RCT of the Double Wire Technique for Sphincterotomy

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

Official title:

A Randomized Controlled Trial of the Double Wire Technique With or Without Transpancreatic Sphincterotomy for Difficult Common Bile Duct Cannulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01792466
• Other study ID #: 12-007021
• Status: Terminated
• Phase: N/A
• First received: February 11, 2013
• Last updated: July 17, 2017
• Start date: February 2013
• Est. completion date: November 2016

Study information

• Verified date: July 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening.

Therapy on the biliary tree, like for example stone removal, frequently requires inserting tools through the opening of the duct and cutting of the muscle which control the secretion of juices from the liver. Cutting the muscle helps with securing an easy access to the bile duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly because it straightens the duct. On certain occasions this also fails and we resort to cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile duct. The more attempt to enter the bile duct the higher the risk of inflammation in the pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct opening. The study is trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct immediately after a wire has entered the pancreatic duct will make it easier to place the wire in the bile duct as compared to trying to place the wire in the bile duct without cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting the pancreatic muscle will facilitate entry to the bile duct and decrease the number of attempts at entering the bile duct then it might be a better way to approach the patient whom we had difficulty in entering the bile duct.

Description:

This will be a prospective, non blinded randomized controlled trial. We will screen and offer enrollment to all patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla and an indication for cholangiography and sphincterotomy. Informed consent will be obtained in the preoperative area after obtaining consent for the ERCP. We will randomize all patients in whom we fail to deeply cannulate the CBD using a sphincterotome (Autotome, Boston Scientific) and 0.035" guidewire (0.035" Jagwire or Dreamwire, Boston Scientific) in over 5 minutes or with more than 5 attempts and in whom the wire can be passed in a stable configuration in the Pancreatic duct (PD). We will exclude patients who have any contraindication to undergoing an ERCP, contraindications to sphincterotomy (e,g,, abnormal anatomy, uncorrectable coagulopathy) and those who have pancreas divisum. Patients will be randomized 1:1 using opaque envelopes in blocks of 4 stratified for gender. (Gender stratification is necessary as the risks of ERCP vis pancreatitis are different for males and females). In those randomized to the DWT group, the PD wire will be left in place, the catheter removed and then reinserted next to the PD wire with a second wire to attempt CBD cannluation as previously described (1). In those randomized to TPS, a pancreatic sphincterotomy will be performed with the sphincterotome. The catheter will be removed with the PD wire left in place. The catheter and a second wire will be inserted and CBD cannluation attempted as for the DWT group. All patients will receive a 5Fr pancreatic stent and indomethacin 100 mg rectally to reduce the risk of pancreatitis as per our standard of care (patients with contraindications to NSAIDs (e.g., sensitivity to Indomethacin, aspirin or class, active peptic ulcer disease) will not receive Indomethacin. Patients who fail DWT (at least 10 minutes or 10 further attempts) may be crossed over to TPS at the endoscopist's discretion. Further care the patients receive will be standard of care. We will contact the patients around a months later by telephone to ask about any procedure related complications that were not reported to us.

outcome measures will be assessed on day 1 at the end of the procedure and on day 30.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion criteria

1. All patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla

2. Failure to deeply cannulate the CBD in over 5 minutes and with more than 5 attempts

3. Stable wire placement into the Pancreatic duct (PD) exclusion criteria

1. Any contraindication to undergoing an ERCP. 2. Contraindications to sphincterotomy. 3. Pancreas divisum.

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Sphincterotomy, Endoscopic
• VATER'S AMPULLA

Intervention

Procedure:
• Transpancreatic sphincterotomy
A sphinctertome will be placed into the pancreatic duct over a guidewire and the sphincter will be cut in the direction of the bile duct

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of attempts needed to achieve deep cannulation with a second wire.	Number of attempts needed to achieve deep cannulation with a second wire.	Day one
Secondary	Time from randomization to deep cannulation.	Time from wire stable in the pancreatic duct until the second wire enters the bile duct	day of the procedure