Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Fistula

Pathological Conditions, Anatomical

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

ERCP guided stent insertion before transection of the gland

stent

Distal pancreatectomy

Urban Arnelo

Farshad Frozanpor

Lars Lundell, Professor

Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.

Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.

B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.

Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.

Karolinska Institutet

Karoliska instuitut

Neuroendocrine Tumors

Pancreatitis

Pancreatitis, Chronic

Pancreatic Fistula

Pancreatic Pseudocyst

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Chronic Disease

Disease Attributes

Digestive System Fistula

Cysts

Pancreatic Cyst

Chronic Graft Versus Host Disease

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.

Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples.

Stapling closure of the pancreatic stump

Roux-en-Y anastomosis of the pancreatic stump

Manabu Kawai, MD

The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.

The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.

Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.

The primary endpoint in this trial was defined as the incidence of pancreatic fistula .

Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy

Osaka University

Nara Medical University

Kyoto Prefectural University of Medicine

Kansai Rosai Hospital

Hyogo Medical University

Wakayama Medical University

Second Department of Surgery

Central Nervous System Depressants

Pharmaceutical Solutions

Vasoconstrictor Agents

Respiratory System Agents

Cardiotonic Agents

Central Nervous System Stimulants

Other Dietary Supplements

Anesthetics

Oxymetazoline

Phenylephrine

Ephedrine

Pseudoephedrine

Benzocaine

Tannic Acid

All patients will receive Normosol or equivalent solution, 0.5 ml/kg/fasted hour IV (approximately from 8am to time of induction) during induction of anesthesia. All patients will then receive maintenance fluids consisting of Normosol or equivalent solution at 6 ml/kg/operative hour. After randomization occurs, those patients randomized to the Restricted Arm will continue to receive Normosol or equivalent solution at 6ml/kg/operative hour.

All patients will receive Normosol or equivalent solution, 0.5 ml/kg/fasted hour IV (approximately from midnight to time of induction) during induction of anesthesia. All patients will then receive maintenance fluids consisting of Normosol or equivalent solution at 6 ml/kg/operative hour. Those patients randomized to the Liberal Arm will receive an additional Normosol bolus or equivalent solution equal to (another) 1.5 ml/kg/fasted hour IV (to bring the total to 2 ml/kg/fasted hour) plus an additional bolus of Normosol or equivalent solution 6ml/kg/operative hour to bring the hourly rate to 12ml/kg/operative hour with a maximum of 1000 ml/operative hour.

Normosol or equivalent solution 0.5 ml/kg/fasted hour IV (8am to time of induction) during induction of Anesthesia. Maintenance IV Normosol or equivalent solution at 6 ml/kg/operative hour. Blood loss to be replaced volume: volume with colloid until transfusion criteria met. Additional fluid boluses of 100ml Normosol or equivalent solution or bolus pressors (phenylephrine 40mcg or ephedrine 5mg) at the discretion of the Anesthesiologist to maintain patient hemodynamic stability.

restrictive perioperative fluid management

Normosol or equivalent solution 0.5 ml/kg/fasted hr IV (8am to time of induction) of Anesthesia. Maintenance IV Normosol or equiv solution at 6 ml/kg/oper hr. At randomiz to the Liberal arm in the OR, an addit bolus of Normosol or equiv solution 1.5 ml/kg/fasted hr IV (8am to time of induction) will be given to bring the total to Normosol or equiv solution 2ml/kg/fasted hr IV (8am to time of induction). Pt will get an addit bolus of Normosol or equivalent solution 6ml/kg/oper hr. Maintenance IV Normosol or equivalent solution will then commence at 12ml/kg/operative hr with maximum of 1000 ml/operative hr. Blood loss replaced volume: with colloid, until transfusion criteria met (Additional fluid boluses of 100ml Normosol or equivalent solution or bolus pressors (phenylephrine 40mcg or ephedrine 5mg) used at the discretion of the Anes to maintain pt hemodynamic stability. Addit fluid boluses of 250ml Normosol or equivalent solution for urine output less than 1ml/kg for 2 hrs.

Liberal perioperative fluid management

Florence Grant, MD

The purpose of this study is to help us learn what the best amount of fluid is that patients should receive during pancreas surgery. Patients will receive either the liberal fluid amount for this surgery or a restricted fluid amount.

Both amounts of fluid have been used safely in patients having similar surgeries. These amounts have not been compared in pancreatic surgery. The fluids regimens that will be given are not experimental.

This study will compare patients in the liberal and restricted fluid groups in terms of the nature of any surgical complications (problems)and recovery from surgery, including length of hospital stay.

Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection

A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection

Memorial Sloan Kettering Cancer Center

MVR: Multivisceral resection was considered when the exeresis of an organ other than the pancreatic body-tail and / or spleen was performed.

Multivisceral resection was considered when the exeresis of an organ other than the pancreatic body-tail and / or spleen was performed.

