Is the Isolated-Tip Needle-Knife Precut as Effective as Conventional Precut Fistulotomy in Difficult Biliary Cannulation?

BACKGROUND/AIMS: Needle-knife precut fistulotomy (NK-F) is a well-known freehand technique for difficult biliary cannulation (DBC). Another approach involves the use of Iso-Tome®, a modified precutting device with an insulated needle tip to prevent direct thermal injury. This comparative study aimed to evaluate the efficacy of the Iso-Tome® precut (IT-P) compared to that of NK-F for DBC. METHODS: Patients with a naive papilla who underwent early IT-P or NK-F for DBC were enrolled. DBC was defined as failure to achieve selective biliary access by wire-guided cannulation despite 5 minutes of attempted cannulation, ≥5 papillary contacts, or a hook-nose-shaped papilla. The primary endpoint was the primary technical success rate, which was based on a noninferiority model. RESULTS: A total of 239 DBC cases were enrolled. The primary technical success rates were 74.7% (89/119) in the IT-P group and 91.6% (110/120) in the NK-F group (lower limit of 90% confidence interval, −0.23; p=0.927 for a noninferiority margin of 10%). The total technical success rates were 87.4% and 95.0%, respectively (p=0.038). The mean precutting times for successful biliary access were 11.2 minutes for IT-P and 7.3 minutes for NK-F (p < 0.01). The procedure-related adverse event rates were 9.2% for IT-P and 5.8% for NK-F (p=0.318). The rates of post-endoscopic retrograde cholangiopancreatography pancreatitis were 4.2% and 2.5%, respectively (p=0.499). CONCLUSIONS: IT-P failed to exhibit noninferiority compared with NK-F regarding the primary technical success rate of DBC, but there was no difference in the frequency of adverse events.

New Technique of Endoscopic Sphincterotomy with Iso-Tome(R) to Incise the Distal Papillary Roof in Patients with Choledocholiths and Choledochoduodenal Fistula

BACKGROUND/AIMS: It is sometimes difficult to incise the distal papillary roof (PR) completely in patients with choledocholiths and choledochoduodenal fistula (CDF). The Iso-Tome(R) (MTW-Endoskopie W. Haag KG), which is helpful in preventing electrical leakage, has good orientation capabilities and can be easily placed at the orifice of the CDF or ampulla of Vater (AV). We aimed to evaluate the efficacy of endoscopic sphincterotomy (ES) with the Iso-Tome(R) for cutting the distal PR. METHODS: Between May 2003 and July 2012, 35 patients were analyzed retrospectively. The distal PR was cut downward and/or upward using the Iso-tome(R) until the pink intrapapillary mucosa was fully exposed. Downward incisions were performed from the opening of the CDF to the orifice of the AV; upward incisions were performed in reverse. RESULTS: Spontaneous or artificial CDF occurred in four and 31 patients, respectively. The technical and therapeutic success rates were 94.3% (33/35) and 94.3% (33/35), respectively. There was no case of electrical damage to the pink intrapapillary mucosa. Adverse events occurred in 2.9% (1/35; 1, mild bleeding) of patients. CONCLUSIONS: The new technique of ES with the Iso-tome(R) is feasible and useful for effectively incising the distal PR in patients with CDF and choledocholiths.

New Technique of Endoscopic Sphincterotomy with Iso-Tome(R) to Incise the Distal Papillary Roof in Patients with Choledocholiths and Choledochoduodenal Fistula

BACKGROUND/AIMS: It is sometimes difficult to incise the distal papillary roof (PR) completely in patients with choledocholiths and choledochoduodenal fistula (CDF). The Iso-Tome(R) (MTW-Endoskopie W. Haag KG), which is helpful in preventing electrical leakage, has good orientation capabilities and can be easily placed at the orifice of the CDF or ampulla of Vater (AV). We aimed to evaluate the efficacy of endoscopic sphincterotomy (ES) with the Iso-Tome(R) for cutting the distal PR. METHODS: Between May 2003 and July 2012, 35 patients were analyzed retrospectively. The distal PR was cut downward and/or upward using the Iso-tome(R) until the pink intrapapillary mucosa was fully exposed. Downward incisions were performed from the opening of the CDF to the orifice of the AV; upward incisions were performed in reverse. RESULTS: Spontaneous or artificial CDF occurred in four and 31 patients, respectively. The technical and therapeutic success rates were 94.3% (33/35) and 94.3% (33/35), respectively. There was no case of electrical damage to the pink intrapapillary mucosa. Adverse events occurred in 2.9% (1/35; 1, mild bleeding) of patients. CONCLUSIONS: The new technique of ES with the Iso-tome(R) is feasible and useful for effectively incising the distal PR in patients with CDF and choledocholiths.

Feasibility of the Mucosa-Tracking Technique in Precut Papillotomy with the Iso-Tome as an Alternative to the Needle-Knife Technique

BACKGROUND/AIMS: The aim of this study was to evaluate whether the mucosa-tracking technique is effective for improving precutting-related pancreatitis and the sustained failure of bile duct cannulation in precut papillotomy (PP) with the Iso-Tome (MTW Endoskopie). METHODS: From September 2004 to June 2006, PP was performed with the Iso-Tome if biliary cannulation failed by conventional methods for approximately 5 minutes. The pink intrapapillary mucosa (PIPM) exposed by PP was tracked and classified into four groups: fully exposed and oriented to the direction of the bile duct (group A) or the pancreatic duct (group B), partially exposed (group C), or unexposed (group D). The success rate of bile duct cannulation (SRBC), the procedure time required for successful bile duct cannulation (PTBC), and the complications in the first session were compared between the mucosa-exposed groups (MEGs; group A, B, and C) and the mucosa-unexposed group (MUEG; group D). RESULTS: A total of 59 patients (25 females, 34 males) with a mean age of 65.2 years were enrolled. The MEGs and MUEG comprised 52 (88.1%) and 7 (11.9%) patients, respectively. SRBC in the first session was 86.4% (51/59) in total and 92.3% (48/52) in the MEGs, compared to only 42.9% (3/7) in the MUEG (p=0.005). The mean PTBC in the MEGs and MUEG was 8.7 minutes and 16.3 minutes, respectively (p=0.23). Complications occurred in 6.8% of the patients (4/59; all pancreatitis); there were no differences between the MEGs (5.8%, 3/52) and MUEG (14.3%, 1/7; p=0.41). All four patients with pancreatitis were managed medically. CONCLUSIONS: The mucosa-tracking technique in PP with the Iso-Tome is a feasible and useful method of enhancing SRBC. PIPM is an important endoscopic landmark for successful PP.