Prospective Observational Study on the Indications, Efficacy, and Safety of Conversion Surgery After Non-Surgical Treatment for Locally Advanced or Metastatic Pancreatic Cancer (JG Project-01)

POTE-CON Study: A Prospective Observational Study Evaluating the Indications, Efficacy, and Safety of Conversion Surgery Following Non-Surgical Treatment for Locally Advanced or Metastatic Pancreatic Cancer - POTE-CON Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060823

Enrollment

100

Registered

2026-03-05

Start date

2021-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Pancreatic Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged over 20 years at the time of informed consent. 2. Patients diagnosed with unresectable pancreatic cancer at the initial presentation, defined by major arterial involvement and/or distant metastasis. 3. Borderline resectable pancreatic cancer (BRA): Tumor contact or invasion of under 180 degrees with the celiac axis (CA) and/or common hepatic artery (CHA), and/or under 180 degrees contact with the superior mesenteric artery (SMA) without definite arterial encasement. 4. Potentially convertible pancreatic cancer, defined as follows: (a) Potentially convertible locally advanced pancreatic cancer (URLAPC): Tumor contact or invasion of 180 to 360 degrees with the celiac axis (CA) and/or common hepatic artery (CHA), and/or 180 to 360 degrees contact with the superior mesenteric artery (SMA) without definite encasement; or invasion of the portal vein (PV) deemed unreconstructable. (b) Potentially convertible metastatic pancreatic cancer (URMPC): (1) Patients meeting any of the following conditions: Up to three liver metastases (2) Metastatic involvement in up to two sites among liver metastasis, lung metastasis, and para-aortic lymph node metastasis (multiple organs allowed) (3) Positive peritoneal cytology (CY1) without macroscopic peritoneal dissemination, confirmed by staging laparoscopy. 5. Patients planned to undergo non-surgical treatment and who understand and agree to the possibility of conversion surgery (CS) thereafter. 6. Adequate organ function and general condition judged sufficient to tolerate surgical resection. 7. Written informed consent obtained from the patient after receiving a full explanation of the study and demonstrating adequate understanding.

Exclusion criteria

Exclusion criteria: 1. Patients younger than 20 years of age at the time of informed consent. 2. Patients with resectable pancreatic cancer at the initial diagnosis. 3. Tumor conditions exceeding the above eligibility criteria, such as definite encasement or severe narrowing of the superior mesenteric artery (SMA) or peritoneal dissemination. 4. Patients for whom conversion surgery (CS) is not intended at the time of enrollment, or those who do not agree to the possibility of CS after non-surgical treatment. 5. Patients judged unable to tolerate surgical resection due to poor general condition. 6. Patients with recurrent pancreatic cancer. 7. Patients deemed inappropriate for participation in the study by the principal investigator for any other reason.

Design outcomes

Primary

Measure	Time frame
Conversion rate and R0 resection rate	—

Secondary

Measure	Time frame
a. Postoperative in-hospital mortality b. Postoperative perioperative complication rate c. Overall survival after initiation of treatment d. Patterns of recurrence e. Changes in serum tumor marker levels	—

Countries

Japan

Contacts

Public ContactSho Kiritani

Cancer Institute Hospital of JFCR Hepatobiliary and Pancreatic Surgery Division

sho.kiritani@gmail.com0335200111

Outcome results