An observational study in Mild Gallstone Pancreatitis, Acute Pancreatitis and Gallstones, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Sohag University · Observational
The purpose of this study is to evaluate the clinical, surgical, and postoperative outcomes of early laparoscopic cholecystectomy performed during the index hospital admission in adult patients presenting with mild gallstone pancreatitis.
Gallstone disease represents a primary cause of acute pancreatitis. While definitive cholecystectomy is essential to prevent recurrent biliary complications, the optimal timing has often been debated. Current guidelines advocate for same-admission cholecystectomy once the acute pancreatitis subsides; however, concerns regarding inflammation, adhesions around Calot's triangle, and potential surgical difficulty frequently influence practical decision-making. This study assesses the overall safety, feasibility, conversion rates to open surgery, complication profile, hospital stay, and recurrence rates among patients managed at Sohag University Hospital.
Acute pancreatitis is an acute inflammatory disorder of the pancreas predominantly caused by gallstones or biliary sludge obstructing the ampulla of Vater. Mild gallstone pancreatitis, as defined by the Revised Atlanta Classification, is characterized by the absence of local or systemic complications and organ failure, resolving promptly with conservative supportive treatment. Nevertheless, delaying definitive surgical treatment exposes patients to recurrent biliary colic, recurrent pancreatitis, acute cholecystitis, and emergency readmission.
This prospective observational study was conducted at the Department of General Surgery, Sohag University Hospital. Consecutive adult patients (aged 18 years or older) diagnosed with mild acute gallstone pancreatitis who undergo initial supportive medical stabilization and are planned for early laparoscopic cholecystectomy during the same hospital admission will be enrolled.
Preoperative baseline assessments include clinical evaluation, biochemical testing (pancreatic enzymes, liver function tests, complete blood count, and inflammatory markers), and abdominal ultrasonography to assess gallstones, common bile duct status, and gallbladder wall changes. Patients undergo early laparoscopic cholecystectomy following initial stabilization. Intraoperative variables (operative time, Calot's triangle dissection difficulty, adhesions, bile spillage, bleeding, and conversion to open surgery) and postoperative outcomes (pain, wound infection, bile leakage, intraperitoneal collections, length of hospital stay, 30-day readmissions, and recurrent biliary events) are systematically collected and analyzed.
558 studies on the registry are indexed under Pancreatitis; 165 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 193 observational studies indexed under Pancreatitis.
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Adult patients presenting with mild acute gallstone pancreatitis who are admitted to the General Surgery Department at Sohag University Hospital and considered fit for early laparoscopic cholecystectomy during the index admission following initial clinical and biochemical stabilization.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Consecutive adult patients presenting with mild acute gallstone pancreatitis who undergo initial supportive medical stabilization and receive early laparoscopic cholecystectomy during the same index hospital admission.
Procedure: Early Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy performed during the index admission following initial clinical and biochemical stabilization for mild acute gallstone pancreatitis.
Number of Participants With Successful Early Laparoscopic Cholecystectomy Without Conversion or Major Complications
Defined as the number of patients who successfully undergo and complete early laparoscopic cholecystectomy during the index admission without conversion to open surgery, intraoperative bile duct or vascular injury, or major postoperative complications (such as bile leak, hemorrhage, or intra-abdominal collection requiring reintervention) graded Clavien-Dindo grade III or higher
Time frame: From date of surgery through 30 days postoperatively
Conversion Rate to Open Cholecystectomy
Percentage of patients requiring conversion from laparoscopy to open surgery and reasons for conversion.
Time frame: Intraoperatively
Operative Time
The duration of the surgical procedure is measured in minutes from the initial incision to final closure.
Time frame: Intraoperatively
Postoperative Morbidity Rate
Incidence of postoperative complications, including wound infection, bile leak, intra-abdominal fluid collections, and hemorrhage.
Time frame: Up to 30 days postoperatively
Length of Hospital Stay
Total number of postoperative days and total hospital admission days until discharge.
Time frame: Through hospital discharge, up to 14 days
Hospital Readmission Rate
Rate of unexpected hospital readmission related to pancreatitis, recurrent biliary events, or surgical complications.
Time frame: Within 30 days after hospital discharge
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 82 non-industry observational studies under Pancreatitis, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 133. This study's planned 12 months is below that.
Counting every sponsor, half of 86 studies reached it within 50 months; a quarter within 21 and three quarters within 133.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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