Devereaux Benedict M, Fein Seymour, Purich Edward, Trout J Richard, Lehman Glen A, Fogel Evan L, Phillips Susan, Etemad Robert, Jowell Paul, Toskes Phillip P, Sherman Stuart
Division of Gastroenterology/Hepatology, Indiana University Medical Center, Indianapolis 46202, USA.
Gastrointest Endosc. 2003 May;57(6):643-7. doi: 10.1067/mge.2003.195.
Secretin, a 27 amino acid polypeptide released in response to duodenal luminal acidification, stimulates secretion of water and bicarbonate from pancreatic ductal cells. To date the only secretin available for clinical use has been a biologically derived compound extracted from porcine duodenums. Although used to facilitate pancreatic duct cannulation, secretin has not been approved for this indication. In this study, a new synthetic porcine secretin with an identical amino acid composition was compared with saline solution for the facilitation of minor papilla cannulation in patients with pancreas divisum.
A multicenter, prospective, randomized, placebo-controlled, double-blind, comparative trial was conducted at 4 centers with expertise in pancreaticobiliary endoscopy. Patients with pancreas divisum in whom minor papilla cannulation initially was unsuccessful were enrolled. Either saline solution (placebo) or synthetic porcine secretin was administered. If the minor papilla orifice and/or pancreatic juice flow was noted, cannulation was attempted and success or failure was documented (phase 1), as well as the time taken for successful cannulation. If cannulation was unsuccessful, no juice flow was noted, or the orifice was not seen, the alternate agent was administered (phase 2).
Twenty-nine patients (7 men, 22 women; mean age 51 years, range 21-76 years) were enrolled. In phase 1, cannulation was achieved in 1 of 13 patients (7.7%) after the placebo was given and in 13 of 16 patients (81.3%) after synthetic porcine secretin was given (p < 0.0001). In phase 2, cannulation was achieved in 12 of 12 patients (100%) after synthetic porcine secretin was given and in 0 of 3 patients (0%) after the placebo was given (p = 0.0022). Overall, cannulation was successful in 25 of 28 patients (89.3%) who received synthetic porcine secretin and in 1 of 16 (6.3%) who received the placebo (p < 0.0001). Mean time to cannulation was significantly greater for the placebo than for the synthetic porcine secretin (4.75 min vs. 2.63 min; p = 0.0001). No adverse events directly attributable to synthetic porcine secretin administration were documented.
This study confirmed the use and safety of synthetic porcine secretin in facilitating cannulation of the minor papilla in patients with pancreas divisum in whom cannulation was difficult. Use of this agent has the potential to further increase the cannulation success rate in this group of patients.
促胰液素是一种由27个氨基酸组成的多肽，在十二指肠腔酸化时释放，可刺激胰腺导管细胞分泌水和碳酸氢盐。迄今为止，临床上可用的唯一促胰液素是从猪十二指肠中提取的生物衍生化合物。尽管促胰液素用于辅助胰管插管，但尚未被批准用于此适应症。在本研究中，将一种具有相同氨基酸组成的新型合成猪促胰液素与生理盐水进行比较，以辅助胰腺分裂症患者的小乳头插管。
在4个具有胰胆内镜专业知识的中心进行了一项多中心、前瞻性、随机、安慰剂对照、双盲、比较试验。纳入最初小乳头插管未成功的胰腺分裂症患者。给予生理盐水（安慰剂）或合成猪促胰液素。如果观察到小乳头开口和/或胰液流出，则尝试插管，并记录成功或失败情况（第1阶段），以及成功插管所需的时间。如果插管未成功，未观察到胰液流出或未看到开口，则给予另一种药物（第2阶段）。
共纳入29例患者（7例男性，22例女性；平均年龄51岁，范围21 - 76岁）。在第1阶段，给予安慰剂后，13例患者中有1例（7.7%）成功插管；给予合成猪促胰液素后，16例患者中有13例（81.3%）成功插管（p < 0.0001）。在第2阶段，给予合成猪促胰液素后，12例患者中有12例（100%）成功插管；给予安慰剂后，3例患者中有0例（0%）成功插管（p = 0.0022）。总体而言，接受合成猪促胰液素的28例患者中有25例（89.3%）插管成功，接受安慰剂的16例患者中有1例（6.3%）插管成功（p < 0.0001）。安慰剂组的平均插管时间显著长于合成猪促胰液素组（4.75分钟对2.63分钟；p = 0.0001）。未记录到直接归因于合成猪促胰液素给药的不良事件。
本研究证实了合成猪促胰液素在辅助胰腺分裂症患者小乳头插管困难时的使用及安全性。使用该药物有可能进一步提高该组患者的插管成功率。
