NCT05638789 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R
Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.
Attam R, Freeman ML
Endoscopic papillary large balloon dilation for large common bile duct stones. J Hepatobiliary Pancreat Surg. 2009;16(5):618-23. doi: 10.1007/s00534-009-0134-2. Epub 2009 Jun 24.
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N
Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
Fu BQ, Xu YP, Tao LS, Yao J, Zhou CS
Endoscopic papillary balloon intermittent dilatation and endoscopic sphincterotomy for bile duct stones. World J Gastroenterol. 2013 Apr 21;19(15):2425-32. doi: 10.3748/wjg.v19.i15.2425.
Shim CS, Kim JW, Lee TY, Cheon YK
Is endoscopic papillary large balloon dilation safe for treating large CBD stones? Saudi J Gastroenterol. 2016 Jul-Aug;22(4):251-9. doi: 10.4103/1319-3767.187599.
Staritz M, Ewe K, Goerg K, Meyer zum Buschenfelde KH
Endoscopic balloon tamponade for conservative management of severe hemorrhage following endoscopic sphincterotomy. Z Gastroenterol. 1984 Nov;22(11):644-6.
Suissa A, Yassin K, Lavy A, Lachter J, Chermech I, Karban A, Tamir A, Eliakim R
Outcome and early complications of ERCP: a prospective single center study. Hepatogastroenterology. 2005 Mar-Apr;52(62):352-5.

Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duct Stones Removal

Details for clinical trial NCT05638789

Clinical trial NCT05638789 - References