José Manuel Ramia, MD, PhD

The objective of the study is to evaluate the characteristics of the patients and the results of morbidity and mortality after distal pancreatectomy isolated or accompanied by multivisceral resection including cholecystectomy.

Multicenter study that includes patients operated on for distal pancreatectomy between January 2009 to December 2019 for primary pancreatic tumors. Both open or laparoscopic approaches are considered in the study. The objective is to evaluate the characteristics of the patients and the results of morbidity and mortality after distal pancreatectomy isolated or accompanied by multivisceral resection including cholecystectomy. For this, demographic data, variables related to the tumor, surgical intervention and postoperative evolution were collected.

Definitions:

Diagnosis was based mainly on computed tomography (CT scan), Magnetic Resonance (MRI) and endoscopic ultrasonography (USE) plus biopsy. Surgical technique includes open and laparoscopic approach with or without spleen preservation. Complications were assessed at 90 days using the Clavien - Dindo classification, and those defined as Clavien - Dindo grade IIIA or higher were considered major. For the recording of complications, the medical and nursing notes of the electronic or histories of each patient were consulted. For the specific complications of pancreatic surgery, the definitions of the International Study Group on Pancreatic Surgery (ISGPS) of delayed gastric emptying (21), post-pancreatic hemorrhage (22) and pancreatic fistula were used. The resection margins of the surgical specimen were categorized according to the definitions of the Royal College of Pathologists: R0 (margin to the tumor ≥ 1mm), R1 (margin to the tumor \<1mm) and R2 (macroscopically positive margin) (24). Tumors were staged according to the TNM classification 8 º Ed. (TNM). Follow up scheme was: 6-month outpatient clinic visit during first five years including tumoral markers and CT/MRI. After five years only once a year visit policy was applied.

Variables The following variables were studied: Epidemiological: age, sex, past medical history, medication, Charlson Index and American Society of Anesthesiology (ASA) classification; Clinical: symptoms due to mucinous neoplasm (MCN); Serological tests: leukocytes, amylase; hemoglobin (gr/dl), bilirubin, creatinin, prothrombin time, carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 19-9; Radiological/diagnostic: diagnostic tests performed (CT/MRI/EUS), number, size and location of MCN, vascular infiltration (arterial and venous) and preoperative biopsy; Surgical: type of approach (open/laparoscopy/conversion), spleen preservation, associated procedures (organs resected), type of closure of pancreatic remnant, intraoperative bleeding (ml); postoperative course: morbidity and mortality (according to the Clavien-Dindo (CD) classification) (13), pancreatic fistula, postoperative hemorrhage and delayed gastric empting, if present, was classified according to the International Group Study Pancreatic Surgery (IGSPS) classification (14,15), hospital stay and readmissions. The histological data retrieved were TNM: tumor size and lymph nodes harvested and R status. Postoperative follow-up (months) including endocrine and exocrine insufficiency rate.

Multivisceral Resection in Distal Pancreatectomy

Distal Pancreatectomy With Multivisceral Resection: A Multicentric Study

The study data will be available upon request to the principal investigator via e-mail.

Any complication in the postoperative period

If the patient dies in the postoperative period

Universidad de Extremadura

Chief of department

Patients who will not receive intraperitoneal drainage following pancreas resection.

Patients who will receive drains, the standard of care treatment, following pancreas resection.

A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.

No Drains

A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).

Drains

William E Fisher, MD

This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.

The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have traditionally placed drains near the pancreatic anastomosis to control this potentially very serious complication. In recent years, advances in interventional radiology have allowed safe percutaneous drainage of intra-abdominal fluid collections. Some surgeons have abandoned the routine use of prophylactic drains placed at the time of pancreas resection and rely on percutaneous drainage for the minority of patients who develop a pancreatic fistula.

Hypothesis:

This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery. The primary endpoint to assess the severity of complications will be the number of patients with any ≥ Grade II complication. Severity of complications experienced will also be assessed by comparing the number of patients with, any ≥ Grade III complication, any serious adverse event (SAE), and the median complication severity grade of all complications. The frequency of complications will be assessed by comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any severity grade.

Objectives:

Primary: Difference in 60-day ≥ Grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

Secondary:

A. 60-day ≥ Grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

B. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

C. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

D. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

E. 60-day, and 90-day mortality rate comparison between patients who receive a pancreatetomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

F. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

G. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

H. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

I. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

Pancreas Resection With and Without Drains

A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage

The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics.

This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced

This is the median number of complications per patients.

The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0).

This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported.

This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis.

Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis.

The Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0\~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0\~144. A lower score represents the worst quality of life.

Baylor College of Medicine

Director, Elkins Pancreas Center, Professor, Michael E. DeBakey Department of Surgery

Patients did not receive intraperitoneal drainage following pancreas resection.

No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.

Patients did receive drain(s), the standard of care treatment, following pancreas resection.

Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

A potential weakness of the current study is that it took 5 years to reach targeted accrual.

