Fistulography is performed to assess the condition of the fistula, and trans-drain occlusion is performed by injecting glue (NBCA and Lipiodol) through the drain to occlude the tract.

Fistulography is performed to assess the condition of the fistula, without trains-drain occlusion.

Pancreatic Fistula

Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
Trans-drain occlusion: a 0.035-inch guidewire is inserted via the puncture needle. The drain tube is removed, cut at 4 cm proximal to the skin fixation site, and preserved for reinsertion. After inserting a 40cm 5Fr KMP catheter over the guidewire, the guidewire is removed. Afte rinsing the KMP catheter with 3ml 5% glucose water, withdraw the catheter and simultaneously inject glue (33%, 1:2, 0.5ml of NBCA + 1ml Lipiodol) into the catheter until the proximal 5cm of the catheter remains inside the tract. The guidewire is re-inserted through the catheter, and then the original drain tube is re-inserted over the guidewire. The guidewire is removed and the drain is fixed.

Fistulography and trans-drain occlusion

Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.

Fistulography

National Taiwan University Hospital

Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial

Days from the randomly allocated treatment to fistula closure

Proportion of patients in whom the drain can be removed by 30 days after occurrence of fistula, without recurrence within the next 3 months

Proportion of patients with fluid collection on follow-up CT, which is to be performed at 3 months after removal of drain or when recurrence of fistula is suspected clinically.

Days from the assigned treatment to discharge

Costs from the assigned treatment to discharge

Proportion of patients who develop fever/infection, ileus, postpancreatectomy hemorrhage from the assigned treatment to end of follow-up.

Fever/infection or pain that develops within 48 hours after the allocated treatment, or any adverse events judged to be related to the treatment

Enrolled patients will be randomly assigned in a 2:1 ratio to receive trans-drain occlusion followed by gradual drain withdrawal or gradual drain withdrawal.

PEGPH20: 3ug/kg on Days 1 and 4
1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15

1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15

PEGPH20: 3ug/kg on Days 1 and 4
1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15
PEGPH20
Gemcitabine
Nab-paclitaxel

Combination Therapy With 1 Week Run-In

1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15
PEGPH20
Gemcitabine
Nab-paclitaxel

Combination Therapy Alone

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Our study will be investigating only clinically relevant pancreatic fistulas, i.e. grades B or C. Descriptive statistics will be used report the incidence of pancreatic fistula within the 7-day post-operative period after neoadjuvant treatment

1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15
PEGPH20

Incidence of Clinically Relevant Pancreatic Fistula

Descriptive statistics with frequency / proportion will be used to evaluate rate of pathologic complete response using the pathological exam of resected tumors. pCR was defined as area of scarring in pancreatic parenchyma and/or peripancreatic soft tissue with chronic inflammation, with or without acellular mucin pools and histiocytic infiltrates, but no residual viable invasive adenocarcinoma cells in the pancreatectomy specimen

Rate of Pathologic Complete Response (pCR)

To evaluate the disease response to treatment, CA19-9 levels will be measured every 4 weeks and restaging Computerized tomography (CT) / magnetic resonance imaging (MRI)of the chest, abdomen and pelvis will be obtained every 8 weeks

Percent Change of CA19-9 Response Rate

Patients will be evaluated for surgical resection depending on imaging obtained on Cycle 4 Day 21. R0 Resection rate determined by CA 19-9 levels will be checked every 4 weeks and restaging CT/MRI of the chest, abdomen and pelvis will be obtained every 8 weeks surgical resection if the patient's tumor is deemed resectable post-therapy. Patients who have received at least 2 complete, 28-day cycles of study drugs were included in the secondary analyses

Margin-Negative (R0) Resection Rate

Descriptive statistics with frequency and proportion of overall response determined by CA 19-9 levels will be checked every 4 weeks and restaging CT/MRI of the chest, abdomen and pelvis will be obtained every 8 weeks

Overall Response Rate (ORR)

Kaplan-Meier methods will be used to analyze disease free survival and median time and 95% confidence intervals will be reported

Disease Free Survival (DFS)

Overall Study

Dr. Andrew Ko

Adenocarcinoma

PEGPH20

Gemcitabine

Nab-paclitaxel

University of California, San Francisco

PEGPH20, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma

Perioperative Stromal Depletion Strategies in Pancreatic Ductal Adenocarcinoma

Andrew Ko

Professor of Clinical Medicine

100 mg of Indomethacin suppository immediately afterwards while still under sedation

suppository of 2.4 g of glycerin immediately afterwards while still under sedation

Post ERCP Acute Pancreatitis

Indomethacin suppository of 100 mg immediately afterwards while still under sedation

Indomethacin

to receive a 2.4 g of glycerin suppository immediately afterwards while still under sedation

2.6-g suppository of glycerin

Department of Gastrointestinal Endoscopy and Department of Gastroenterology of the Specialties Hospital of the Western Medical Center of the Mexican Institute of Social Security.

Indomethacin Decreases Post-ERCP Pancreatitis

Rectal Indomethacin Decreases the Incidence of Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography in High-risk Patients

Defined as the development of new or increased abdominal pain consistent with pancreatitis, and elevated blood amylase or lipase >3 times the upper limit of normal until 24 h after the procedure, and hospitalization (or prolongation of existing hospitalization) for at least 2 nights.

was determined according to consensus guidelines, with mild post-ERCP pancreatitis resulting in hospitalization of < 3 days, and moderate post-ERCP pancreatitis resulting in hospitalization of 4-10 days

Patients who developed Acute Pancreatitis after hospital discharge with presence of abdominal pain consistent with pancreatitis, and elevated blood amylase or lipase >3 times the upper limit of normal.

any amylase level at least three times above the normal serum level in the absence of abdominal pain.

measured in all patients right after procedure and during surveillance (3 hours).

All laboratory exams were performed when acute pancreatitis of any etiology was established

pancreatic fistula/abdominal pain

Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial

PEGPH20, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma

Indomethacin Decreases Post-ERCP Pancreatitis

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