## Protocol Section
### Identification Module
**NCT ID:** NCT06424431

**Brief Title:** Methods of Pancreatic Stump Closure for Distal Pancreatectomy

**Official Title:** Stapler Versus Stapler Combined With Electrocautery for Pancreatic Transection and Stump Closure for Distal Pancreatectomy

#### Organization Study ID Info
**ID:** CHEC2024-110
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-01-31

**Type:** ACTUAL

#### Start Date
**Date:** 2019-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-03
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Changhai Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation.

**Detailed Description:** The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation. This study aims to determine which method is safer and more feasible, with the potential to reduce postoperative complications, improve outcomes, facilitate better patient recovery, and thereby provide better guidance for clinical practice.

### Conditions Module

**Conditions:**

- Pancreatectomy

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 487

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Simple closure with a closure device for closure of the pancreatic remnant in distal pancreatectomy.

**Intervention Names:**

- Procedure: simple closure with a closure device

**Label:** Stapler

**Type:** OTHER

#### Arm Group 2

**Description:** Closure with a closure device combined with electrocoagulation for closure of the pancreatic remnant in distal pancreatectomy.

**Intervention Names:**

- Procedure: stapler combined with electrocautery

**Label:** Stapler combined with electrocautery

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Stapler combined with electrocautery

**Description:** Closure with a closure device combined with electrocoagulation for pancreatic stump closure in distal pancreatectomy

**Name:** stapler combined with electrocautery

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Stapler

**Description:** Simple closure with a closure device for pancreatic stump closure in distal pancreatectomy

**Name:** simple closure with a closure device

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Postoperative pancreatic fistula

**Measure:** Postoperative pancreatic fistula

**Time Frame:** perioperatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients who underwent distal pancreatectomy performed by Director Jin Gang's team at Changhai Hospital affiliated with Naval Medical University between January 2019 and January 2023.
* Patients who underwent closure of the pancreatic remnant using either simple closure or closure combined with electrocoagulation during surgery.

Exclusion Criteria:

* Patients undergoing surgeries by other primary clinical teams during the same period.
* Patients undergoing closure of the pancreatic remnant using methods other than those mentioned.
* Patients who violate the requirements of the study protocol.
* Patients with incomplete data collection in the hospital's diagnostic and treatment system.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shanghai

**Country:** China

**Facility:** Changhai Hospital

**State:** Shanghai

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
