Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-12-01

Brief Summary

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The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.

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Detailed Description

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Distal pancreatectomy (DP) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.Laparoscopic distal pancreatectomy (LDP) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. Pancreatic fistula (PF) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. Frequencies range from 5% to 64%. Several procedures have been proposed to reduce the rate of PF. stapler closure is considered to be safe and approved particularly in LDP. Numerous predictive factors for PF have been reported in previous studies. Among these risk factors, the most important might be the texture and thickness of the remnant pancreas. However, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. Furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. Therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Patients were stratified intraoperatively by gland texture-hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. Pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell.

Conditions

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Pancreatic Neoplasms Pancreatic Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Tri-Staple reloads

Tri-Staple reloads were used for pancreatic stump texture

Group Type EXPERIMENTAL

Tri-Staple reloads

Intervention Type PROCEDURE

Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump

traditional reloads

the traditional reloads were used for pancreatic stump texture

Group Type ACTIVE_COMPARATOR

traditional reloads

Intervention Type PROCEDURE

Blue cartridge with3.0mm height staple was used for pancreatic stump

Interventions

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traditional reloads

Blue cartridge with3.0mm height staple was used for pancreatic stump

Intervention Type PROCEDURE

Tri-Staple reloads

Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. disease of pancreatic body and tail
2. Age: 18 years or older
3. distant metastases are not diagnosed preoperatively.
4. Patients who can provide written informed consent

Exclusion Criteria

1. Patients with severe organ disease such as cardiac disease,respiratory illness
2. Patients with pancreaticojejunostomy,pancreatogastrostomy
3. Patients with conversion to laparotomy
4. Patients with pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No