Critical View of Safety in Laparoscopic Cholecystectomy

• ClinicalTrials.gov Identifier: NCT03696823
• Recruitment Status: Unknown
• First Posted: October 5, 2018
• Last Update Posted: October 5, 2018
• Sponsor: Assiut University
• Information provided by (Responsible Party): Abanoub Khalf Henry Romany, Assiut University

Study Description

Brief Summary:

This prospective cohort study aims to assess feasibility and safety of the approach of critical view of safety during laparoscopic cholecystectomy

Condition or disease	Intervention/treatment	Phase
Chronic Calculous Cholecystitis	Procedure: laparoscopic cholecystectomy	Not Applicable

Detailed Description:

Since the introduction and routine use of laparoscopic cholecystectomy in the 1990s, the reported incidence of biliary injuries has doubled to 0.4%.

Many factors have been shown to influence the risk of biliary injury including patient factors (obesity, older age, male gender and adhesions), local factors (severe gallbladder inflammation/infection, aberrant anatomy and haemorrhage) as well as surgeon experience.

Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury Active identification of cystic structures within Calot's triangle is the key to a reduction in biliary injury. Strasberg first coined the term 'critical view of safety' (CVS) in 1958 and this approach of identification of cystic structures has been adopted by many surgeons as the standard of operative technique to reduce the incidence of biliary injury.

To fulfil the criteria for a CVS requires Calot's triangle to be cleared free of fat and fibrous tissue ('fat cleared'), for the lowest part of the gallbladder to be dissected free from the cystic plate ('liver visible') and for there to be only two structures entering the gallbladder ('2 structures').

The published rate of bile duct injury with this approach is very low However more studies are needed to assess risk benefit rate of this approach.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment of Routine Use of Critical View of Safety in Laparoscopic Cholecystectomy, Prospective Cohort Study
• Estimated Study Start Date: October 1, 2018
• Estimated Primary Completion Date: October 2019
• Estimated Study Completion Date: November 2019

Arms and Interventions

Intervention Details:

• Procedure: laparoscopic cholecystectomy
  treatment of chronic calcular cholecystitis laparoscopically

Outcome Measures

Primary Outcome Measures :

1. (CVS) is a mean of target identification, the targets being the cystic duct and artery for changes in the incidence of biliary injury. Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury. [ Time Frame: baseline & 6 months ]

   Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury.

   Active identification of cystic structures within Calot's triangle is the key to a reduction in biliary injury.

   To fulfil the criteria for a CVS requires Calot's triangle to be cleared free of fat and fibrous tissue ('fat cleared'), for the lowest part of the gallbladder to be dissected free from the cystic plate ('liver visible') and for there to be only two structures entering the gallbladder ('2 structures').

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• include all patients who will have laparoscopic cholecystectomy

Exclusion Criteria :-

• Emergency laparoscopic cholecystectomy
• Liver cirrhosis
• HCV & HBV

Contacts and Locations

Contacts

Contact: Abanoub khalf, M.B.B.CH; 01270127848; Abanoub.khalf@yahoo.com

Contact: Farouk Mourad, Professorship; 01227300925

Sponsors and Collaborators

Assiut University

More Information

Publications:

Yamazaki M, Ikeda Y, Ishikawa M, Inagaki C, Tanaka C. [Inhibition of harmaline induced tremor by L-threo-3, 4-dihydroxyphenylserine, an L-norepinephrine precursor]. Nihon Yakurigaku Zasshi. 1976 Apr;72(3):363-9. Japanese.

Rohner TJ, Hannigan JD, Sanford EJ. Altered in vitro adrenergic responses of dog detrusor msucle after chronic bladder outlet obstruction. Urology. 1978 Apr;11(4):357-61.

Hoffmann MK, Green S, Old LJ, Oettgen HF. Serum containing endotoxin-induced tumour necrosis factor substitutes for helper T cells. Nature. 1976 Sep 30;263(5576):416-7.

Ditta G, Soderberg K, Scheffler IE. Chinese hamster cell mutant with defective mitochondrial protein synthesis. Nature. 1977 Jul 7;268(5615):64-7.

Price P. Monitoring response to treatment in the development of anticancer drugs using PET. Nucl Med Biol. 2000 Oct;27(7):691.

Price NM. Electron beam therapy. Its effect on eccrine gland function in mycosis fungoides patients. Arch Dermatol. 1979 Sep;115(9):1068-70.

Carp H, Janoff A. Possible mechanisms of emphysema in smokers. In vitro suppression of serum elastase-inhibitory capacity by fresh cigarette smoke and its prevention by antioxidants. Am Rev Respir Dis. 1978 Sep;118(3):617-21.

• Responsible Party: Abanoub Khalf Henry Romany, principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03696823
• Other Study ID Numbers: laparoscopic cholecystectomy
• First Posted: October 5, 2018
• Last Update Posted: October 5, 2018
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases