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endoscopic retrograde cholangiopancreatography ( ercp ) is a procedure that combines the use of endoscopy and fluoroscopy to diagnose and treat pancreaticobiliary disorders .
jaundice as a result of biliary obstruction due to choledocholithiasis is one of the most common indications to perform ercp with an intent to perform endoscopic sphincterotomy to facilitate stone removal .
bleeding during ercp typically develops after sphincterotomy , hence patients should be screened and tested for coagulopathy before undergoing ercp .
the presence of any coagulopathy , thrombocytopenia or the use of anticoagulantion therapy are the most important risk factors for bleeding after sphincterotomy .
inherited factor vii ( fvii ) deficiency is a rare autosomal recessive hemorrhagic disorder that can lead to significant coagulopathy and severe bleeding if not appropriately recognized and treated preoperatively .
the use of fvii replacement therapy has been reported to prevent bleeding during surgery in such patients and some reports had limited experience but successful use of recombinant activated fvii ( rfviia ) during a variety of surgical procedures including cesarean delivery , hysterectomy , coronary artery bypass grafting , thoracic surgery , and intracerebral hematoma surgery .
herein we present the first report of a patient with a rare cause of coagulopathy due to inherited fvii deficiency who successfully underwent ercp with sphincterotomy without bleeding where we used recombinant factor viia before and after the procedure .
a 21-year - old female with no known medical illness presented to our hospital with acute right upper quadrant abdominal pain for 2 days .
she denied any history of easy bruising , recurrent epistaxis , excessive bleeding or menorrhagia .
her physical exam revealed no scleral icterus and her abdominal exam revealed right upper quadrant tenderness , non - distended abdomen with no hepatosplenomegaly .
her laboratories were significant for leukocytosis with a white blood cell count of 14.8  10/l , hemoglobin of 12 g / dl , platelet count of 290  10/l , and normal liver chemistry except for alkaline phosphatase of 102 iu / l .
bleeding profile revealed a normal partial thromboplastin time and elevated prothrombin time ( pt ) of 25.3 s ( normal range : 9.5 - 12 s ) and an international normalized ratio ( inr ) of 2.2 ( normal range : 0 - 2.0 ) .
ultrasound of the abdomen revealed cholelithiasis with pericholecystic fluid and gallbladder wall thickening concerning for acute cholecystitis .
magnetic resonance cholangiopancreatography ( mrcp ) revealed a calculus within the dilated cbd which was also confirmed by endoscopic ultrasound ( eus ) examination .
she was given two doses of injectable vitamin k 10 mg and 5 units of fresh frozen plasma ( ffp ) over 48 h with no change in her elevated inr , hence a comprehensive workup for her coagulopathy was performed .
mixing study revealed correction of her pt indicating fvii deficiency rather than the presence of an inhibitor .
there was no evidence of any underlying liver disease and no use of any anticoagulation therapy .
we performed an ercp after giving 2,000 g ( 30 g / kg ) of rfviia ( novoseven rt ) immediately before the procedure , and a sphincterotomy was made with a cook tri - tome sphincterotome ( cook america , winston - salem , nc ) using erbe electrocautery ( fig .
1 ) . there was no post - sphincterotomy bleeding and a stone was successfully removed from the bile duct .
she received another dose of 2,000 g of rfviia 4 h after the procedure to ensure hemostasis and decrease the risk of post - procedural delayed bleeding .
a few days later , she had successful laparoscopic cholecystectomy after giving rfviia before the procedure and no evidence of bleeding was noted during or after the surgery .
a variety of inherited coagulation disorders are associated with clinical bleeding and fvii deficiency is considered a rare disease .
fvii is typically synthesized in the liver and its part of the vitamin k - dependent coagulation factors .
activation of this factor will initiate coagulation via the extrinsic pathway which rapidly activates clotting factor x and initiates the coagulation cascade .
it has a short half - life of 2 - 4 h and is primarily activated by tissue factor ( factor iii ) in response to tissue injury .
genetically , more than 100 mutations have been identified in the fvii gene located on chromosome 13 .
clinically , the disease ranges between an asymptomatic state to lethal hemorrhage and the degree of fvii deficiency does not correlate with the severity of bleeding .
acquired fvii deficiency can be seen in patients receiving warfarin , patients with liver cirrhosis , vitamin k deficiency and rarely due to acquired inhibitors to fvii .
the total number of fvii - deficient patients worldwide is low which explains the lack of large - scale studies in this field . the most predominant feature of the disease is bleeding with variable onset , site , and severity .
the patient may present with epistaxis , hemarthrosis , menorrhagia or excessive bleeding with trauma or invasive procedures .
other features include pregnancy loss , impaired wound healing and interestingly thrombosis with a multifactorial etiology but more attributable to therapy rather than the underlying factor deficiency .
none of the above investigations can predict the perioperative risk of bleeding in these patients . the level of fvii does not always correlate with the risk of bleeding .
the risk of bleeding usually increases with levels of less than 10% and those with > 20% remain frequently asymptomatic .
however , patients with levels > 20% may bleed and those with < 1% may remain asymptomatic .
there are various treatment options to treat hemorrhagic complications which can be also used for prophylaxis prior to surgical intervention and includes administration of fresh frozen plasma ( ffp ) , prothrombin complex concentrate ( pcc ) , fvii concentrate and rfviia .
the best available option is rfviia but it is expensive compared to other options and has limited availability and risk of thrombosis remains a concern .
it can be administered prior to surgery either as a bolus dose or continuous infusion .
there are few trials comparing the efficacy , adverse events and cost effectiveness of pcc and rfviia where the latter was superior .
adverse events associated with rfviia administration include the development of inhibitors against fvii and thrombotic events . recommended dosing of rfviia is 15 - 30 g / kg iv bolus , repeated q4 - 6hr until hemostasis achieved during surgery .
ffp is the least effective therapy and carries risks of transfusion reactions and infections , volume overload and there may be a substantial delay in achieving hemostatic levels of fvii . in this patient ,
5 units of ffp were given over 48 h but without improving her inr preoperatively .
in this case , our patient had fvii deficiency with fvii level of 34% and an inr of 2.2 .
she underwent ercp with successful sphincterotomy after receiving rfviia immediately before the procedure and at 4 h after the procedure to ensure hemostasis and decrease the risk of post - procedural delayed bleeding .
all authors have made contributions to the article and have reviewed it before submission and agree to its publication in this form .
all authors declare that there is no conflict of interest regarding the publication of this paper .
endoscopic retrograde cholangiopancreatography ( ercp ) is a procedure that combines the use of endoscopy and fluoroscopy to diagnose and treat pancreaticobiliary disorders . 
 the risks of ercp include pancreatitis , infection , bleeding and perforation . 
 bleeding during ercp typically develops after sphincterotomy , hence patients should be screened and tested for coagulopathy before undergoing ercp . 
 coagulopathy is a major risk factor for ercp - related bleeding . 
 inherited factor vii ( fvii ) deficiency is a rare autosomal recessive hemorrhagic disorder that can lead to significant coagulopathy and severe bleeding if not appropriately recognized and treated preoperatively . 
 clinically , the disease ranges between an asymptomatic state to lethal hemorrhage and the degree of fvii deficiency does not correlate with the severity of bleeding . 
 the use of fvii replacement therapy has been reported to prevent bleeding during surgery . 
 we present the first report of a patient with a rare cause of coagulopathy due to inherited fvii deficiency who successfully underwent ercp with sphincterotomy without bleeding where we used recombinant factor viia before and after the procedure .