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Consecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer complaining of pain due to pancreatic duct obstruction will receive a pancreatic duct stent.

Pancreatic Duct Stent Placement

Mouen Khashab, MD

This research is being done to assess the effects of pancreatic duct stenting on relief of obstructive pain (pain due to outflow obstruction of main pancreatic duct) caused by pancreatic cancer.

Although most people with pancreatic cancer (80-85%) suffer distressing pain, it is poorly controlled. Currently, medical management has been focused on frequent use of opioid painkillers (narcotics) which are associated with several complications. Pain in pancreatic cancer is mainly caused by tumor invasion to nerves near pancreatic gland, but in certain patients with pancreatic cancer, pain is believed to be obstructive in nature and is due to outflow obstruction of main pancreatic duct (PD) which extracts pancreatic secretions. This kind of pain is specifically marked by pain occurring after eating. With this respect, decompression of pancreatic duct has been associated with pain relief in people with chronic inflammation of pancreas due to obstruction of its main duct (chronic pancreatitis). Therefore; we think that it might be beneficial in the management of obstructive pain in people with pancreatic cancer.

Endoscopic stenting of pancreatic duct is a way for decompression and appears to be effective and safe palliative (pain relief) treatment for pain management in patients with chronic pancreatitis. Besides safety, pancreatic stenting seems to be associated with a significant decrease in amount of required opioids and analgesic drugs (and their side effects) for pain management, and may improve patients' quality of life. There are only a few old reports about beneficial effects of endoscopic pancreatic duct decompression for relief of obstructive pain in pancreatic cancer. Currently, we have improved stents. Since prior clinical practice has shown that pain improves, we plan to place stents with the expectation that pain will improve. We hope that it will decrease need for recurrent hospitalizations for pain control and decrease in need for medications (narcotics) and medication side effects, and also will improve the quality of life. Specific instruments will be applied as research tools to monitor pain score and quality of life before and after pancreatic duct stenting in this study.

Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer

Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients: A Prospective Pilot Study

The severity of abdominal pain assessed by visual Analog Scale (VAS) score ranging from 0 (no pain)-10 (the most severe pain). This will be measured at baseline (before procedure), and at 1 week, 4 weeks, 12 weeks, and 6 months after procedure

Related complications within 30 days of endoscopic therapy will be recorded.

Categorized as: ''complete pain relief,'': the patient has no residual pain; ''major pain relief,'': the patient still experiences weak or occasional episodes of pain, with a maximum of 3 of 10 on the pain scale, or a reduction by at least 3 points on the same scale compared with before the procedure; and ''absence of pain relief,'': there is only minor or no improvement of the pain pattern

Defined as pain free days after procedure. This will also be defined prior to the procedure.

Determine improvement in QOL of patients after PD stenting. QOL will be assessed using a specific instrument for patients with pancreatic cancer, the EORTC-QLQ-Pan26 instrument, at baseline, 4 and 12 weeks and 6 months after procedure.

Required opioids dose will be documented before and 1, 4, and 12 weeks after procedure. Both scheduled and PRN (as needed) doses will be recorded before and after procedure. Dose adjustment will be carried as per standard clinical practice.

Time required from introduction of the upper endoscope until placement of the PD stent.

Success of stent placement in the desired location as determined endoscopically and radiographically.

Determine PD patency which is defined as time period between stent placement and need for re-intervention due to stent obstruction or stent migration.

The severity of pancreatitis will be classified according to Cotton's criteria as: mild if additional hospitalization for 1-3 d is required; moderate if additional hospitalization for 4-10 day is required; and severe if hospitalization for more than 10 d is needed, as well as in cases of hemorrhagic pancreatitis, phlegmon, or pseudocyst

Any need for operation after endoscopic therapy.

Johns Hopkins University

Official Title: Assistant Professor of Medicine; Director of Therapeutic Endoscopy

Insulinoma

Adenoma

Adenoma, Islet Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery.

Patients will receive enucleation surgery directly following normal procedure

Advance placement of pancreatic stents endoscopically

placement of pancreatic duct stents before enucleation surgery

Patients will receive direct enucleation surgery

Direct enucleation surgery

Qiang Xu, Doctor

The purpose of this study is to compare the clinical efficacy and economic cost of enucleation after placement of pancreatic duct stents before surgery with that of direct enucleation alone, and to evaluate its safety and feasibility.

The research contents of this study include: patients with insulinoma near the main pancreatic duct in the head and neck of the pancreas were randomly divided into two groups: the preoperative pancreatic duct stent enucleation group (stended EN), the direct en group (DEN), the Sen group asked a digestive endoscopist to place the pancreatic duct stent before surgery, and the next day or the next day after surgery, and the den group received enucleation directly. The safety of the two groups was compared, including the evaluation of surgical effect Postoperative complications and long-term prognosis based on follow-up data analysis; At the same time, the differences between the two groups were evaluated from the perspective of health economics.

Outcome assessors are kept blinded to participant group allocation. Objective clinical data are provided to independent assessors with blindness of allocation. With clear definition for each endpoints, assessors are able to make grading for complications in primary and secondary endpoints

A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct

Data obtained through this study may be provided to qualified researchers with academic interest in the surgical treatment of insulinoma. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Postoperative clinically relevant pancreatic fistula in this study adopts the definition proposed by the international pancreatic surgery research group (ISGPS)

Abdominal infection can be basically diagnosed if one of the following conditions occurs:

1. After 3 days of operation, the patient developed chills, high fever, abdominal distension, intestinal paralysis, etc., which lasted for more than 24 hours. The laboratory examination results showed that the leukocyte count increased significantly, with or without hypoproteinemia and anemia, and the imaging images showed the accumulation of fluid in the abdominal cavity;
2. The aspiration fluid was purulent or bacteria were detected in the fluid;
3. The infection was localized and formed inclusion. In imaging, fluid accumulation foci with clear edges and with or without gas could be seen.

Gastric emptying disorder can be diagnosed if the solid diet cannot be restored 1 week after operation and the gastric tube cannot be removed.

Postoperative hemorrhage refers to the occurrence of bloody fluid in the abdominal drainage tube or gastrointestinal decompression tube, which can also be manifested as blood in the stool, accompanied by changes in vital signs such as heart rate and blood pressure, as well as a decrease in hemoglobin concentration.

According to Rome IV standard, the diagnosis should meet the following requirements:

Symptoms appear for at least 2 months, and must include one or more of the following uncomfortable symptoms, and at least 4 times a month:

a. fullness after meals; b. Early satiety; c. Epigastric pain or burning sensation has nothing to do with defecation; d. After proper evaluation, the symptoms cannot be completely explained by other disease conditions.

Patients with any of the following conditions:

a. continuous fever or leukocytosis, accompanied by postoperative chest X-ray or chest CT positive findings (consolidation of lung, pneumonia, atelectasis, with or without pleural effusion), and decreased body temperature after antibiotics; b. Sputum culture is positive, accompanied by continuous fever or leukocyte elevation, and body temperature drops after antibiotics; c. Pleural effusion affects the patient's breathing and requires pleural puncture and drainage.

the diagnosis should meet at least one of the following requirements:

a. hemoglobin A1c (HbA1c) value ≥ 6.5%; b. If the fasting blood glucose is ≥ 126mg / dl, the test should be repeated on another day. Fasting is defined as at least 8 hours without calorie intake; c. Oral glucose tolerance test (OGTT), plasma glucose ≥ 200 mg / dl at 2 hours after 75g (100g for pregnant women) glucose load; d. Hyperglycemic symptoms and accidental (random) plasma glucose ≥ 200mg / dl.

Patients with any two of the following three criteria can be diagnosed : a. abdominal pain consistent with the onset; b. Biochemical evidence of pancreatitis (serum amylase and / or lipase greater than 3 times the upper limit of normal); c. Typical manifestations of abdominal image (pancreatic edema / necrosis or exudation and effusion around the pancreas)

Peking University First Hospital

Xuanwu Hospital, Beijing

First Affiliated Hospital Xi'an Jiaotong University

Ruijin Hospital

Peking Union Medical College Hospital

performed pancreatic duct stent placement after endoscopic papillectomy

have not performed pancreatic duct stent placement after endoscopic papillectomy

performed common bile duct stent placement after endoscopic papillectomy

have not performed common bile duct stent placement after endoscopic papillectomy

Post-resection, endoscopic retrograde cholangiopancreatography (ERCP) was performed for stent placement in pancreatic or bile ducts as needed, with X-ray confirmation of stent positioning.

Stent Placement in Pancreatic and Bile Ducts

Fujing Lv, M.D.

This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates.

Duodenal papillary adenoma, a potentially malignant benign tumor is primarily treated with endoscopic papillectomy. Despite its efficacy, endoscopic papillectomy has a high complication rate. This study investigates whether pancreatic duct and common bile duct stent placement can mitigate these complications. In a retrospective analysis, 79 patients with duodenal papillary adenoma, treated with endoscopic papillectomy at our center, were studied. The cohort included patients who underwent endoscopic papillectomy with no stents placement, common bile duct stent placement alone, pancreatic duct stent placement alone, or stents placement in both ducts. Complete resection rates did not significantly differ between patients with or without stent placement. Early complication rates were similar across groups. However, significant reduction in common bile duct stenosis was observed in the stenting group. Furthermore, stent placement correlated with lower adenoma recurrence rates during follow-up. Thus, Pancreatic duct and common bile duct stent placement in endoscopic papillectomy may decrease late complications, particularly common bile duct stenosis, and reduce the recurrence of duodenal papillary adenoma.

Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma

Effectiveness of Endoscopic Papillectomy With Stent Placement in Pancreatic and Bile Ducts for Treating Duodenal Papillary Adenoma

Complications related with Endoscopic Papillectomy (EP), including pancreatitis, cholangitis, bleeding, perforation, hyperamylasemia, stenosis. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination during follow-up were measured.

The pathological margins results were used to determine whether the lesion was completely resected.

Endoscopic observation and biopsy results were used to find recurrence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer	NCT01895790	Pancreatic Canc...	Pancreatic Duct...	18 Years - 80 Years	Johns Hopkins University
Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer	NCT01895790	Pancreatic Canc...	Pancreatic Duct...	18 Years - 80 Years	Johns Hopkins University
A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct	NCT05523778	Insulinoma	placement of pa... Direct enucleat...	18 Years - 75 Years	Peking Union Medical College Hospital
Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma	NCT06301048	Duodenal Adenom... Complication of...	Stent Placement...	18 Years -	Beijing Friendship Hospital

Spots Global Cancer Trial Database for pancreatic duct stent