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Intraductal Liposomal Bupivacaine for Chronic Pancreatitis

2021년 7월 15일 업데이트: Johns Hopkins University

Intraductal Liposomal Bupivacaine as a Therapeutic Trial to Determine the Contribution of Peripheral Versus Central Sensitization in the Pathogenesis of Pain in Chronic Pancreatitis- a Pilot and Feasibility Study

The major clinical features of chronic pancreatitis include glandular (exocrine and endocrine) failure and pain. Pain has remained a major clinical challenge and is present in up to 90% of patients and is the primary cause of hospitalization in most patients. Unfortunately, pain in chronic pancreatitis has been very difficult to treat.

The investigators hypothesize that the best method to reliably abolish peripheral nerve signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can best be done during endoscopic retrograde cholangiopancreatography (ERCP).

Since ERCP is done under deep sedation or general anesthesia, it is critical to select a local anesthetic whose effect persists well after recovery from the procedure; if not, the assessment of the effect of the local anesthetic on pain will be impossible to assess. The investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals), which is an FDA approved product for local infiltration that has a longer duration of action (up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma concentrations.

연구 개요

상세 설명

The major clinical features of chronic pancreatitis include glandular (exocrine and endocrine) failure and pain. The former can usually be managed satisfactorily by replacement strategies (enzymes or insulin) to restore nutritional and metabolic stability. However, pain has remained a major clinical challenge and is present in up to 90% of patients and is the primary cause of hospitalization in most patients. Unfortunately, pain in chronic pancreatitis has been very difficult to treat, and the investigators' lack of understanding about the underlying biology has led to various empirical approaches that are often based on purely anatomical grounds, and are generally highly invasive. Significant tissue injury such as that observed in chronic pancreatitis not only triggers nociceptor activation but over time, can also increase the pain in the whole system, a process called sensitization.

Determination of the contribution of peripheral versus central factors to nociceptive sensitization has significant clinical implications in an individual patient. Thus, if pain is caused primarily by signals emanating in the peripheral nerves, then perhaps invasive procedures directed against the pancreas (including pancreatectomy) are justified and can be expected to have a high probability of success. On the other hand, if central sensitization is the dominant pathophysiological factor, then these procedures may cause more harm than good and the patient may be best served using aggressive neuromodulator therapies.

The most direct way to address this question is to interrupt peripheral nerve signaling and determine how much of the pain, if any, is taken away. Unfortunately, there are no satisfactory methods to do this currently. Although celiac or splanchnic nerve blocks have been used for the treatment of pain in chronic pancreatitis, the treatments have had limited success for a variety of reasons, including the fact that the technique may not always be accurate in terms of the site of injection.

The investigators hypothesize that the best method to reliably abolish peripheral nerve signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can best be done during endoscopic retrograde cholangiopancreatography (ERCP), a technique in which the main pancreatic duct is cannulated with the help of a duodenoscope and contrast material injected. This technique is routinely done to assess pancreatic duct anatomy prior to consideration of a therapeutic intervention such as a stent, stricture dilation, or stone removal/lithotripsy.

Since ERCP is done under deep sedation or general anesthesia, it is critical to select a local anesthetic whose effect persists well after recovery from the procedure; if not, the assessment of the effect of the local anesthetic on pain will be impossible to assess. The investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals), which is an FDA approved product for local infiltration that has a longer duration of action (up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma concentrations.

연구 유형

중재적

단계

  • 초기 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Maryland
      • Baltimore, Maryland, 미국, 21287
        • Johns Hopkins Hopital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Signed Informed consent
  • Age >18 years
  • Patients with an established diagnosis of chronic pancreatitis with constant daily pain consistent with the same and not relieved despite standard clinical care for at least 6 months and in whom ERCP is indicated for standard of care.

Exclusion Criteria:

  • Significant liver or renal dysfunction.
  • Any Contraindication of ERCP.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Bupivacaine arm
Participants undergoing ERCP as part of routine clinical care will be consented for this study.

Selective cannulation of the pancreatic duct with ERCP scope will be performed. Any contrast dye used will be carefully aspirated and the duct will be flushed with saline as necessary to clear all residual dye. The canula will be taken to the tail of the pancreatic duct, and gradually withdrawn with slow infusion of the bupivacaine solution. Liposomal bupivacaine (13.3 mg/ml of Exparel) will be injected into the main pancreatic duct for a total of 5-10 ml (depending on the length of the pancreatic duct).

Immediately after the procedure, the patient will be monitored for any evidence of acute pancreatitis (worsening abdominal pain, with amylase or lipase x3 upper limit of normal). The patient will be questioned daily after the procedure for common side effects of bupivacaine including nausea, fever, change in taste, dizziness, weakness, palpitations and loss of taste or any other new or unusual symptom.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in the pain score at 24 hours after ERCP
기간: 24 hours after the ERCP
Raw pain score using a visual analog scale from 0 to 10, being 0 no pain and 10 the worst pain the participant can imagine.
24 hours after the ERCP

2차 결과 측정

결과 측정
측정값 설명
기간
Change in the pain score at 2 hours after ERCP
기간: 2 hours after ERCP
Raw pain score using a visual analog scale from 0 to 10, being 0 no pain and 10 the worst pain the participant can imagine.
2 hours after ERCP
Change in the pain score at 48 hours after ERCP
기간: 48 hours after ERCP
Raw pain score using a visual analog scale from 0 to 10, being 0 no pain and 10 the worst pain the participant can imagine.
48 hours after ERCP
Change in the pain score at 72 hours after ERCP
기간: 72 hours after ERCP
Raw pain score using a visual analog scale from 0 to 10, being 0 no pain and 10 the worst pain the participant can imagine.
72 hours after ERCP

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 7월 1일

기본 완료 (실제)

2021년 7월 1일

연구 완료 (실제)

2021년 7월 1일

연구 등록 날짜

최초 제출

2020년 10월 27일

QC 기준을 충족하는 최초 제출

2020년 10월 27일

처음 게시됨 (실제)

2020년 11월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 7월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 7월 15일

마지막으로 확인됨

2021년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

만성 췌장염에 대한 임상 시험

ERCP with Bupivacaine infusion에 대한 임상 시험

3
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