Neoplasms

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Neoplasms by Histologic Type

Patients who underwent Whipple over the splenic artery (WOTSA) as a treatment for PDAC

Patients who underwent total pancreatectomy (TP) as a treatment for PDAC

Treatment for pancreatic ductal cell adenocarcinoma

Whipple over the splenic artery

Total pancreatectomy

Ting-Chun Kuo

Ting-Chung Kuo

Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).

Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).

Methods: The study group comprised 40 consecutive patients who underwent WOTSA for PDAC. Their clinicopathological characteristics and survival were compared with those of a historical control group comprising 30 consecutive patients who underwent TP between.

Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study

Measurement of the physiological parameters

Measurement of the remnant pancreatic volume

Measurement of the remnant pancreatic volume and physiological parameters

National Taiwan University Hospital

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Radical Antegrade Modular Pancreatectomy with Splenectomy

Radical Antegrade Modular Pancreatectomy without splenectomy

distal pancreatectomy without pancreatectomy

When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is usually performed not only for margin-negative resection but also for effective clearance of the splenic hilar lymph nodes. However, there was no scientific evidence regarding the justifiability for spleen resection. Considering potential immunological function of the spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in terms of short-term perioperative outcomes and disease-specific overall survival.

Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer

(e.g. postoperative pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, postoperative bleeding, wound infection, etc.)

Yonsei University

Symptoms and General Pathology

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

The FEP-BY02 HIFU system uses extracorporeal generated high intensity ultrasound, focused on a tumor region of interest, to ablate tissue. A stand-alone B-mode ultrasound is used to locate and define the tumor region of interest. Once defined, the acoustic energy is delivered using a large aperture; fixed focus; sparse transducer array. The concentration of acoustic energy may result in thermal and/or mechanical bioeffects including tissue necrosis, apoptosis, and/or disruption (temporary or permanent) of normal cellular function within the targeted volume (such as nerve conduction).

The FEP-BY02 High Intensity Focused Ultrasound (HIFU) system is intended to ablate ductal adenocarcinoma of the pancreas with ultrasound-guided targeted delivery of focused ultrasound energy to effect thermal and/or mechanical bioeffects leading to ablation (destruction) of the targeted tumor tissue.

High intensity focused ultrasound, HIFU

Joo Ha Hwang, MD, PhD

This is an open-label, non-randomized, single-center, therapeutic trial in patients with AJCC Stage III or IV pancreatic cancer with tumor related abdominal and/or back pain to evaluate the safety of high intensity focused ultrasound therapy using the FEP-BY02 HIFU system for palliation of pancreatic cancer-related pain. Patients meeting all eligibility criteria without any exclusion criteria will be offered an opportunity to participate in the study. After obtaining informed consent a baseline history, physical examination, laboratory studies, and any additional imaging studies needed will be performed.

The major theoretic risk to the patient with this procedure is the development of acute pancreatitis. If acute pancreatitis were to develop, it should become clinically evident by day 3 following HIFU ablation. Therefore, the initial phase of this pilot study is designed to allow a sufficient interval between HIFU treatments to identify whether this theoretic risk will manifest clinically. Previous clinical experience in China suggests that HIFU of pancreatic tumors is safe without risk of developing severe acute pancreatitis.

Patients treated with HIFU will have approximately 15-20% of the tumor volume treated per session. The first 5 patients (feasibility study) will receive their first HIFU treatment followed by a 3-5 day interval for observation.

Following the feasibility study the results will be reviewed with the FDA. If no serious adverse events are encountered, and the FDA agrees with continuing the study, then the next 5 patients will be treated with an interval of 2-3 days between each treatment. If no serious adverse events are encountered in this group, then the next group of 5 patients will be treated at intervals of 1-2 days between each treatment.

High Intensity Focused Ultrasound Tumor Treatment for Pancreatic Cancer Pain

An Open Label, Non-Randomized, Single-Center, Therapeutic Trial Examining the Feasibility, Safety, and Efficacy of FEP-BY02, a High Intensity Focused Ultrasound Tumor Treatment Device, in Patients With Pancreatic Cancer Pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study	NCT06119776	Ductal Adenocar...	Whipple over th... Total pancreate...	20 Years -	National Taiwan University Hospital
Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer	NCT01875198	Left-sided Panc... Ductal Adenocar...	Radical Antegra... Radical Antegra...	20 Years - 80 Years	Yonsei University
High Intensity Focused Ultrasound Tumor Treatment for Pancreatic Cancer Pain	NCT00637364	Pain Pancreatic Aden... Ductal Adenocar...	High intensity ...	18 Years -	CMED HIFU Development Corporation
Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer	NCT01875198	Left-sided Panc... Ductal Adenocar...	Radical Antegra... Radical Antegra...	20 Years - 80 Years	Yonsei University

Spots Global Cancer Trial Database for ductal adenocarcinoma