Bonanomi G, Prince JM, McSteen F, Schauer PR, Hamad GG Sealing effect of fibrin glue on the healing of gastrointestinal anastomoses: implications for the endoscopic treatment of leaks. Surg Endosc. 2004 Nov;18(11):1620-4. Epub 2004 Oct 11.
Dutta S, Fullarton GM, Forshaw MJ, Horgan PG, McMillan DC Persistent elevation of C-reactive protein following esophagogastric cancer resection as a predictor of postoperative surgical site infectious complications. World J Surg. 2011 May;35(5):1017-25. doi: 10.1007/s00268-011-1002-1.
Jones CM, Clarke B, Heah R, Griffiths EA Should routine assessment of anastomotic integrity be undertaken using radiological contrast swallow after oesophagectomy with intra-thoracic anastomosis? Best evidence topic (BET). Int J Surg. 2015 Aug;20:158-62. doi: 10.1016/j.ijsu.2015.06.076. Epub 2015 Jul 10. Review.
Kjaergard HK, Fairbrother JE Controlled clinical studies of fibrin sealant in cardiothoracic surgery--a review. Eur J Cardiothorac Surg. 1996;10(9):727-33. Review.
Maher JW, Bakhos W, Nahmias N, Wolfe LG, Meador JG, Baugh N, Kellum JM Drain amylase levels are an adjunct in detection of gastrojejunostomy leaks after Roux-en-Y gastric bypass. J Am Coll Surg. 2009 May;208(5):881-4; discussion 885-6. doi: 10.1016/j.jamcollsurg.2008.12.022. Epub 2009 Mar 26.
Perry Y, Towe CW, Kwong J, Ho VP, Linden PA Serial Drain Amylase Can Accurately Detect Anastomotic Leak After Esophagectomy and May Facilitate Early Discharge. Ann Thorac Surg. 2015 Dec;100(6):2041-6; discussion 2046-7. doi: 10.1016/j.athoracsur.2015.05.092. Epub 2015 Aug 25.
Strauss C, Mal F, Perniceni T, Bouzar N, Lenoir S, Gayet B, Palau R Computed tomography versus water-soluble contrast swallow in the detection of intrathoracic anastomotic leak complicating esophagogastrectomy (Ivor Lewis): a prospective study in 97 patients. Ann Surg. 2010 Apr;251(4):647-51. doi: 10.1097/SLA.0b013e3181c1aeb8.
Yoo HM, Lee HH, Shim JH, Jeon HM, Park CH, Song KY Negative impact of leakage on survival of patients undergoing curative resection for advanced gastric cancer. J Surg Oncol. 2011 Dec;104(7):734-40. doi: 10.1002/jso.22045. Epub 2011 Jul 25.
Yuan Y, Zeng X, Hu Y, Xie T, Zhao Y Omentoplasty for esophagogastrostomy after esophagectomy. Cochrane Database Syst Rev. 2012 Nov 14;11:CD008446. doi: 10.1002/14651858.CD008446.pub2. Review. Update in: Cochrane Database Syst Rev. 2014;10:CD008446.
The Use of Fibrin Glue Sealant (Tisseel®) as a Reinforcement of Esophagojejunal Anastomoses Will Decrease the Rate of Anastomotic Leak.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.