Assessing the Feasibility and Acceptability of Additional Pancreatic Nerve Plexus Neurotomy for Pain Management in patients undergoing Surgery for Chronic Pancreatitis- A Non-Randomized Interventional (PILOT) Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the feasibility of Therapeutic Pancreatic Nerve Plexus Neurotomy in addition to Surgery in patients with Chronic Pancreatitis
研究概览
简要总结
In patients known to have chronic pancreatitis, relapsing upper abdominal pain is the main reason to seek surgical treatment. The purpose of surgical therapy is to relieve symptoms, especially pain, and to improve the patient’s quality of life. Several medical, endoscopic and surgical treatment strategies have been employed in routine practice for the purpose of treatment of the disease. Although surgical approach to chronic pancreatitis has been quite successful, management of patients with intractable pain from chronic pancreatitis has been difficult, often resulting in narcotic addiction and/or malnutrition from major pancreatic resections. In regard to this, a novel approach of Therapeutic Surgical Neurotomy in addition to Routine Standard surgery can be considered beneficial. Simple denervation of the pancreatic head nerve plexus fibers offers a logical approach of pain relief in chronic pancreatitis. In view of the same, no studies have been conducted on chronic pancreatitis assessing the feasibility of Therapeutic Neurotomy of Pancreatic Nerve Plexus as an adjunct to Standard Surgical Procedures in patients with Chronic Pancreatitis. This novel study thus aims to provide greater insights into the combined approach on Pain Relief, which being the most significant debilitating factor for patients with Chronic Pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Inclusion Criteria- Patients undergoing Surgical Procedure for Chronic Pancreatitis and satisfying the following criteria- ADULT age-group i.e., 18-65 years.
- •Duration of illness more than 2 years.
- •IZBICKI Pain Score more than 50.
排除标准
- •• Individuals with Pseudocyst, Walled-Off Necrosis, Recent attack of Acute Pancreatitis (4 weeks), Obstructive Jaundice, Pancreatic Mass/Lesion (suspected malignancy) • Patient with Psychiatric Illness • Patients denying consent.
结局指标
主要结局
To assess the feasibility of Therapeutic Pancreatic Nerve Plexus Neurotomy in addition to Surgery in patients with Chronic Pancreatitis
时间窗: Baseline (at time of intervention)
次要结局
- To compare the effects of Therapeutic Pancreatic Nerve Plexus Neurotomy in addition to Surgery on reduction in Izbicki Pain Score & the Quality-of-Life in patients with Chronic Pancreatitis.
研究者
DR SOMNATH MUKHERJEE
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY
