The inhibitory effect of lidocaine hydrochloride salt on duodenal peristalsis during ERCP:a muiticenter, randomized, placebo-controlled trial.

JRCT ID: jRCTs031190059

Registered date:23/07/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute cholangitis,Obstructive jaundice,Pancreatic cancer,IPMN
• Date of first enrollment: 07/10/2019
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Investigational product:To spray A(2% lidocaine hydrochloride 10ml+normal saline solution 10ml) for papilla
Control drug:To spray B(PG water EJ 10ml+normal saline solution 10ml) for papilla

Outcome(s)

• Primary Outcome: Ceased peristalsis
• Secondary Outcome: Required time,Stop duration time,Adverese events

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1.over the age of 65 under the age of 90
2.Adaptation of ERCP
3.Score of peristalsis 1-3
4.Written informed consent

Exclude criteria

1.Acute pancreatitis
2.Allergy of Amide-type local anesthetic allergy
3.Altered upper GI anatomy
4.Pregnant,unwilling to practice contraception during the study, or lactating female
5.Heart stimulus conduction disorders
6.severe liver or kidney dysfunction
7.score of peristalsis:4,5
8.A patient who has judged to be inappropriate as a target by the judgement of the practitioner

Related Information

• Primary Sponsor: Kurita Yusuke