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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital

About this trial

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. Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate) 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Inverted-Ω Anastomosis

    Procedure/Surgery

    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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Inverted-Ω AnastomosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and assessment of the surgical process

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

Time frame
During operation
2

Operative time

Operative time

Time frame
During operation
3

Intraoperative blood loss

Intraoperative blood loss

Time frame
During operation
4

Postoperative complications

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

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

Secondary outcomes

1

Short-term survival

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: