1. First Moscow state medical University n. a. I. M. Sechenov (Moscow, Russian Federation)

Keywords:clinical trials,investigational new drugs,clinical examples,legal and regulatory documentation,international harmonization of clinical trials

Abstract:Phase I/III full clinical trials of investigational new drugs (INDs) and generic bioequivalence studies are conducted using experimental drugs or clinical examples. Clinical examples are most often produced either on pilot plant or on specialized semiwork-scale plants that do not directly involve development of technology. In some cases, full (serial) production might be used for this purpose. Its advantage is non-commercial clinical examples production during the stage of clinical trials and then commercial release (after a medicine registration). Special attention is paid to quality assurance of Clinical examples as it plays an important role in guarantee of trial subjects protection and scientific validity of results. Clinical examples production, in turn, is connected with certain difficulties in comparison with serial production release. This is the result of inadequate optimization of technological processes and control procedures used in the case of the compendial requirements absence toward active substances and dosage forms. Difficulties also arise with production packaging and marking. Moreover, potential negative influence on the personnel involved in manufacture requires better understanding. Consequently, clinical examplesс production should be performed in strict observance of the high-performance quality system principles. This article contains a review and comparison of quality and production requirements for drugs in clinical trials; the high importance of international harmonization in proceedings of full clinical trials with investigational new/innovative molecules is also highlighted. The information is based on Russian and foreign regulatory documentation.

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Full text is published :
Meshkovsky A.P., Pyatigorskaya N.V., Smolyarchuk E.A., Drozdov V.N. et al. DOMESTIC PRACTICE AND INTERNATIONAL EXPERIENCE IN CONDUCTING QUALITY CLINICAL RESEARCH. Experimental and Clinical Gastroenterology Journal. 2017;147(11):64-70
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1. A. V. Vishnevsky Institute of Surgery (Moscow, Russian Federation)

Keywords:ERCP,endoscopic treatment,iatrogenic strictures,posttraumatic strictures,strictures of bile ducts,stenting,plastic stents,metal stents,complications

Abstract:Background. Intraoperative bile duct injury is a serious and potentially life-threatening complication in post-operative period. The treatment of surgical trauma is complex and multiple. The incidence of disability is up to 50 % and duration of treatment is up to 42 weeks. Objective. To estimate the feasibilities of endoscopic treatment of iatrogenic biliary strictures. Material and methods. The series of 19 patients underwent endoscopic treatment of iatrogenic biliary strictures in a period from 2014 to 2017. Treatment protocol included: ERCP, balloon and bougie dilation of strictures followed by stenting with several plastic stents or stenting with one full cover metallic stent. After primary endoscopic procedure all patients underwent step-wise restenting procedures with increasing number of plastic stents. Results. The technical success rate of endoscopic procedures is 100 %. The step-wise endoscopic stenting was completed in 12 out of 16 followed-up patients. The clinical success rate which imlicates full release of the stricture was in 12 out of 12 patients with complete endoscopic treatment. The intraoperative complication included bleeding in one patient, which required stenting with SEMS for hemostasis. The late postoperative complication included new stricture at the upper level was observed in two patients. The recurrent choledoholithiasis was observed in one patients. Conclusion. Endoscopic procedures are effective and safe treatment option for iatrigenic biliary strictures, but more prolonged studies are needed for appropriate assessment of the long-term results.

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Full text is published :
Starkov Y.G., Solodinina E.N., Zamolodchikov R.D., Dzhantukhanova S.V. et al. RESULTS OF ENDOSCOPIC TREATMENT OF POSTTRAUMATIC BILIARY STRICTURES. Experimental and Clinical Gastroenterology Journal. 2017;147(11):71-77
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1. Novosibirsk State Medical University (Novosibirsk, Russian Federation)

Keywords:diverticular disease,Hinchey classification,laparoscopic lavage

Abstract:In the clinic of General surgery Department of Novosibirsk State Medical University from 2005 to 2014 were observed in 43 patients with diverticular disease of the colon. Complications of diverticular disease with acute diverticulitis, paradigmatically infiltrates, abscesses, perforations, peritonitis - 31 patients aged 24 to 84 years. Diverticular disease complicated by bleeding, 12 cases (all women), ranging in age from 63 to 77 years. Acute diverticulitis was found in 11 patients, paradiverticular infiltrates, abscesses, perforation, peritonitis in 20. Conservative treatment in 11 patients was effective. It included infusion therapy, use of broad-spectrum antibiotics, antispasmodics, enteral nutrition mixtures. 20 patients were operated urgent. n 4 cases the draining operations are performed from laparotomy, because laparoscopy was not possible because of the early migrated in open surgery. The average age of the patients in this group was 64.5 + 8,54 years. Acute diverticulitis they have developed for the first time and was consistent with Hinchey III. 8 patients underwent resection of the obstructive, the average age was of 56.10 + 5.43 years. Recurrent diverticulitis have a high complication rate. In Hinchey II-III laparoscopic lavage and drainage are the alternative to Hartmann’s operation.

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Full text is published :
Shtofin S.G., Chekanov M.N., Lyovkin O.Yu., Chekanov A.M. et al. THE COMPLICATED DIVERTICULAR DISEASE - TACTICS . Experimental and Clinical Gastroenterology Journal. 2017;147(11):78-81
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1. Chuvach State University (Cheboksary, Russian Federation)
2. Ogarev Mordovia State University (Saransk, Russian Federation)

Keywords:intestinal anastomosis failure,nasogastric,retrograde intestinal intubation,enteral nutrition

Abstract:Purpose of the study. Improving of results of treatment of the intestinal anastomosis failure. Material and methods. The method of treatment failure intestinal anastomosis is to move the jejunal loops with anastomotic leak on the anterior abdominal wall with the combination of nasointestinal and retrograde intubation of the jejunum through the ileostomy. It was used in 5 patients of the main group. In 11 patients with the comparison group it was used without retrograde intubation of the jejunum. Results. In the group with using of the nasogastric intubation and retrograde intestinal all 5 operated patients recovered. Conclusion. The main advantages of combined intestinal intubation are the earlier recovery of intestinal paresis and following self-healing of intestinal fistula.

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Full text is published :
Prokhorov G.P., Belyaev A.N., Chekanov M.N., Mizurov N.A. et al. THE METHOD OF INTUBATION INTESTINAL IN PATIENTS WITH ANASTOMOSIS FAILURE . Experimental and Clinical Gastroenterology Journal. 2017;147(11):82-85
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