Amy McElhany, Clinical Research Manager

the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.

60-day ≥ Grade II Complication Rate

60-day ≥ Grade III Complication Rate

Serious Adverse Event (SAE) Rate

All patients

For just the patients with complications

Median Complication Severity Grade

60-day Frequency of Complications

90-day Mortality Rate

Pancreatic_leak_fistula

Postoperative_Abdominal_FluidCollection

Biliary_leak

Enteric_leak

Lymph_Leak

Diarrhea

Gastroparesis_DelayedGastricEmptying

SmallBowelObstruction

Seroma

Intra_abd_abscess

Wound_Dehiscence

Wound_Infection

Fever

Patients who will not receive intraperitoneal drainage following pancreas resection.

No Drains: A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.

Patients who will receive drains, the standard of care treatment, following pancreas resection.

Drains: A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).

Rate of Specific Complications

Length of Stay for the Index Admission

Crude Cost

Physical well-being subscale

Social/Family well-being subscale

Emotional well-being subscale

Functional well-being subscale

Total FACT-G score

FACT-Pa subscale

Total FACT-Pa score

The result is the quality of score at 30 days.

Composite Quality of Life Scores

Overall Study

Adenocarcinoma

Recurrence

Patients undergone curative distal pancreatectomy for PDAC who developed POPF

Patients undergone curative distal pancreatectomy for PDAC who did not develop POPF

Fabrizio PANARO, PhD

Clinically-relevant post-operative fistula is a major complication after DP, but it did not affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.

POPF is the most common and feared complication after distal pancreatectomy (DP), increasing morbidity and mortality. Recent evidences suggest that POPF can also play a role in pancreatic cancer recurrence. Adult patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) of the body and tail of the pancreas, undergoing curative DP, over a ten-year period in twelve European Surgical Departments were retrospectively collected from a prospective implemented database. Cohort studied included 283 patients, 139 were men (49.1%), median age was 70 years-old (range 37-88). A total of 121 POPF were observed (42.8%), 42 of them (14.9%) were CR-POPF. Median follow-up period was 24 months (range 3-120). Although poorer in the POPF group, overall survival (OS) and disease-free survival (DFS) did not differ significantly when comparing patients with and without CR-POPF (p= 0.224 and p= 0.165, respectively). CR-POPF was not significantly associated with local or peritoneal recurrence (p=0.559 and p=0.302, respectively). Less patients after POPF (76.2% versus 83.8%) benefited from adjuvant chemotherapy but the difference was not significant (p=0.228). CR-POPF is a major complication after DP, but it did affect neither the post-operative therapeutic path nor oncologic outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.

Oncologic Impact of Pancreatic Fistula

Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancratic Ductal Adenocarcinoma oh the Body and the Tail : a Multicentre Retrospective Cohort Analysis / POPF-DSS (Postoperative Pancreatic Fistula - Disease Specific Survival)

The primary aim of this study is to assess the impact of clinically relevant (CR-) POPF on patient disease specific survival (OS and DFS) after curative distal pancreatectomy.

Secondary end-points of the analysis are aimed at identifying positive and negative prognostic factors and at investigating the role of POPF in specific site recurrence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail	NCT00500968	Pancreas Cancer Fistula	stent Distal pancreat...	20 Years -	Karolinska Institutet
Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy	NCT01384617	Pancreatic Canc... Pancreatic Cyst... Chronic Pancrea... Pancreatic Neur... Pancreatic Pseu...	Stapling closur... Roux-en-Y anast...	20 Years -	Wakayama Medical University
Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection	NCT01058746	Pancreatic Canc...	restrictive per... Liberal periope...	18 Years -	Memorial Sloan Kettering Cancer Center
Multivisceral Resection in Distal Pancreatectomy	NCT04317352	Pancreatic Neop... Surgical Proced...	MVR	18 Years -	Universidad de Extremadura
Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail	NCT00500968	Pancreas Cancer Fistula	stent Distal pancreat...	20 Years -	Karolinska Institutet
Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail	NCT00500968	Pancreas Cancer Fistula	stent Distal pancreat...	20 Years -	Karolinska Institutet
Pancreas Resection With and Without Drains	NCT01441492	Pancreas Tumor Pancreatitis	No Drains Drains	18 Years -	Baylor College of Medicine
Pancreas Resection With and Without Drains	NCT01441492	Pancreas Tumor Pancreatitis	No Drains Drains	18 Years -	Baylor College of Medicine
Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy	NCT01384617	Pancreatic Canc... Pancreatic Cyst... Chronic Pancrea... Pancreatic Neur... Pancreatic Pseu...	Stapling closur... Roux-en-Y anast...	20 Years -	Wakayama Medical University
Oncologic Impact of Pancreatic Fistula	NCT04348084	PDAC of the Bod... CR- POPF		18 Years - 85 Years	University Hospital, Montpellier

Spots Global Cancer Trial Database for distal pancreatectomy