D.
        • Wolf R.F.
        Complications nearly double the cost of care after pancreaticoduodenectomy.
        Am J Surg. 2012; 204: 332-338https://doi.org/10.1016/j.amjsurg.2011.10.019
        • Daniel S.K.
        • Thornblade L.W.
        • Mann G.N.
        • Park J.O.
        • Pillarisetty V.G.
        Standardization of perioperative care facilitates safe discharge by postoperative day five after pancreaticoduodenectomy.
        PLoS One. 2018; : 13https://doi.org/10.1371/journal.pone.0209608
        • Cameron J.L.
        • He J.
        Two thousand consecutive pancreaticoduodenectomies.
        J Am Coll Surg. 2015; 220: 530-536https://doi.org/10.1016/j.jamcollsurg.2014.12.031