UMIN-ICDS Clinical Trial

Public title

Safety of continuous suturing for pancreatic duct-to-jejunum anastomosis in pancreaticoduodenectomy

Acronym

Continuous-suture pancreaticojejunostomy pilot study

Scientific Title

Safety and feasibility of continuous-suture duct-to-mucosa pancreaticojejunostomy in pancreaticoduodenectomy: a single-center, single-arm pilot study

Scientific Title:Acronym

CS-PJ pilot study

Region

Japan

Condition

Pancreatic head and periampullary tumors

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To prospectively evaluate the safety and feasibility of continuous-suture duct-to-mucosa pancreaticojejunostomy in pancreaticoduodenectomy (PD), focusing on the incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) within 90 days after surgery. The data will be used to estimate the effect size, calculate the sample size, and standardize the technique for a future multicenter randomized controlled trial comparing continuous and interrupted sutures.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Incidence of clinically relevant postoperative pancreatic fistula (CR-POPF; ISGPS 2016 definition, grade B/C) within 90 days after surgery

Key secondary outcomes

1) Incidence of CR-POPF according to the institutional criteria (cases in which the existing drain was only exchanged and removed within 21 days after surgery are classified as biochemical leak)
2) Postoperative complications within 90 days (Clavien-Dindo classification; grade IIIa or higher as severe)
3) Delayed gastric emptying (DGE) and postpancreatectomy hemorrhage (PPH) (ISGPS definitions)
4) Pancreaticojejunostomy time (from the first stitch to completion of tying)
5) Operative time and blood loss
6) Drain fluid amylase on postoperative days 1 and 3
7) Length of postoperative hospital stay, and readmission, reoperation, and mortality within 90 days
8) Main pancreatic duct diameter on CT (preoperative and 6 and 12 months after surgery) and drainage procedures for pancreatic duct stricture within 12 months
9) Feasibility: proportion of enrolled patients in whom continuous suturing was completed, and reasons for conversion to interrupted sutures

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Duct-to-mucosa pancreaticojejunostomy in pancreaticoduodenectomy (including pylorus-preserving and subtotal stomach-preserving PD; open, laparoscopic, or robot-assisted) is performed with continuous sutures using 5-0 PDS. If the surgeon judges continuous suturing to be difficult or unsafe during surgery, the anastomosis is immediately converted to interrupted sutures.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients scheduled for pancreaticoduodenectomy (including pylorus-preserving and subtotal stomach-preserving PD) with reconstruction by duct-to-mucosa pancreaticojejunostomy
2) Aged 18 years or older at the time of consent
3) Written informed consent obtained from the patient
4) Regardless of disease (benign or malignant) or approach (open, laparoscopic, or robot-assisted)

Key exclusion criteria

1) Patients scheduled for pancreatic reconstruction other than duct-to-mucosa pancreaticojejunostomy, such as pancreaticogastrostomy or pancreatic duct ligation
2) Patients scheduled for total pancreatectomy
3) Patients requiring combined resection of major adjacent organs, such as hepatectomy or colectomy (combined resection of the portal vein/superior mesenteric vein and partial resection of adjacent organs are allowed)
4) Patients expected to require arterial reconstruction, such as of the common hepatic artery or celiac artery
5) Patients with severe ischemic heart disease
6) Patients with liver cirrhosis or active hepatitis
7) Patients with dyspnea requiring oxygen therapy due to interstitial pneumonia, pulmonary fibrosis, or other conditions
8) Patients on dialysis for chronic renal failure
9) Patients with active synchronous cancer considered to affect adverse events or overall survival
10) Patients on long-term oral steroids considered to affect adverse events
11) Patients who cannot receive either iodinated or gadolinium-based contrast agents due to severe drug allergy
12) Patients judged to lack the capacity to consent
13) Patients with psychosis or psychiatric symptoms that make participation in the study difficult
14) Other patients judged inappropriate by the principal investigator or sub-investigators

Target sample size

20

Name of lead principal investigator

1st name	Takumi
Middle name
Last name	Kitahama

Organization

Hyogo Medical University

Division name

Division of Hepato-Biliary-Pancreatic Surgery, Department of Gastroenterological Surgery

Zip code

663-8501

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan

TEL

0798-45-6582

Email

ta-kitahama@hyo-med.ac.jp

Name of contact person

1st name	Takumi
Middle name
Last name	Kitahama

Organization

Hyogo Medical University

Division name

Division of Hepato-Biliary-Pancreatic Surgery, Department of Gastroenterological Surgery

Zip code

663-8501

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan

TEL

0798-45-6582

Homepage URL

Email

ta-kitahama@hyo-med.ac.jp

Institute

Hyogo Medical University

Institute

Department

Personal name

Organization

Hyogo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Review Committee, Hyogo Medical University

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan

Tel

0798-45-6066

Email

rinri@hyo-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

兵庫医科大学病院（兵庫県）

Date of disclosure of the study information

2026

Year

10

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

12

Month

01

Day

Last follow-up date

2028

Year

12

Month

31

Day

Date of closure to data entry

2029

Year

01

Month

31

Day

Date trial data considered complete

2029

Year

02

Month

28

Day

Date analysis concluded

2029

Year

03

Month

31

Day

Other related information

This single-center pilot study precedes a planned multicenter randomized controlled trial comparing continuous and interrupted sutures for duct-to-mucosa pancreaticojejunostomy. The incidence of CR-POPF, anastomosis time, and completion rate of continuous suturing obtained in this study will be used to estimate the effect size, calculate the sample size, and standardize the technique for that trial.

Registered date

2026

Year

10

Month

20

Day

Last modified on

2026

Year

10

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072523