## Protocol Section
### Identification Module
**NCT ID:** NCT06417567

**Brief Title:** The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study

**Official Title:** The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study

#### Organization Study ID Info
**ID:** NEPA
#### Organization
**Class:** OTHER
**Full Name:** Tianjin Medical University Cancer Institute and Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tianjin Medical University Cancer Institute and Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The rapid progress of multiple antiemetic regimens ensures that patients can receive full dose chemotherapy, however, there are still a large number of unmet clinical needs in patient evaluation and treatment. Due to the fact that patients with liver, gallbladder, and pancreatic diseases undergoing surgery are still in the stage of nausea and vomiting, the actual incidence of delayed nausea and vomiting may be underestimated. The long-term effective control of nausea and vomiting by Nitopitan Palonosetron capsules may improve the quality of life of patients during and after treatment, and ultimately improve clinical outcomes

### Conditions Module

**Conditions:**

- General Anesthesia Gastrointestinal Cancer Surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Year

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: NEPA

**Label:** experimental group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- experimental group

**Description:** NEPA in Preventing Postoperative Nausea and Vomiting after General Anesthesia Gastrointestinal Cancer Surgery

**Name:** NEPA

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** defined as no vomiting, no use of rescue medication, VAS nausea score\<4

**Measure:** Complete response rate within 24 hours after surgery

**Time Frame:** 3month

#### Secondary Outcomes

**Description:** Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours)

**Measure:** Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours)

**Time Frame:** Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1. Male or female, aged 18-65 years old; 2. The subjects were diagnosed with liver, gallbladder, and pancreatic diseases through histology or cytology and underwent elective surgical treatment, including but not limited to pancreaticoduodenectomy, liver resection, bile duct stone removal, etc., and received treatment with Netopitam Palonosetron capsules; 3. The subject is not in lactation period; 4. When screening female patients with potential pregnancy, it is necessary to confirm that the pregnancy test must be negative; 5. The subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent form.

Exclusion Criteria:

* 1) Serious liver and kidney dysfunction, cardiopulmonary dysfunction, or other serious diseases have not received standardized treatment; 2) Having a serious mental illness in the past; 3) Take antiemetics or antidepressants within 48 hours before surgery; 4) Patients receiving systemic glucocorticoid treatment within 4 weeks prior to surgery; 5) Take NK1 receptor antagonists or any investigational drugs within 4 weeks prior to the start of the experiment; 6) Use CYP3A4 inducer within 4 weeks prior to surgery, and CYP3A4 substrate or potent, moderate CYP3A4 inhibitor within 1 week; 7) Pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures; 8) Drug and/or alcohol abuse; 9) Hypocalcemia or any other condition that may cause vomiting; 10) The subject has an allergic reaction to Netopitam Palonosetron capsules or any of their excipients; 11) Participate in another clinical study within 30 days prior to baseline visit, using any exploratory drugs or devices; Allow participation in observational research; 12) Researchers assess other situations that may affect the progress of clinical research and the determination of research results.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** This study is a retrospective study to evaluate the efficacy and safety of Netopitam Palonosetron Capsules in preventing nausea and vomiting caused by surgical treatment in patients with liver, gallbladder, and pancreatic diseases, providing evidence-based evidence and medication basis for the use of Netopitam Palonosetron Capsules in clinical practice.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tianjin

**Contacts:**

***Contact 1:***

- **Email:** lihuikai@tjmuch.com

- **Name:** Huikai Li

- **Phone:** +862223340123

- **Phone Ext:** 3091

- **Role:** CONTACT

**Country:** China

**Facility:** Tianjin Medical University Cancer Institute & Hospital

**State:** Tianjin

**Status:** RECRUITING

**Zip:** 300060

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009325

- Term: Nausea

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12273

- Name: Nausea

- Relevance: LOW

- As Found: Unknown

- ID: M17582

- Name: Vomiting

- Relevance: HIGH

- As Found: Vomiting

- ID: M22074

- Name: Postoperative Nausea and Vomiting

- Relevance: HIGH

- As Found: Postoperative Nausea and Vomiting

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: HIGH

- As Found: Gastrointestinal Cancer

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000014839

- Term: Vomiting

- ID: D000020250

- Term: Postoperative Nausea and Vomiting

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
