Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy

NCT07087392 | Not Yet Recruiting

• 1 other identifier: 2025-550
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are:

1. 1.Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate)
2. 2.What is the incidence and severity of postoperative complications in inverted -Ω anastomosis? What advantages does it have over conventional anastomosis methods such as roux-en-y？

Conditions

Pancreatic Cystic Neoplasms

Outcome Measures

Primary Outcomes (4)

• Safety and assessment of the surgical process

  The incidence of intraoperative adverse events such as conversion to open surgery rate

  During operation

• Operative time

  Operative time

  During operation

• Intraoperative blood loss

  Intraoperative blood loss

  During operation

• Postoperative complications

  The incidence and severity of postoperative complications, as defined by the International Study Group on Pancreatic Surgery (ISGPS)

  From the date of surgery (Day 0) up to 90 days postoperatively

Secondary Outcomes (1)

• Short-term survival

  From the date of surgery (Day 0) up to 3 years postoperatively

Study Arms (1)

Inverted-Ω Anastomosis

EXPERIMENTAL

After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract

Procedure: Inverted-Ω Anastomosis

Interventions

Inverted-Ω Anastomosis PROCEDURE

After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract

Inverted-Ω Anastomosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years old, gender not limited;
• Patients diagnosed with benign or low-grade malignant tumors in the head or middle section of the pancreas by CT or MRI;
• ECOG score 0-1.

You may not qualify if:

• Those with severe heart, liver or kidney insufficiency, or those who are assessed as intolerant to surgery or anesthesia, or those with ASA grade \> 3;
• Patients with a history of or concurrent other malignant tumors, or other serious infections or infectious diseases, or those who are unable to complete the anastomosis surgery;
• Uncontrollable concomitant diseases, including but not limited to severe coronary artery disease, COPD or asthma, uncontrollable cerebrovascular diseases, symptomatic congestive failure, unstable angina pectoris, arrhythmia, or other diseases that the researchers consider ineligible for enrollment;
• Patients who have undergone other upper abdominal surgeries and digestive tract reconstruction procedures in the past;
• Patients requiring combined organ resection;
• Preoperative assessment suggested that the patient might have factors such as active ulcers and bleeding in the digestive tract;
• Pregnant and lactating women;
• Any uncertain factors that have an impact on the patient's safety or compliance.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Central Study Contacts

Zhong Wu

CONTACT

+86 189 8060 6518; wuzhong0057@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 28, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)